Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19

002011

This is a three-arm randomized trial comparing the efficacy of single agent hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of treatment in order to determine which regimen is more effective.

2020-04-01

2020-10-14

2020-10-14

Terminated

Early phase I

75

Inclusion Criteria: * Patients with proven SARS-CoV-2 infection by an accepted assay with symptoms consistent with COVID-19 * Ability to measure and quantify viral load by quantitative PCR * Age 18 to 89 * Ability to swallow oral medications * Patients must read, understand and sign IRB approved informed consent Exclusion Criteria: * Pregnancy or women who are breast feeding * Two consecutive negative assays for SARS-CoV-2 infection * Patients that lack decision-making capacity will not be approached to participate in this study * Inability to tolerate oral medications * Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate * QTc interval \> 470 mSEC * History of ongoing ventricular cardiac dysrhythmias of grade 2 as described by NCI CTCAE 5.0 criteria * History of serious ventricular arrhythmia (VT or VF \> 3 beats in a row)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}

2023-02-28