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Purpose

This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Admitted to participating hospital with symptoms suggestive of COVID-19 infection OR develop symptoms of COVID-19 during hospitalization 2. Subject (or legally authorized representative) can provide written informed consent (in English or Spanish) affirming intention to comply with planned study procedures prior to enrollment 3. Male or female adult aged 12 years or older at the time of enrollment 4. Has laboratory-confirmed SARS-CoV-2 infection determined by a validated nucleic acid amplification assay (public health or commercial) in any respiratory specimen collected within 14 days of randomization 5. Illness of any duration that includes - Radiographic evidence of pulmonary infiltrates (chest X-ray or CT scan) OR - Clinical documentation of lower respiratory symptoms (cough, shortness of breath, wheezing) OR - Any documented SpO2 ≤ 94% on room air OR - Any inpatient initiation or supplemental oxygen regardless of documented cause

Exclusion Criteria

  1. Participating in any other clinical trial of an experimental agent for COVID-19 2. On hydroxychloroquine at any time during hospitalization, or within 180 days of hospitalization for COVID-19 regardless of indication 3. History of G6PD deficiency, cirrhosis, long QT syndrome or porphyria of any classification 4. Most recent ECG prior to time of screening with QTc of ≥500 msec 5. Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives 6. Death anticipated within 48 hours of enrollment 7. Inability to obtain informed consent from the patient or designated medical decision maker

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
Patients will be initially randomized to one of two arms in a 1:1 ratio: 1) Standard of care treatment or 2) Standard of care treatment plus 5 days of hydroxychloroquine. Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard of care
  • Other: Standard of care
    Standard of care
Experimental
Standard of care plus hydroxychloroquine 		Standard of care plus hydroxychloroquine for 5 days
  • Other: Standard of care
    Standard of care
  • Drug: Hydroxychloroquine
    Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5
Experimental
Standard of care plus azithromycin 		Standard of care plus azithromycin for 5 days
  • Other: Standard of care
    Standard of care
  • Drug: Azithromycin
    Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5
Experimental
Standard of care plus hydroxychloroquine plus azithromycin 		Standard of care plus hydroxychloroquine plus azithromycin for 5 days
  • Other: Standard of care
    Standard of care
  • Drug: Hydroxychloroquine
    Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5
  • Drug: Azithromycin
    Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5

Recruiting Locations

More Details

NCT ID
NCT04335552
Status
Terminated
Sponsor
Duke University

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.