Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Primary Purpose
SARS-CoV-2, COVID-19
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine Sulfate + Azithromycin
Hydroxychloroquine Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2
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)
Sites / Locations
- Saint Barnabas Medical Center
- Robert Wood Johnson University Hopsital
- Rutgers Cancer Institute of New Jersey
- The University Hospital
- University Hospital-Newark
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
Arm 2: Hydroxychloroquine Sulfate alone
Arm 3: Placebo
Arm Description
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.
• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
Placebo pills Days 1-6. If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04336332
First Posted
March 31, 2020
Last Updated
February 6, 2023
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04336332
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Ineffectiveness of treatment
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
October 14, 2020 (Actual)
Study Completion Date
October 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Hydroxychloroquine Sulfate + Azithromycin
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2: Hydroxychloroquine Sulfate alone
Arm Type
Experimental
Arm Description
• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
Arm Title
Arm 3: Placebo
Arm Type
No Intervention
Arm Description
Placebo pills Days 1-6.
If you still have COVID-19 symptoms you will receive Hydroxychloroquine sulfate 200 mg by mouth three (3) times a day for 10 days
Intervention Type
Combination Product
Intervention Name(s)
Hydroxychloroquine Sulfate + Azithromycin
Other Intervention Name(s)
Hydroxychloroquine, Plaquenil, Z-Pak, Zithromax, Zmax
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate
Other Intervention Name(s)
Hydroxychloroquine, Plaquenil
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Changes in Patients Viral Load
Description
Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.
Time Frame
Baseline and day six
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabiha Hussain, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven K. Libutti, MD, FACS
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Robert Wood Johnson University Hopsital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
The University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
University Hospital-Newark
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
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