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

• Status: Active, not recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Azithromycin; Hydroxychloroquine

Criteria

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)