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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336332
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sabiha Hussain, MD,MPH, Rutgers, The State University of New Jersey

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021


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



Primary Outcome Measures :
  1. Changes in patients viral load [ Time Frame: Baseline, day 3 and day 6 ]
    Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.

  2. Second evaluation of changes in patients viral load [ Time Frame: Day 6 ]
    A second concurrent comparison will evaluate change in viral load at day 6 between hydroxychloroquine sulfate alone and supportive care.


Secondary Outcome Measures :
  1. Symptom questionnaire [ Time Frame: up to 6 months ]
    Time to resolution of symptoms

  2. Fever assessment [ Time Frame: up to 10 days ]
    Change in the fever curve resulting in shorter time to afebrile for 48 hours

  3. Vital Signs - Body Temperature [ Time Frame: up to 10 days ]
    Body temperature will be measured in degrees Fahrenheit using an automated thermometer which will be provided to the patient 4 times per day.

  4. Discharge [ Time Frame: up to 6 months ]
    Time to discharge (If hospitalized)

  5. Recovery [ Time Frame: up to 6 months ]
    Time to recovery (back to school, work, etc)

  6. Assessment of agent toxicity [ Time Frame: up to 10 days ]
    As measured by standard metrics

  7. Oropharynx swab sample collections [ Time Frame: up to 10 days ]
    Collection of Oropharynx swabs for viral load and microbiome analysis

  8. Blood Sample collections [ Time Frame: up to 10 days ]
    Collection of blood for viral load and microbiome analysis

  9. Viral shedding assessment - nasopharyngeal secretions [ Time Frame: up to 10 days ]
    Decrease in virus shedding in nasopharyngeal secretions such as Ferritin, D-dimer, CRP, Troponin and LDH

  10. Viral shedding assessment - serology [ Time Frame: up to 10 days ]
    Decrease in virus shedding in serology such as Ferritin, D-dimer, CRP, Troponin and LDH

  11. Cytokines in blood [ Time Frame: up to 10 days ]
    Measurement of cytokines in blood



Information from the National Library of Medicine

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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)

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


Contacts
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Contact: Sabiha Hussain, MD 732-235-7840 hussaisa@rwjms.rutgers.edu

Locations
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United States, New Jersey
Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Sara Ingersoll    973-322-5000    Sara.Ingersoll@rwjbh.org   
Principal Investigator: Anthony Carlino, MD         
Monmouth Medical Center Recruiting
Long Branch, New Jersey, United States, 07740
Contact: Kenneth Granet, MD    732-923-6702    kenneth.granet@rwjbh.org   
Principal Investigator: Kenneth Granet, MD         
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Margaret Guthrie    973-971-6347    Margaret.Guthrie@atlantichealth.org   
Principal Investigator: Eric Whitman, MD         
Robert Wood Johnson University Hopsital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Sabiha Hussain, MD    732-235-7840    hussaisa@rwjms.rutgers.edu   
Principal Investigator: Sabiha Hussain, MD         
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Sabiha Hussain, MD    732-235-7840    hussaisa@rwjms.rutgers.edu   
Principal Investigator: Sabiha Hussain, MD         
The University Hospital Recruiting
Newark, New Jersey, United States, 07103
Contact: Shobha Swaminathan, MD    973-972-1057    shobha.swaminathan@rutgers.edu   
Principal Investigator: Shobha Swaminathan, MD         
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07901
Contact: Eric Whitman, MD    973-971-7111    eric.whitman@atlantichealth.org   
Principal Investigator: Eric Whitman, MD         
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
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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 )
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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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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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents