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.
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
III. Normalization of vital signs
IV. Time to discharge (if hospitalized)
V. Assessment of agent toxicity as measured by standard metrics
VI. Collection of throat swab and blood for viral load, presence of IgM or IgG antibodies
VII. If feasible on samples collected for quantitative PCR decrease in virus shedding (in
oropharyngeal secretions)
VIII. Measures of cytokines in blood including IL6, IL-8, TNF, INF
IX. Routine standard of care labs obtained as part of the care of these patients such as
differential white count, CRP, troponin and LFTs will be analyzed for correlative trends
Combination Product: Hydroxychloroquine Sulfate + Azithromycin
Given PO
Other Name: Array
Drug: Hydroxychloroquine Sulfate
Given PO
Other Name: Array
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)
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Robert Wood Johnson University Hopsital
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
The University Hospital
Newark, New Jersey, United States
University Hospital-Newark
Newark, New Jersey, United States