Status:
TERMINATED
Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection
Lead Sponsor:
Duke University
Conditions:
SARS-CoV-2
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04335552
Start Date
April 17 2020
End Date
June 26 2020
Last Update
May 17 2021
Active Locations (4)
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1
Duke Regional Hospital
Durham, North Carolina, United States, 27704
2
Duke University Hospital
Durham, North Carolina, United States, 27710
3
Durham VA Medical Center
Durham, North Carolina, United States, 27710
4
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609