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Current UW COVID-19 Clinical Research

Current UW COVID-19 Clinical Research

ITHS is actively compiling a list of approved COVID-19 research projects with information valuable to interested scientists and participants. This list will be updated as more trials become available.

If you are an investigator interested in submitting a COVID-19 research application, please check the list below to avoid duplicative studies.

Study TitleCategoryPrincipal InvestigatorDescriptionStudy Population
Convalescent plasma as therapy for COVID-19 infectionTreatment, PreventionAnna WaldTo identify eligible donors for collection of anti-SARS-CoV-2 immune plasma from volunteers who are convalescent survivors of COVID-19 illnessVirologically documented SARS-CoV-2 infection; 18 years or older; >28 days complete resolution of symptoms; good general health
SARS-CoV-2 Immune Responses in Vulnerable PopulationsImmunologyKristina Adams-Waldorf1. Determine sex, age, and pregnancy specific immunopathologies of COVID-19. 2. Define transcriptional and protein networks induced by SARS-CoV-2 infection including pathways that mediate viral entry and replication.Blood samples from healthy volunteers in 4 separate cohorts (n=40): healthy non-pregnant women, healthy men, healthy older female and male adults >65 years; 30 pregnant women with active COVID-19 infections who are "close to delivery"
Understanding emergency clinicians' experiences of providing care during the COVID-19 pandemicHealth ServicesDave LuTo explore emergency clinicians' (attending and resident physicians, nurses, care technicians, and other emergency staff) experiences of providing care during the COVID-19 pandemic. To explore emergency clinicians' perspectives on departmental and institutional actions that are helpful or hinder their ability to deliver care during the COVID-19 pandemic.Emergency clinicians practicing within the ED departments at Maine Medical Center, both campuses of the UWMC, and HMC.
Seattle Flu StudyEpidemiologyHelen ChuThis study aims to determine the rate and spread of respiratory pathogens including SARS-CoV-2 in an urban population using innovative techniques for self-collection, self-testing, sample delivery, and data collection.Adults and children with viral respiratory infections
Hospitalized or Ambulatory Adults with Respiratory Viral Infections (HAARVI)ImmunologyHelen ChuHAARVI is an immune profiling study of adults with confirmed COVID-19. This study aims to characterize the immune response to COVID infection and to establish a biorepository for the development of vaccines and monoclonal antibodies.Adults with confirmed COVID-19
A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients with COVID-19TreatmentShelly KarunaThis is an adaptive, phase 1/2/3, randomized, double-blinded, placebo-controlled master protocol to evaluate the efficacy, safety, and tolerability of REGN-COV2 combination therapy with two antibodies in outpatient (ie, ambulatory) adult, pregnant women with SARS-CoV-2 infection, who are symptomatic. The cohort that includes enrollment of pregnant women will all receive active product, no placebo.Pregnant women ≥18 years of age with documented SARS-CoV-2 infection within the past 72 hours, experiencing at least one symptom common of COVID-19.
INSPIRE RegistryClinical Epidemiology, TreatmentGraham Nichol, Matthew J. ThompsonThis is a prospective observational cohort study of adults who receive diagnostic testing for COVID-19. This study will enroll subjects in a remote-based model and leverage a digital platform to rapidly collect personal health information from a representative population. This study is set up at the UW and will be one site in a multi-site study.Adults age 18 and over, under investigation for SARS COV-2
A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized AdultsTreatmentHelen ChuFirst therapeutic agent that will be tested is remdesivir.Hospitalized patients with COVID-19 at UWMC and HMC
COVID-19 Prospective Observational CohortBiomarkerPavan BhatrajuNon-interventional, prospective study providing biologic specimens and clinical and molecular data of subjects at risk for COVID-19 infection and related organ dysfunction and death which will inform future biomarker-based approaches for estimating risk as well as interventional studiesAll adult patients with suspected COVID-19 admitted to an ICU at HMC, UWMC-Montlake, or UWMC-Northwest; continuing after discharge
A multi-center, randomized, double-blinded, placebo-controlled study to evaluate the safety and efficacy of hydroxychloroquine monotherapy and in combination with azithromycin in patients with moderate and severe COVID-19 diseaseTherapeutic or Preventative Clincial TrialRachel Bender IgnacioTo demonstrate superiority of hydroxychloroquine or hydroxychloroquine plus azithromycin compared to placebo in achieving clinical response by Day 15.444 male and female adult participants with moderate to severe COVID-19 disease excluding critically ill participants receiving standard of care to be randomized into hydroxychloroquine, hydroxychloroquine plus azithromycin, or placebo in 1:1:1 ratio, 148 subjects per arm.
C5399: Phase 3 randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of ruxolitinib in patients with COVID-19 associated cytokine storm (RUXCOVID)Therapeutic or Preventative Clinical TrialRachel Bender IgnacioThis is a multi-site international trial to evaluate whether ruxolitinib (a JAK21/JAK2 inhibitor) can prevent respiratory failure and cytokine release syndrome in persons with COVID-19 pneumonia. Participants will be randomized 2:1 to receive ruxolitinib or placebo for 14 days in a double-blind study of 402 participants.Hospitalized patients with confirmed COVID-19 at UWMC Montlake and Northwest campuses. Participants must require oxygen and have radiographic evidence of pneumonia. Patients requiring ICU at baseline are excluded.
UWARN COVID-19 Studies to Create Neutralizing Antibodies, Diagnostics, and Understand Immune DysregulationAssay development/ ImmunologyWesley Van VoorhisUWARN will (1) create neutralizing monoclonal antibodies of human origin in collaboration with Michel Nussenzweig's laboratory at Rockefeller University; (2) create diagnostics that emit light, facilitating rapid diagnosis, using the LOCKR technology of the UW Institute for Protein Design; (3) collect blood samples from humans and perform RNAseq and study the cytokines and immune modulators present in the blood50 adult persons in King County area that have recovered from COVID-19 infection. Aim 2: Obtain at least 200 COVID-19 patient samples and 200 control specimens to allow full verification of LOCKR assays. Aim 3: 100 COVID+ adult individuals that can provide consent, at or near King County hospitals. Samples need to be taken from humans severely ill with a viral infection, moderately to mildly ill, and those in the community that are not infected (or fully recovered).
PETAL COVID-19 Observational StudyObservationalTerri HoughRED CORAL - retrospective data collection, BLUE CORAL - prospective data and specimen collectionRED: Adults admitted to HMC/UWMC between March 1-April 1, 2020, who tested positive for COVID-19; BLUE: Adults admitted to HMC, UW-ML and UW-NW who test positive for COVID-19
ORCHID - Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic DiseaseInterventionalTerri Hough, Nick JohnsonHydroxychloroquine vs placebo for COVID-19Adults admitted to HMC who test positive for COVID-19
COVID-19 and Pets Study (CAPs)EpidemiologyPeter RabinowitzThe COVID-19 and Pets Study (CAPS) will provide free COVID-19 testing of animals sharing households with COVID-19 positive patients to learn more about the role companion animals play in the coronavirus outbreak. COVID positive patients and their pets sharing households in King County, WA.
Developing and Evaluating Point-of-Care Antigen and Immunoassays for COVID-19 and Cytokine Release Syndrome among people being screened for SARS-CoV-2 infection in SeattleObservationalPaul DrainThe primary study objective is to determine the diagnostic accuracy and incremental diagnostic yield of performing antigen-based testing and fingerprick serological testing among adults undergoing nasopharyngeal COVID-19 testing in Seattle.Adults (>=18 years) who present for COVID-19 testing at either of the two clinical sites. We will include some asymptomatic participants in this cohort.
Collaborative COVID-19 Survellance and ResearchObservational Mark JutilaProject 1: To assess antibody responses in laboratory and field workers and their immediate connections using the Rapid test and ELISA. Project 2: To amplify and sequence the viral strain that are currently in circulation. Primary objective is to assess the presence of SARS-CoV-2 in samples from patients that do not currently fit the criteria for testing. Project 3: To provide timely and much needed information about the community level of SARS-CoV2 infections in Montana.Project 1: Antibody positive volunteers, ~300; Project 3: Two tiers of testing in Gallatin County and select rural and tribal communities in Montana. Targeted testing of blood samples with high-risk occupation workers and patients with mild COVID-19 symptoms, and random sampling using thumb prick testing of individuals across gender and age groups. For random sampling, anticipate surveying 5% of the population of each study community across gender and age groups, up to 7,500 individuals.
Efficacy and Mechanisms of action of HydroxychloroquineObservationalKeith Elkon1. Determine if patients with COVID-19 produce IFN-I, which has pathologic effects with worse disease outcomes. 2. HCQ is protective because it reduces IFN-I and perhaps other pathologic cytokines such as IL-6.Two distinct groups admitted to UW based on treatment categories: (1) HCQ exposure and (2) all other non-HCQ treatment regimens. Numbers may increase with tentative collaboration with colleagues at New York Hospital.
Analysis of antibody-mediated innate immune effector functions induced by COVID-19 convalescent plasmaObservationalBronwyn Gunn1. Define the landscape of antibody-mediated innate immune effector functions induced by convalescent plasma of recovered COVID-19 patients. 2. Determine if antibody-mediated activated of innate immune cells can contribute to immunopathology and damage to lung epithelial cells.Plasma samples from different COVID-19 convalescent patients.
Assessing the exposure risk to heath care workers while working in the COVID-19 pandemicObservationalDaniel Henning1. Health care workers (HCW) will have higher rates of COVID-19 seroconversion than the general population. 2. COVID-19 seroconversion rates differ among hospital settings.Multi-centered (10 sites), observational cohort of HCWs; a cohort of ED patients without symptoms of viral syndrome who are discharged from hospital to serve as controls. HCW who are currently asymptomatic and have not had positive COVID-19 test.
Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults - An Adaptive Randomized Platform TrialInterventionalChristine JohnstonRandomized (participant-blinded, treating clinician-blinded, laboratory-blinded, pharmacist-unblinded, statistician-unblinded), multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of HCQ and LPV/r for the treatment of SARS-CoV-2 infection in high risk adults not requiring hospital admission. Additional arms will be added should new potential agents be discovered or combination treatments be proposed. Randomization will be stratified by time since symptom onset.SARS-CoV-2 infection within last 72 hours
Integrated multiomics of COVID-19ObservationalEoin WestDefine distinctive host responses to COVID-19 infection using a multi-omics approach; leverage multi-omics signatures to define molecular endotypes in COVID-19 infection and build prognostic models for clinically meaningful outcomes (progression to severe disease and death)100 hospitalized COVID-19 patients (50 acute, 50 ICU), 50 COVID-19 outpatients, 50 hospitalized COVID-19-negative patients, and 25 healthy individuals.
A randomized, double-blind, placebo-controlled trial to evaluate the efficacy of hydroxychloroquine and azithromycin to prevent hospitalization or death in persons with COVID-19InterventionalAnn CollierTo determine if HCQ and azithromycin will prevent the composite endpoint of either hospitalization or death by 21 days after study entry.Individuals 18 years of age and older with documented active SARS-CoV-2 infection from any respiratory specimen collected <96 hours prior to study entry who are experiencing at least one of the following symptoms: fever, cough or shortness of breath.
Transcriptomic Maps for Elucidating COVID-19 PathogenesisObservationalShin LinWe plan to procure autopsy samples from a broad range of organs from patients who have expired from COVID-19 (and other causes as controls). We will subject these samples to a wide variety of second generation sequencing technologies. In so doing, we seek to elucidate the cell types involved in the pathogenesis of this disease process and the regulatory changes that occur on a cellular level.Autopsy samples: lung, heart, liver, kidney, spleen, intestine, brain
Serial SARS-CoV-2 Seroprevalence SurveyObservationalMark WenerMeasurement of IgG antibodies to CoV2 in ambulatory primary care clinic population residual sera, and use serial measurements of seroprevalence to provide an estimate of the change in prevalence of resolving and previous CoV2 in the regional population.Residua of specimens coming to UWMC Laboratory Medicine from UW Neighborhood Clinics for routine automated chemistry tests will be retained by the investigators. Lab information system will be searched to identify eligible patients, and a table will be created to identify the tube unique identifier number, the age and sex of the patient, date of draw, clinic site from which specimen was drawn, tests ordered, and results of any previous NAT CoV2 testing.
Demonstrating the Utility of Tasso OnDemand-SST in Remote Serosurveillance in COVID-19InterventionalAndrew HoofnaglePropose to compare Tasso-SST serum to serum obtained by standard phlebotomy at the same time, to evaluate the stability of antibodies to SARS-CoV-2 during shipment, and to demonstrate that patients can use the device at home and ship their sample to the laboratory and that those samples are equivalent to the serum collected by standard phlebotomy.Method comparison: 60 subjects, 30 positive and 30 negative for COVID-19; Stability evaluation: 30 subjects, 15 positive and 15 negative for COVID-19; Usability evaluation: 30 subjects, 15 positive and 15 negative for COVID-19.
Understanding emergency clinicians' experiences of providing care during the COVID-19 pandemicObservationalDave LuTo explore emergency clinicians' (attending and resident physicians, nurses, care technicians, and other emergency staff) experiences of providing care during the COVID-19 pandemic. To explore emergency clinicians' perspectives on departmental and institutional actions that are helpful or hinder their ability to deliver care during the COVID-19 pandemic.Emergency clinicians practicing within the ED departments at Maine Medical Center, both campuses of the UWMC, and HMC.
COPE Study: COVID-19 Outcomes in Physical hEalthObservationalJames AndrewsTo compare physical function outcomes between older and younger survivors of hospitalization for COVID-19.Individuals (18-64 years n=100; ages 65 and older n=100) who have been hospitalized for COVID-19 (either suspected or confirmed) at UWMC or HMC.
Arrhythmic Complications of COVID-19ObservationalNeal ChatterjeeTo determine the incidence of atrial, ventricular, and brady-arrhythmias in COVID-19 during multiple phases of illness including in hospital and immediate post-discharge. To compare the incidence of arrhythmias in post-hospital COVID-19 patients to those from age, sex, and race matched controls from population-based cohort studies and post-myocardial infarction patients who have worn 14-day monitoring devices.Aim1a: Adults admitted to UW hospital system from February 2020 onwards and diagnosed with COVID-19 (anticipate n~600). Aim1b: Study cohort compromised of all COVID-19 patients identified prospectively, n~200.
Identification of Respiratory Tract Pathogens in COVID-19 Positive and Negative Specimens Submitted for COVID-19 testingObservationalStephanie CarnesAim 1: Assess the prevalence of co-infections in COVID-19 patients and their impact on clinical presentation; Aim 2: Identify clinical criteria to allow COVID-19 risk stratification of patients presenting with acute respiratory symptoms; Aim 3: Determine how social distancing measures have altered the epidemiology of viral respiratory infectionsPatient population (UWMC, UWNW, and HMC) primarily consists of outpatients (50%) and ED patients (35%), providing a range of severity. Leftover nasopharyngeal swab samples from UW Medicine patients with acute symptoms who were tested for SARS-COV-2 will be run on the BioFire Respiratory Panel to determine an alternative etiology or co-infection with bacterial or viral agents. Medical records will be reviewed to determine associated clinical features and correlate them with infectious etiology.
eMERGE SARS-CoV-2 Supplement: Defining pulmonary and renal electronic health record phenotypes and host genetic susceptibilityObservationalGail JarvikThis work is proposed as a supplement to our eMERGE grant to develop transferable electronic health record (EHR) phenotyping that standardizes phenotype across studies and develop polygenetic risk scores (PRS) that predict those phenotypes, allowing for pre-diagnosis testing, risk stratification, and and increased preventive strategies or screening to protect health. Here we propose to develop renal and pulmonary EHR phenotyping of COVID-19 patients. We propose to compare the host genetics of mildly and severely affected COVID-19 patients and determine whether a PRS for baseline WBC traits predicts COVID-19 severity.~250 UWMC inpatient DNA already being collected (re/consented). We proposed to collect buccal DNA using home swab kits for ~500 UWMC COVID-19 patients who were never admitted.
Defining the COVID-19 outbreak in Blaine County, IdahoObservationalKeith JeromeThe study's primary objective is to provide detailed and reliable data that will be critical for local, state, and national policy makers as we move to the next stages of the COVID-19 pandemic. The primary objectives of this proposal are (1) to determine the June 2020 prevalence of infection and serostatus for SARS-CoV-2 in the population of Blaine County, Idaho and (2) to determine the September 2020 serostatus for SARS-CoV-2 in the population of Blaine County, Idaho. The secondary objective is to determine genomic sequences of PCR-confirmed cases of SARS-CoV-2.Study seeks to enroll 10,000 men and women in Blaine Count, Idaho, who will be sampled by standard methods for SARS-CoV-2 by PCR testing, and for anti-SARS-CoV-2 antibodies by blood draw and serologic testing. Participants are eligible if they are current full-time or part-time resident of Blaine County, Idaho and are willing and able to provide informed consent. Testing performed at UW Virology Laboratory.
Immunometabolic Assessment of ICU COVID-19 PatientsObservationalRong TianThe proposed study is a pilot to assess the yield of leukocyte subpopulation isolation and leukocyte response to in vitro NR treatment. Aim 1: Assess the mitochondrial function in circulating monocytes, T lymphocytes, and B lymphocytes of patients with symptomatic COVID-19 patients and seek the relationship between immunometabolism and the clinical outcomes. Aim 2: Determine the effect of boosting PBMC NAD by in vitro NR treatment on cytokine production and NAD metabolome.Plan to enroll 5 adult hospitalized COVID-19 positive patients with signs and symptoms consistent with respiratory failure and 5 age (+/- 3 years) /gender/ethnicity/risk factor-matched control subjects. A one-time blood sample (25 ml) will be collected from all subjects.
Large Vessel Strokes: COVID-19 Trends in the WWAMI RegionObservationalMelanie WalkerElectronic survey to providers/institutions to learn about trends related to stroke during COVID-19 pandemic. Information learned will be shared between institutions across 5-state region.Lead administrator for all state and nationally certified thrombectomy-capable stroke centers in the WWAMI region.
COVID-19 Pregnancy Experiences: COPEObservationalAmritha Bhat1. Determine mental health symptoms, labor and delivery experiences (e.g., duration of separation, length of hospital stay, lack of support persons) and attachment among mothers who were SARSCoV+ during pregnancy / delivery. 2. Explore breastfeeding rates among infants born to mothers who were SARSCoV+ during pregnancy / delivery. 3. Determine developmental outcomes within motor, social, cognitive, and language domains within the first year of life among infants born to mothers who were SARSCoV+ during pregnancy / delivery.COVID+ mothers recruited into the Pregnancy Collaborative. The WA State pregnancy collaborative has 90 mothers enrolled so far. Also seek to conduct 20-25 qualitative interviews. No final n specified.
Characterizing SARS-CoV-2-specific immunity in convalescent individuals, HVTN 405/HPTN 1901)ObservationalJanine MaenzaTo identify serologic reactivities that differentiate SARS-CoV-2 infection from vaccination; to develop and formally qualify a suite of immunologic assays and reference reagents that permit detailed interrogations of the immune response to SARS-CoV-2 infection in preparation for similar assessments of vaccine-elicted immune responses; to measure SARS-CoV-2 specific adaptive immune responses to identify immune markers of COVID-19 disease severity and duration in different demographic groups and in people with different medical histories; to characterize presentations of SARS-CoV-2 infection, including the clinical course of COVId-19, among convalescent individuals400 individuals recovered from COVID-19 across North and South America. Locally, anticipate enrolling 10-20 participants across all groups described in protocol: persons with prior asymptomatic COVID-19, ages 18-55; persons with prior asymptomatic COVID-19, age >55; persons with prior symptomatic COVID-19, not hospitalized, ages 18-55; persons with prior symptomatic COVID-19, not hospitalized, age >55; persons perviously hospitalized for COVID-19, ages 18-55; persons perviously hospitalized for COVID-19, age >55; persons with specific clinical spectrums or outcomes of COVID-19, regardless of hospitalization history.
Test validation for detection of SARS-CoV-2 in salivaObservationalLori BourassaWe seek to perform a test validation to determine if saliva is an acceptable specimen type for SARS-CoV-2 testing. The validation will be performed in the Department of Laboratory Medicine in the Division of Virology. For this study, paired nasopharyngeal and saliva samples collected from confirmed COVID-19 positive inpatients within UW Medicine and patients under investigation for COVID-19 will be tested to determine if saliva demonstrates acceptable clinical performance as a sample type for the detection of SARS-CoV-2.Paired nasopharyngeal and saliva samples collected from confirmed COVID-19 positive inpatients within UW Medicine and samples collected from patients under investigation for COVID-19 will be tested to determine if saliva demonstrates acceptable clinical performance as a sample type for the detection of SARS-CoV-2. Thirty paired, positive nasopharyngeal samples and 30 saliva samples will be compared. In addition, 30 paired, negative nasopharyngeal samples and 30 saliva samples will be compared.
Feasibility of focused cardiac and lung ultrasound with auto-ejection fraction in Emergency Department and Intensive Care Unit patients with COVIDObservationalSachita ShahAim 1: Compare the efficiency and quality of echocardiograms obtained with and without Navigational Guidance and Auto-EF in the Emergency Department faced with COVID. Aim 2: Describe the longitudinal pattern of ejection fraction in critically ill patients with COVID admitted to an intensive care unit. Aim 3: Evaluate the frontline provider experience of integrating AI-assisted echocardiography into the Intensive Care Unit. Aim 4: Develop a risk prediction score that integrates ejection fraction at presentation to improve triage of patients presenting with suspected COVID.Emergency Department Cohort: 50-100 intubated patients, 18 or older, with suspected or confirmed COVID. Intensive Care Cohort: 25 patients, 18 years or older, with confirmed COVID and admitted to ICU. Additional Risk Prediction Cohort: At least 300 patients recruited from centers across US will be invited to contribute anonymized demographic and clinical data on patients with confirmed COVID infection who had an echocardiogram within the first 24 hours of presentation.
Identifying and mitigating the burden of psychological distress among family members of patients with critical illness from COVID-19 [COVID-19 Family Impact Study]ObservationalJ. Randall CurtisThis supplemental study will identify factors associated with burdensome psychological symptoms among a unique and previously unexamined population: family members of critically ill patients with COVID-19. Before the COVID-19 pandemic, studies demonstrated that many family members of critically ill patients suffered from psychological distress as a result of their loved one’s critical illness and ICU treatment. In the current circumstances, visitation restrictions are likely to augment and complicate families’ experiences of distress. We will conduct a mixed-method, observational cohort study with longitudinal assessments (3-6-12 months) to identify the burden of psychological distress experienced by family members over time following their loved one’s critical illness from COVID-19, as well as the modifiable and non-modifiable predictors of this distress.Eligible patients over 55 will be identified by EHR automatic daily screening of hospitalized patients screening for: admission for minimum of 12 hours/maximum of 96 hours to participating in-patient services, without documentation in the EHR of a goals-of-care discussion during the current hospital admission, and meet criteria for serious illness, encompassing multiple acute and chronic illnesses, including: those used by the Dartmouth Atlas21 to study end-of-life care in the US (malignant cancer/leukemia, chronic pulmonary disease, coronary artery disease, congestive heart failure, chronic liver disease, chronic renal disease, dementia, diabetes with end-organ damage, and peripheral vascular disease); and, COVID-19. To increase inclusivity of important and under-studied populations, we will also include as eligible all hospitalized patients over age 80.
Between Scylla and Charybdis: Navigating Care for Cancer Patients with COVID-19 and their Family MembersQualitativeElizabeth LoggersThe goal of this research is to foster innovation in patient and family-centered approaches to healthcare during respiratory pandemic, including COVID-19, while simultaneously protecting individual and public health. We hypothesize that: (1) Survivors and family members will describe the difficulty of not being in physical contact during active COVID-19 infection due to healthcare policies and processes; (2) Survivors and family members will note difficulties in communication with the clinical team; (3) Clinicians will describe the difficulty of enforcing visitor restrictions and communicating the care plan to patients and family members, including at the end of life; (4) All subjects will have recommendations for improving healthcare to make it more patient and family-centeredWashington state cancer patients with COVID-19 infection (both living and dead). Will conduct interviews of cancer patients whp have survived COVID-19 infection. Will attempt to recruit up to 10 survivors, 60 family members, and 90 clinicians.
CoVPN 5001: A prospective study of acute immune responses to SARS-CoV-2 infectionObservationalJanine MaenzaObjective 1: To generate standardized datasets characterizing the quality, magnitude, and kinetics of humoral immune responses to SARS-CoV-2 infection in asymptomatic participants and symptomatic participants (both hospitalized and non-hospitalized) experiencing a range of clinical outcomes in order to prepare for similar assessments during trials of immune-based preventive strategies. Objective 2: To characterize innate and cellular immune responses to SARS-CoV-2 infection during infection with SARS-CoV-2 in asymptomatic and acutely symptomatic participants.Across 63 multi-national sites, the protocol is designed to enroll 800 participants. 220 persons that are PCR positive for SARS-CoV-2 and are asymptomatic; 460 persons that are PCR positive for SARS-CoV-2 with recent onset of mild symptoms (not hospitalized); 120 persons that are PCR positive for SARS-CoV-2 and are symptomatic hospitalized patients. This site anticipates enrolling 5-10 of these participants.
Seattle COVID-19 Cohort Study to Evaluate Immune Responses in Persons at Risk and with SARS-CoV-2 InfectionObservationalJanine Maenza1. To determine early immune events and host factors associated with SARS-CoV-2 infection in persons with and without sings and symptoms of infection; 2. To determine the specificities, kinetics, titer, and duration of binding and neutralizing antibodies in persons with asymptomatic infection in contrast to those with mild to moderate COVID-19; 3. To determine the specificity and function of SARS-CoV-2 specific memory CD4+ and CD8+ T cells post-infection.Not anticipated to exceed 1,000 subjects. Individuals aged 18 and up with a known COVID-19 diagnosis or at risk for SARS-CoV-2 infection. This application focuses on individuals with a known COVID-19 diagnosis at any point in time who are not hospitalized at the time of enrollment.
Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID) (ACTIV-2/A5401)InterventionalAnn CollierTo evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19. The first agent to be studied is LY3819253. The trial is a randomized, blinded, controlled adaptive platform that llows agents to be added and dropped for efficient testing of new agents against placebo within the same trial infrastructure.Sympomatic non-hospitalized adults with COVID-19. An anticipated 110 participants will receive LY3819253 and 110 will receive placebo.
Seattle Mother-Infant COVID-19 StudyObservationalMelanie MartinStudy aims to assess breastfed infant COVID-19 infection risks following the resolution of maternal infection, and the context of risks to other family members or exposures. Study aims to examine infection and immune responses within and between mother-infant dyads and household family members in the 2 months following confirmed maternal infection. Hypothesize that (1) maternal SARS-CoV-2 infection represents a potential mode of vertical transmission via human milk (since other viruses are present in milk and SARS-CoV-2 RNA has been identified in milk produced by some infected women; however, (2) maternal SARS-CoV-2 infection may also increase protective factors in milk such that breastfeeding may be associated with reduce infant infection and/or morbidity risks.Across sites, recruiting 25 breastfeeding and 25 non-breastfeeding mother-infant dyads. Expect to recruit 10-20 mothers from greater Seattle area for multi-site study. Mothers must be at least 18 years of age, diagnosed with COVID-19 in last 7 days, and have a child 0-24 months of age.
Nasal immunity to SARS-CoV-2ObservationalDavid KoelleHypotheses: SARS-CoV-2 immune persons will have detectable IgG and IgA in NELF specific for SARS-CoV-2 when sampled ~ 6 months after recovery from COVID-19. SARS-CoV-2 immune persons will have detectable SARS-CoV-2-specific T cells in the nasal mucosa when sample ~ 6 months after recovery from COVID-19. The levels of nasal T cells will be higher than in blood, reflecting the presence of tissue resident memory T cells (TRM) at the portal for possible future re-infection. SARS-CoV-2 immune persons will have higher levels of SARSCoV-2-specific antibodies and T cells than SARS-CoV-2 seronegative controls, despite the circulation of seasonal coronaviruses with antigenic relatednessWe will study 10 persons COVID-19 cases and 4 SARS-CoV-2 seronegative controls. Subjects will be recruited from UW Virology Research Clinic. Patient characteristic entry criteria will be documented seropositivity for SARS-CoV-2, age >18, and interest in participation. Will prefer subjects with high antibody levels. Controls will be healthy adults seronegative for SARS-CoV-2.
NCICOVID: NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History StudyObservationalMargaret MadeleineObjectives: 1. Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. 2. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. 3. Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinical and pathologic characteristics. 4. Collect longitudinal blood samples to evaluate SARS-CoV-2 antibody development, cytokine abnormalities, and genetic polymorphisms associated with severe COVID-19 5. Create a national data repository of clinical data, research blood specimens, and radiologic images for future research.This natural history study nationwide will enroll up to 2,000 patients with both confirmed COVID-19 and cancer for which they have received treatment and to follow them for up to 2 years. Locally we plan to enroll 20-30 patients over 2 years. Study eligibility: Patients undergoing active treatment for stage I-III or metastatic cancer (within past 6 weeks), allogenic
SCT (any time), CAR-T cell or other cellular therapy (anytime), or active treatment or prophylaxis for GVD, or autologous BMT within past 2 years; incident SARS-CoV-2 infection within 14 days prior to enrollment
Phase 2 Vaccine for COVID-19 preventionInterventionalScott McClellandThe primary objective of this trial is to estimate the efficacy of 2 IM doses of the investigational vaccine compared to placebo for the prevention of COVID-19 in adults. The efficacy endpoint is a binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs ≥ 15 days post second dose of study intervention. Other important endpoints include incidence of AE’s for 28 days post each dose of study product; incidence of SAEs, MAAEs, and AESIs from Day 1 posttreatment through Day 730; reactogenicity of 2 IM
doses of study product; Incidence of local and systemic solicited AEs for 7 days post each dose of study intervention.
Patients will be adults 18 years and older who are healthy or have medically-stable chronic diseases, and are at increased risk for SARS-CoV-2 acquisition and COVID-19. Approximately 30,000 participants will be randomized in a 2:1 ratio to receive 2 IM doses of vaccine or saline placebo.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2InterventionalRuanne BarnabasFor analysis of endpoints, there are 2 defined cohorts based on the subjects' SARS-CoV-2 infection status at baseline, as measured by central lab SARS-CoV-2 RT-qPRC (quantitative reverse transcription polymerase chain reaction): negative (cohort A) or positive (cohort B). Cohort A primary objectives: To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (strict-term) confirmed by RT-qPCR; to evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing asymptomatic or symptomatic SARS-CoV-2 infection confirmed by RT-qPCR; to evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo.Cohort A: approximately 1700 adult subjects with a negative rapid SARS-CoV-2 RT-PCR at baseline. Cohort B: approximately 300 adult subjects with a positive rapid SARS-CoV-2 RT-PCR at baseline will be enrolled. Target population: asymptomatic, healthy adults who are household contacts to an individual with a positive SARS-CoV-2 RT-PCR assay.
“Antithrombotic Therapy to Ameliorate Complications of COVID-19InterventionalManoj MenonThis study aims to evaluate the efficacy of therapeutic-dose parenteral heparin versus usual care in hospitalized COVID-19 patients. We hypothesize that therapeutic-dose heparin reduces intubation and mortality by 30 days after initiation of therapy. Primary endpoint is an ordered categorical endpoint with 3 possible outcomes based on the worst status of each patient through day 30 following randomization: no invasive mechanical ventilation, invasive mechanical ventilation, or death. Secondary objectives include determination of the safety and efficacy of therapeutic-dose parenteral anticoagulation.Patients 18 years of age and older providing informed consent who require hospitalization anticipated to last 72 hours or more, with microbiologically-confirmed COVID-19, enrolled less than 72 hours of hospital admission or of COVID-19 confirmation.
Therapeutics for Inpatients with COVID-19InterventionalNick JohnsonTherapeutics for Inpatients with COVID-19 (TICO) is a protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or directly enhancing viral control in order to limit disease progression.Stage 1 (Phase IIb): hospitalized with COVID-19, symptoms <=12 days, without end organ failure or dysfunction. Sample size for one (two) agents introduced together: 300 (or 450. Stage 2 (Phase III): hospitalized with COVID-19, symptoms <= 12 days, with or without end organ failure or dysfunction. Sample size: 1,000 (or 1,500). This includes 300 (450) from stage 10.
Passive Immunity Trial for Our Nation (PassItOn)InterventionalNick JohnsonPassItOn will compare the effect of convalescent plasma versus placebo on clinical outcomes, measured by an ordinal clinical progression outcomes scale among adults with COVID-19 requiring hospitalization. The primary outcome classifies patients on day 15 with respect to hospitalization, physical limitations, and use of supplemental oxygen.Participants with lab-confirmed SARS-CoV-2 infection within the preceding 14 days, and who are currently hospitalized or in the emergency department waiting for hospital admission. Participants must have respiratory symptoms and be willing to receive full supportive care, except for attempts at resuscitation from cardiac arrest. Consent materials provided in English, Spanish, and Arabic. Pregnant women are eligible.
Observational biopsy study of the persistence of nasopharyngeal and systemic SARS-CoV-2-specific cellular and humoral immunity in survivors of COVID-19 requiring hospitalization versus not requiring hospitalizationObservationalDavid KoelleSARS-CoV-2 immune persons will have detectable IgG and IgA in NELF specific for SARS-CoV-2 when sampled ~6 weeks, 6 months, and 1 year after recovery from COVID-19. SARS-CoV-2 immune persons will have detectable SARS-CoV-2 specific T cells in the nasal mucosa when sampled ~6 weeks and 1 year after recovery. The levels of nasal T cells will be higher than in blood, reflecting the presence T-rm at the portal for possible future re-infection. Severity analysis will show that hospitalized persons will have higher levels of nasal T-rm and antibodies than non-hospitalized patients.We will study 32 persons COVID-19 cases and no controls. Cases will be 16 persons requiring hospitalization for COVID-19 symptoms and 16 not.
Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Anti-CD14 Treatment in Hospitalized Patients with COVID-19 (DAIT-COVID-19-003); The COVID-19 anti-CD14 Treatment Trial (CaTT)InterventionalMark WurfelPrimary objective is to determine whether IC14 treatment in patients hospitalized with respiratory disease and hypoxemia due to SARS-CoV-2 is efficacious in terms of improving the time to resolution of disease using the Eight-Pont ordinal scale. Secondary objectives include determining the efficacy of IC14 in reducing the severity of respiratory disease in patients hospitalized with COVID-19 and determining the safety of IC14 in patients hospitalized with respiratory disease due to SARS-CoV-2.Patients w/SARS-COV-2 infection confirmed by RT-PCR within 7 days of screenings. Patients with radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection. Patients with hypoxemia as defined by any of the following: SpO2< or equal to 94% on room air, or requirements for > or equal to 2L/m O2 per standard nasal cannula to maintain SpO2< or equal to 94%, but not requiring high-flow nasal cannula (defined as > or equal to 30 L/m). Negative pregnancy tests for women of childbearing age.
COVID-19 prevalence, household transmission, and antibody response among pregnant women and household members in WA stateObservationalAlison Drake1) Measure seroprevalence and cumulative incidence, and co-factors of SARS-CoV-2 infection, including previously undetected asymptomatic, mild, and recovered COVID-19 during pregnancy.
2) Determine SARS-CoV-2 impact on maternal, pregnancy, and infant outcomes.
3) Estimate potential household transmission and durability of SARS-CoV-2 specific IgG antibody response among pregnant women (IgG+ index cases) and their pediatric and adult household
contacts based on longitudinally collected blood samples.
4) Characterize SARS-CoV-2 antibody profiles among maternal-infant pairs, including functional status of maternal and neonate IgG, transplacental transfer of maternal IgG to neonates, and durability of maternally derived IgG in mothers and infants.
Will test residual plasma samples for SARS-CoV-2 IgG collected from 1,000 pregnant women from routine blood work, as well as prospectively enroll pregnant women. Will also conduct a nested cased control study among IgG+ pregnant index cases and 2 IgG-controls per index case to participate in epidemiological survey to compare risk factors for maternal infection and household transmission
Assessing the Inflammatory Cytokine Profile among Recipients of Convalescent Plasma in the Treatment of COVID-19ObservationalManoj MenonTo describe the inflammatory cytokine profile in up to 50 patients with severe COVID-19 who receive convalescent plasma; to describe the kinetics of inflammatory cytokines in up to 50 patients with COVID-19 who receive convalescent plasma and determine association with neutralizing antibody titersPatients with severe COVID-19 who receive convalescent plasma.
Severe Acute Respiratory Illness – Program for Emergency Preparedness (SARI-PREP); a multi-institutional observational consortium for study of hospitalized COVID-19 and other severe epidemic/pandemic respiratory illness.ObservationalMark WurfelPatient characteristics such as race/ethnicity, age, gender, co‐morbidities, and outpatient medications are associated
with risk for respiratory failure and death in patients admitted with viral SARI such as COVID‐19 and influenza.
Admission to acute care or intensive care unit with a clinical syndrome of lower respiratory tract infection suspicious for viral SARI. This will be defined by the presence of fever, cough, AND (radiographic infiltrates by imaging (chest x‐ray, CT scan, etc.), OR SpO2 ≤ 94% on room air OR requiring new supplemental oxygen (above baseline if preexisting) OR requiring invasive or non‐invasive mechanical ventilation). SARS‐CoV‐2 infection confirmed by RT‐PCR within 7 days of screening.
A Phase 1 Study of DVX201, an Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19InterventionalJoshua HillInfusion of allogeneic NK cells will be safe and will restore the functional innate immune response resulting in NK mediated cytolysis of virally infected cells, thereby reducing viral load and preventing progression of disease. The primary objective is to investigate the safety and to identify the recommended Phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of DVX201, an allogeneic NK cell therapy, in patients hospitalized with COVID-19.Subjects must be between 18 and 80 years of age, require hospitalization, and be confirmed positive for SARS-CoV-2 by validated clinical PCR assay within 7 days of consent. There must be radiographic infiltrates by imaging (CXR, CT scan). Subject can be on supplemental oxygen up to 4L by low flow O2-delivery as needed to maintain SpO2 ≥ 93%. Inflammatory markers must be low: IL-6 < 150 pg/mL OR CRP < 100 mg/L (10 mg/dL) OR Ferritin < 1000 ng/mL. FDA approved antiviral medications are allowed.
Nicotinamide Riboside in SARS-CoV-2 patients for Renal ProtectionInterventionalPavan BhatrajuPrimary objectives are 1) to determine the effect of nicotinamide riboside (NR) on whole blood NAD+ levels in hospitalized patients with COVID-19 infection and AKI and 2) to evaluate the safety of NR in patients with COVID-19 infection and AKI. Secondary objectives include measures of efficacy in clinical outcomes, such as a decrease in serum creatinine concentrations and lower rates of AKI.Participants will be >18 years old and admitted to hospital with a laboratory diagnosis of COVID-19 infection and AKI and persistent AKI (defined as an elevation of ≥ 0.3 mg/dL in serum creatinine concentrations from hospital presentation and a persistent elevation for at least one day). We chose specifically to enroll patients with established AKI as the majority of COVID-19 patients with AKI present to the hospital with kidney injury rather than develop kidney injury during hospitalization. Moreover, biologically NAD supplementation has been suggested to enhance kidney recovery rather than prevent kidney injury
PReventing Emerging Infections through Vaccine EffectiveNess Testing (PREVENT) ProjectObservationalDaniel HenningTo evaluate post-introduction effectiveness of a complete schedule of SARS-CoV-2 vaccine in preventing laboratory-confirmed symptomatic COVID-19 among health care workers.Any health care worker tested across the UW system will be eligible for inclusion. Criteria 1: At least one of the following respiratory signs/symptoms: shortness of breath or difficulty breathing; cough; or severe respiratory illness with either clinical or radiographical evidence of pneumonia or acute respiratory distress syndrome (ARDS). Criteria 2: At least two of the following signs/symptoms: fever (within episode of illness); myalgia; new olfactory and taste disorder(s); chills; rigors; headache; sore throat.
o A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults with COVID-19TreatmentElizabeth Dukeo This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. This study will enroll adults who have recently tested positive for SARS-COV-2 and have experienced at least one related mild or moderate symptom. Patients between the ages of 18-59 must have at least one pre-existing risk factor to be eligible.o Individuals ≥18 years of age with documented SARS-CoV-2 (COVID-19) infection and have experienced at least one related mild or moderate symptom within the past 5 days. Patients between the ages of 18-59 must have at least one pre-existing risk factor to be eligible.
A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patientsTreatmentAdrienne Shapiro, MDThis is a phase 3 study that will compare the administration route of an intramuscular shot to IV infusion of sotrovimab, a monoclonal antibody with FDA emergency use authorization for the early treatment of non-hospitalized patients with COVID-19. This study will enroll individuals ages 12 years-or-older who have recently tested positive for SARS-COV-2 and have experienced at least one related symptom within 7 days of enrollment. There will be no placebo use, individuals who have already received the COVID-19 vaccine may still be eligible, and participants between the ages of 12-54 must have at least one pre-existing risk factor in order to be eligible.Adults 18 years of age or older at the time of signing the informed consent

o Laboratory confirmed SARS-CoV-2 infection, with test results within past 7 days

o Symptomatic – experiencing at least one of the following symptoms within past 7 days: fever/chills, tiredness/fatigue, headache, muscle/body aches, cough, sore throat, shortness of breath upon exertion, stuffy or runny nose, loss of smell or taste, nausea or throwing up, diarrhea

o If 12-54 years of age, has secondary risk factor of: diabetes (requiring medication), obesity (BMI > 30 or > 85th percentile for age/gender), chronic kidney disease, chronic liver disease, chronic obstructive pulmonary disease (COPD), congestive heart failure (NYHA class II or more) or congenital heart disease, history of lung disease (pulmonary hypertension, cystic fibrosis, idiopathic pulmonary fibrosis, pulmonary fibrosis, sarcoidosis, respiratory distress syndrome, pulmonary edema, obstructive lung disease), moderate-severe asthma (requiring inhaled or oral steroid treatment current/within past year), neurodevelopmental disorders, sickle cell disease, immunosuppressive disease or immunosuppressive medications (recent solid organ or blood stem cell transplant recipients, cancer patients on chemotherapy, patients on medication for active malignancy, HIV patients, Autoimmune disease patients on biologics/etc)

o If 55+ years of age, no secondary risk factor required

o Individuals who have received the COVID-19 vaccine are still eligible to participate