Status:
TERMINATED
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
SARS-CoV-2
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, w...
Detailed Description
PRIMARY OBJECTIVE: I. Determine change in viral load at day 6 compared to baseline between two regimens to treat COVID-19 and a contemporaneous control group. SECONDARY OBJECTIVES: I. Time to resol...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2020
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04336332
Start Date
April 1 2020
End Date
October 14 2020
Last Update
February 28 2023
Active Locations (5)
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1
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
2
Robert Wood Johnson University Hopsital
New Brunswick, New Jersey, United States, 08901
3
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
4
The University Hospital
Newark, New Jersey, United States, 07103