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Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting

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: NCT04370782
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Avni Thakore MD, St. Francis Hospital, New York

Brief Summary:
This is a randomized, open-label trial to assess the safety and efficacy of hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a higher risk COVID-19 positive outpatient population.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Drug: Zinc Sulfate Drug: Doxycycline Phase 4

Detailed Description:
COVID-19 is an aggressive and contagious virus, found to have high mortality especially in persons with comorbidities (Age>60, hypertension [HTN], diabetes mellitus [DM], Cancer, and otherwise immunocompromised). Zinc is a supplement with possible antiviral properties, having been shown to have effect in the common cold, many of which are due to coronavirus. In addition, elderly patients and patients with co-morbidities have high incidence of zinc deficiency. We are repleting zinc in all patients and studying its direct effect in combination with hydroxychloroquine, and an antibiotic, either azithromycin or doxycycline to see if there is enhanced treatment efficacy in early COVID-19 infection and assess the safety of these two regimen.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study Evaluating the Safety and Efficacy of Hydroxychloroquine and Zinc in Combination With Either Azithromycin or Doxycycline for the Treatment of COVID-19 in the Outpatient Setting
Actual Study Start Date : April 28, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Experimental Arm 1

Hydroxychloroquine

Azithromycin

Zinc sulfate

Drug: Hydroxychloroquine
Hydroxychloroquine 400mg twice a day (BID) on day 1, followed by 200mg BID for days 2-5

Drug: Azithromycin
Azithromycin 500mg on day 1, followed by 250mg once daily for days 2-5

Drug: Zinc Sulfate
Zinc sulfate 220mg once daily for 5 days

Experimental: Experimental Arm 2

Hydroxychloroquine

Doxycycline

Zinc sulfate

Drug: Hydroxychloroquine
Hydroxychloroquine 400mg twice a day (BID) on day 1, followed by 200mg BID for days 2-5

Drug: Zinc Sulfate
Zinc sulfate 220mg once daily for 5 days

Drug: Doxycycline
Doxycycline 200 mg once daily for 5 days




Primary Outcome Measures :
  1. Time to Resolution of Symptoms relative to baseline (day 1 of trial) [ Time Frame: Day 5 ]
    Patients will be assessed on day 5 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)

  2. Time to Resolution of Symptoms relative to baseline (day 1 of trial) [ Time Frame: Day 14 ]
    Patients will be assessed on day 14 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)

  3. Time to Resolution of Symptoms relative to baseline (day 1 of trial) [ Time Frame: Day 21 ]
    Patients will be assessed on day 21 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)

  4. Number of participants hospitalized and/or requiring repeat ER visits [ Time Frame: 21 days ]
    Number of participants hospitalized and/or requiring repeat ER visits related to COVID-19 complications

  5. ICU Length of Stay [ Time Frame: Until Discharged up to 30 days ]
    If hospitalized, number of participants admitted to the ICU, and number of days in the ICU

  6. Ventilator [ Time Frame: Until extubated up to 30 days ]
    If placed on ventilator, number of days on a ventilator


Secondary Outcome Measures :
  1. Severity of symptoms [ Time Frame: Day 5, Day 14, and Day 21 ]
    Severity of symptoms evaluated at day 5, day 14, and day 21 scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)

  2. Number of participants with adverse events due to drug regimen [ Time Frame: 21 days ]
    Number of participants with adverse events due to drug regimen

  3. Number of participants with QTc prolongation >500ms [ Time Frame: Days 1 thru 5, Day 10, Day 21 ]
    Assess all patients to evaluate for QTc prolongation >500ms



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to read and understand informed consent.
  • High initial clinical suspicion by physician based on signs and symptoms (fever, cough, myalgias, fatigue, shortness of breath) followed by RT-PCR for confirmation of COVID-19 diagnosis
  • Any gender
  • Age 60 years and older
  • Age 30-59 years with one or more of the following:

    • abnormal lung exam
    • abnormal oxygen staturation <95%
    • abnormal chest x-ray or chest CT
    • persistent fever >100.4 degrees Fahrenheit upon arrival to Emergency department (ED)
    • one of the following co-morbidities: hypertension, diabetes mellitus, history of coronary artery disease, chronic kidney disease (CKD), asthma, chronic obstructive pulmonary disease, current or former smoker, or morbid obesity (Body Mass Index ≥35)

Exclusion Criteria:

  • Pregnant or breastfeeding female
  • Severe COVID-19 requiring admission for inpatient treatment
  • Need for any oxygen supplementation
  • Need for mechanical ventilatory support
  • History of oxygen supplementation dependency
  • History of cancer with ongoing chemotherapy or radiation therapy
  • Concurrent antimicrobial therapy
  • Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds
  • Already taking hydroxychloroquine or chloroquine within 1 month
  • Known G6-PD deficiency
  • History of retinopathy
  • History of current cardiac diseases (heart failure, ventricular arrhythmias, Left bundle branch block and/or Right bundle branch block, QTc prolongation >480ms), or family history of sudden cardiac death
  • Ongoing use of drugs that prolong the QTc interval (antipsychotics, antidepressants, class I and III antiarrhythmics, triptans)
  • Severe renal disease: glomerular filtration rate (GFR) <30ml/min
  • Severe hepatic impairment (elevated total bilirubin >2 mg/dL, decreased albumin <2.8 g/dL, signs of jaundice and ascites.)
  • Active alcohol abuse (>5 drinks per day or >20 drinks per week.)
  • Seizure disorder, currently on medications
  • Known hypersensitivity to any tetracyclines.

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): NCT04370782


Contacts
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Contact: Avni Thakore, MD 516-563-7938 avni.thakore@chsli.org
Contact: Elizabeth S Haag, RN 516-622-4512 elizabeth.haag@chsli.org

Locations
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United States, New York
St Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Elizabeth Haag, RN    516-622-4512    elizabeth.haag@chsli.org   
Sponsors and Collaborators
St. Francis Hospital, New York
Investigators
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Principal Investigator: Avni Thakore, MD Saint Francis Memorial Hospital
Publications:

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Responsible Party: Avni Thakore MD, Principal Investigator, St. Francis Hospital, New York
ClinicalTrials.gov Identifier: NCT04370782    
Other Study ID Numbers: 20-21
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Avni Thakore MD, St. Francis Hospital, New York:
coronavirus
hydroxychloroquine
zinc sulfate
Additional relevant MeSH terms:
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Azithromycin
Doxycycline
Hydroxychloroquine
Zinc Sulfate
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Astringents
Physiological Effects of Drugs
Dermatologic Agents