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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04336332
• Other study ID #: 002011
• Secondary ID: Pro2020000712Pro
• Status: Terminated
• Phase: Phase 2
• Start date: April 1, 2020
• Est. completion date: October 14, 2020

Study information

• Verified date: February 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Combination Product:
• Hydroxychloroquine Sulfate + Azithromycin
Given PO

Drug:
• Hydroxychloroquine Sulfate
Given PO

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Patients Viral Load	Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.	Baseline and day six