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

December 8, 2020 updated by: Avni Thakore MD, St. Francis Hospital, New York

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Roslyn, New York, United States, 11576
        • St Francis Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 5
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)
Day 14
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)
Day 21
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
21 days
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
Until Discharged up to 30 days
Ventilator
Time Frame: Until extubated up to 30 days
If placed on ventilator, number of days on a ventilator
Until extubated up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 5, Day 14, and Day 21
Number of participants with adverse events due to drug regimen
Time Frame: 21 days
Number of participants with adverse events due to drug regimen
21 days
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
Days 1 thru 5, Day 10, Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Francis Hospital, New York

Investigators

  • Principal Investigator: Avni Thakore, MD, Saint Francis Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

April 26, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

December 9, 2020

Last Update Submitted That Met QC Criteria

December 8, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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