Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection
Stopped early · Phase 2
Conditions studied: SARS-CoV-2
In brief
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
Key facts
- Study ID
- NCT04335552
- Run by
- Duke University
- People needed
- 11
- Starts
- 2020-04-17
- Expected to finish
- 2020-06-26
- Last updated by the study team
- 2021-05-17
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Admitted to participating hospital with symptoms suggestive of COVID-19 infection OR develop symptoms of COVID-19 during hospitalization
- 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
- Male or female adult aged 12 years or older at the time of enrollment
- 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
- 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
You may not qualify if…
- Participating in any other clinical trial of an experimental agent for COVID-19
- On hydroxychloroquine at any time during hospitalization, or within 180 days of hospitalization for COVID-19 regardless of indication
- History of G6PD deficiency, cirrhosis, long QT syndrome or porphyria of any classification
- Most recent ECG prior to time of screening with QTc of ≥500 msec
- Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
- Death anticipated within 48 hours of enrollment
- Inability to obtain informed consent from the patient or designated medical decision maker
Where it is running
- Duke Regional Hospital — Durham, North Carolina, United States
- Duke University Hospital — Durham, North Carolina, United States
- Durham VA Medical Center — Durham, North Carolina, United States
- Duke Raleigh Hospital — Raleigh, North Carolina, United States
Full record on ClinicalTrials.gov
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