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



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

Active, not recruiting
SARS-CoV-2
COVID-19

Combination Product: Hydroxychloroquine Sulfate + Azithromycin
Given PO
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
Other Name: Hydroxychloroquine
Other Name: Plaquenil
Other Name: Z-Pak
Other Name: Zithromax
Other Name: Zmax

Drug: Hydroxychloroquine Sulfate
Given PO
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
Arm 2: Hydroxychloroquine Sulfate alone
Other Name: Hydroxychloroquine
Other Name: Plaquenil

Eligibility 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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
United States
Locations

Saint Barnabas Medical Center
Livingston, New Jersey, 07039

Robert Wood Johnson University Hopsital
New Brunswick, New Jersey, 08901

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903

The University Hospital
Newark, New Jersey, 07103

Sabiha Hussain, MD
Principal Investigator
Rutgers, The State University of New Jersey

~

Steven K. Libutti, MD, FACS
Study Chair
Rutgers Cancer Institute of New Jersey

Rutgers, The State University of New Jersey
NCT Number
MeSH Terms
Azithromycin
Hydroxychloroquine