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Current UW COVID-19 Clinical Research

Current UW COVID-19 Clinical Research

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

Study TitleCategoryPrincipal InvestigatorDescriptionStudy PopulationPrimary ContactExternal Sponsor
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 dischargePavan BhatrajuN/A
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 HMCKirsten HaugeNIAID
Effect of post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: A open-label, randomized study of hydroxychloroquine among adults exposed to coronavirus disease (COVID-19)PreventionRuanne BarnabasTest the efficacy of hydroxychloroquine to prevent incident severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection. Adults aged 18-80 without COVID-19 signs or symtpoms who have been exposed to COVID-19Meighan KrowsBill and Melinda Gates Foundation
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-19Jenni LogueDARPA
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 infectionsIzzy BrandstetterBrotman Baty Institute
INSPIRE Registry Clinical Epidemiology, Treatment Graham Nichol,
Matthew J. Thompson
This 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 Karen Adamsn/a
Convalescent plasma as therapy for COVID-19 infectionTreatment, PreventionAnna Wald To 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 healthAnna Waldn/a
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"Chenee Holcomb n/a
Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform TrialTherapeutic or Preventative Clincial TrialChristine JohnstonRandomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of lopinavir/ritonavir for the treatment of SARS-CoV-2 infection in high risk adults not requiring hospital admission. Men and women 18 to 80 years of age who test positive for SARS-CoV-2 within the past 72 hoursStudy emailBill and Melinda Gates Foundation
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.Rachel Bender IgnacioNovartis
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.Vickie RamirezAmerican Endowment Foundation
Wild Lives Foundation
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.Rachel Bender Ignacio, MD, MPH Novartis
PETAL COVID-19 Observational StudyObservationalTerri HoughRED CORAL - retrospective data collection
BLUE CORAL - prospective data and specimen collection
RED: 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
Stephanie Gundel NHLBI/PETAL Network
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-19Stephanie Gundel NHLBI/PETAL Network
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).Sasha Tillles
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.Dave LuNorthern New England Clinical and Translational Research (NNE-CTR)
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-19TreatmentMichael BoeckThis 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) adults with COVID-19, including symptomatic and asymptomatic patients with SARS-CoV-2 infection.Individuals ≥18 years of age with virologically documented SARS-CoV-2 infection tested ≤72 hours prior. Participants may be either without symptoms at time of enrollment OR with onset of symptoms consistent with COVID-19 ≤7 days at time of enrollment.Jennifer HanRegeneron Pharmaceuticals, Inc.
A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient SettingTreatmentJoshua A. HillThe trial is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate treatment with intravenous (IV) administered Remdesivir (RDV, GS-5734) in an outpatient setting in participants with confirmed coronavirus disease 2019 (COVID-19) who are at risk for disease progression.Virologically documented SARS-CoV-2 infection within past 4 days; 18 years or older with pre-existing risk factors for progression or 60 years or older regardless of other pre-existing risk factorsRachel Blazevic Gilead Sciences, Inc.
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of EIDD-2801 to Eliminate SARS-CoV-2 Viral RNA Detection in Persons with COVID-19TreatmentMichael BoeckThis is a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 versus placebo as measured by infectious virus detection in symptomatic adult outpatients with COVID-19. Individuals ≥18 years of age with virologically documented SARS-CoV-2 infection within the past 4 days. Participants must have onset of symptoms consistent with COVID-19, including fever, chills, upper respiratory congestion, lower respiratory congestion, or loss of sense of smell or taste, within 7 days of enrollment.Marta LevkovaRidgeback Biotherapeutics, LP