Clinical trial NCT04336332: Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Official title: Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: SARS-CoV-2
COVID-19
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Changes in Patients Viral Load
timeFrame: Baseline and day six
Secondary outcomes:
Other outcomes:
Locations:
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hopsital
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Newark
country: United States
facility: The University Hospital
state: New Jersey
city: Newark
country: United States
facility: University Hospital-Newark
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Sabiha Hussain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers Cancer Institute of New Jersey
name: Steven K. Libutti, MD, FACS
role: STUDY_CHAIR
References: