Treatment for COVID-19 in High-Risk Adult Outpatients

• Status: Active, not recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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 study is to assess the effectiveness of interventions on the incidence of lower respiratory tract infection (LRTI) progression among high-risk adult outpatients with SARS-CoV-2 infection to inform public health control strategies.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborator: Bill and Melinda Gates Foundation
• Treatments: Ascorbic Acid; Azithromycin; Folic Acid; Hydroxychloroquine; Lopinavir; Ritonavir; Vitamin B Complex

Criteria

Inclusion Criteria:

• 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)

1. Age ≥60 years

2. Presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, emphysema

3. Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment

4. Hypertension, requiring at least 1 oral medication for treatment

5. Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus with a CD4 T-cell count of <200/mm3)

6. 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)

7. Body mass index ≥30 (self-reported)

Exclusion Criteria:

• 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