Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 75
- Locations
- 5
- Primary Endpoint
- Changes in Patients Viral Load
Study Overview
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, 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.
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 resolution of symptoms (symptom questionnaire)
II. Change in the fever curve resulting in shorter time to afebrile for 48 hours
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
- Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
- Azithromycin 500 mg taken by mouth on Day 1, followed by
- Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.
Intervention: Hydroxychloroquine Sulfate + Azithromycin (Combination Product)
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
- Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
- Azithromycin 500 mg taken by mouth on Day 1, followed by
- Azithromycin 250 mg taken by mouth once (1) time a day for four (4) days.
Intervention: Hydroxychloroquine Sulfate (Drug)
Arm 2: Hydroxychloroquine Sulfate alone
• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
Intervention: Hydroxychloroquine Sulfate (Drug)
Outcomes
Primary Outcomes
Changes in Patients Viral Load
Time Frame: Baseline and day six
Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sabiha Hussain, MD,MPH
Associate Professor of Medicine
Rutgers, The State University of New Jersey