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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336332
Recruitment Status : Terminated (Ineffectiveness of treatment)
First Posted : April 7, 2020
Results First Posted : February 28, 2023
Last Update Posted : February 28, 2023
Sponsor:
Information provided by (Responsible Party):
Sabiha Hussain, MD,MPH, Rutgers, The State University of New Jersey

Study Description
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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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 COVID-19 Combination Product: Hydroxychloroquine Sulfate + Azithromycin Drug: Hydroxychloroquine Sulfate Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : October 14, 2020
Actual Study Completion Date : October 14, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: Hydroxychloroquine Sulfate + Azithromycin
  • 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.
 Combination Product: Hydroxychloroquine Sulfate + Azithromycin
Given PO
Other Names:
  • Hydroxychloroquine
  • Plaquenil
  • Z-Pak
  • Zithromax
  • Zmax

Drug: Hydroxychloroquine Sulfate
Given PO
Other Names:
  • Hydroxychloroquine
  • Plaquenil
Experimental: Arm 2: Hydroxychloroquine Sulfate alone
• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days
 Drug: Hydroxychloroquine Sulfate
Given PO
Other Names:
  • Hydroxychloroquine
  • Plaquenil
No Intervention: Arm 3: Placebo
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Patients Viral Load [ Time Frame: Baseline and day six ]
    Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336332


Locations
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United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Robert Wood Johnson University Hopsital
New Brunswick, New Jersey, United States, 08901
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
The University Hospital
Newark, New Jersey, United States, 07103
University Hospital-Newark
Newark, New Jersey, United States, 07112
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Sabiha Hussain, MD Rutgers, The State University of New Jersey
Study Chair: Steven K. Libutti, MD, FACS Rutgers Cancer Institute of New Jersey
  Study Documents (Full-Text)

Documents provided by Sabiha Hussain, MD,MPH, Rutgers, The State University of New Jersey:
Study Protocol  [PDF] May 8, 2020
Statistical Analysis Plan  [PDF] May 8, 2020
Informed Consent Form: ICF #1  [PDF] April 21, 2020
Informed Consent Form: ICF #2  [PDF] April 21, 2020

More Information
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Responsible Party: Sabiha Hussain, MD,MPH, Associate Professor of Medicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04336332    
Other Study ID Numbers: 002011
Pro2020000712 ( Other Identifier: Rutgers Health Sciences IRB )
Pro2020000712 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
First Posted: April 7, 2020    Key Record Dates
Results First Posted: February 28, 2023
Last Update Posted: February 28, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents