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Status:

TERMINATED

Treatment for COVID-19 in High-Risk Adult Outpatients

Lead Sponsor:

University of Washington

Collaborating Sponsors:

Bill and Melinda Gates Foundation

Conditions:

COVID-19

SARS-CoV-2

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

PHASE3

Brief Summary

This is a randomized trial for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in high-risk adults not requiring hospital admission.The overarching goal of this...

Detailed Description

This is a randomized, multi-center, placebo-equivalent (ascorbic acid + folic acid)-controlled, blinded platform trial. Eligible participants will be enrolled and randomized to Hydrocychloroquine (HCQ...

Eligibility Criteria

Inclusion

  • Men or women 18 to 80 years of age, inclusive, at the time of signing the informed consent
  • Willing and able to provide informed consent
  • Laboratory confirmed SARS-CoV-2 infection, with test results within past 72 hours
  • COVID-19 symptoms, based on the following criteria: At least TWO of the following symptoms: Fever (≥ 38ºC), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s), OR o At least ONE of the following symptoms: cough, shortness of breath or difficulty breathing (Lopinavir-Ritonavir Platform)
  • Access to device and internet for Telehealth visits
  • At increased risk of developing severe COVID-19 disease (at least one of the following)
  • Age ≥60 years
  • Presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, emphysema
  • Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment
  • Hypertension, requiring at least 1 oral medication for treatment
  • Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus with a CD4 T-cell count of \<200/mm3)
  • Immunocompromised status due to medication (e.g., persons taking 20 mg or more of prednisone equivalents a day, anti-inflammatory monoclonal antibody therapies, or cancer therapies)
  • Body mass index ≥30 (self-reported)

Exclusion

  • Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
  • Known hypersensitivity to azithromycin or other azalide or macrolide antibiotics
  • Currently hospitalized
  • Signs of respiratory distress prior to randomization, including respiratory rate \>24
  • Current medications include HCQ
  • Concomitant use of other anti-malarial treatment or chemoprophylaxis
  • History of retinopathy of any etiology
  • Psoriasis
  • Porphyria
  • Chronic kidney disease (Stage IV or receiving dialysis)
  • Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes \<1500) or thrombocytopenia (\<100 K)
  • Concomitant use of digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen
  • Known cirrhosis
  • Known personal or family history of long QT syndrome
  • History of coronary artery disease with a history of graft or stent
  • History of heart failure, Class 2 or greater using the New York Heart Association functional class
  • Taking medications associated with prolonged QT and known risk of torsades de points. These medications may include some antipsychotic and antidepressant medications. (Lopinavir-Ritonavir Platform)
  • Taking medications associated with prolonged QT such as antipsychotic medications or antidepressants (e.g., citalopram, venlafaxine, and bupropion) and unable to stop during the trial
  • Taking warfarin (Coumadin or Jantoven)
  • Known history of glucose-6-phosphate-dehydrogenase deficiency
  • History of myasthenia gravis

Key Trial Info

Start Date :

April 16 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 30 2020

Estimated Enrollment :

289 Patients enrolled

Trial Details

Trial ID

NCT04354428

Start Date

April 16 2020

End Date

November 30 2020

Last Update

August 8 2022

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Ruth M. Rothstein CORE Center - Cook County Health

Chicago, Illinois, United States, 60612

2

Tulane University

New Orleans, Louisiana, United States, 70118

3

Boston University

Boston, Massachusetts, United States, 02215

4

SUNY Upstate Medical University

Syracuse, New York, United States, 13210