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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Azithromycin
Zinc Sulfate
Doxycycline
Sponsored by
St. Francis Hospital, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring coronavirus, hydroxychloroquine, zinc sulfate

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St Francis Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental Arm 1

Experimental Arm 2

Arm Description

Hydroxychloroquine Azithromycin Zinc sulfate

Hydroxychloroquine Doxycycline Zinc sulfate

Outcomes

Primary Outcome Measures

Time to Resolution of Symptoms relative to baseline (day 1 of trial)
Patients will be assessed on day 5 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Time to Resolution of Symptoms relative to baseline (day 1 of trial)
Patients will be assessed on day 14 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Time to Resolution of Symptoms relative to baseline (day 1 of trial)
Patients will be assessed on day 21 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Number of participants hospitalized and/or requiring repeat ER visits
Number of participants hospitalized and/or requiring repeat ER visits related to COVID-19 complications
ICU Length of Stay
If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
Ventilator
If placed on ventilator, number of days on a ventilator

Secondary Outcome Measures

Severity of symptoms
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)
Number of participants with adverse events due to drug regimen
Number of participants with adverse events due to drug regimen
Number of participants with QTc prolongation >500ms
Assess all patients to evaluate for QTc prolongation >500ms

Full Information

First Posted
April 26, 2020
Last Updated
December 8, 2020
Sponsor
St. Francis Hospital, New York
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1. Study Identification

Unique Protocol Identification Number
NCT04370782
Brief Title
Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Francis Hospital, New York

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
coronavirus, hydroxychloroquine, zinc sulfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm 1
Arm Type
Experimental
Arm Description
Hydroxychloroquine Azithromycin Zinc sulfate
Arm Title
Experimental Arm 2
Arm Type
Experimental
Arm Description
Hydroxychloroquine Doxycycline Zinc sulfate
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine 400mg twice a day (BID) on day 1, followed by 200mg BID for days 2-5
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin 500mg on day 1, followed by 250mg once daily for days 2-5
Intervention Type
Drug
Intervention Name(s)
Zinc Sulfate
Intervention Description
Zinc sulfate 220mg once daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
Doxycycline 200 mg once daily for 5 days
Primary Outcome Measure Information:
Title
Time to Resolution of Symptoms relative to baseline (day 1 of trial)
Description
Patients will be assessed on day 5 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Time Frame
Day 5
Title
Time to Resolution of Symptoms relative to baseline (day 1 of trial)
Description
Patients will be assessed on day 14 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Time Frame
Day 14
Title
Time to Resolution of Symptoms relative to baseline (day 1 of trial)
Description
Patients will be assessed on day 21 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Time Frame
Day 21
Title
Number of participants hospitalized and/or requiring repeat ER visits
Description
Number of participants hospitalized and/or requiring repeat ER visits related to COVID-19 complications
Time Frame
21 days
Title
ICU Length of Stay
Description
If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
Time Frame
Until Discharged up to 30 days
Title
Ventilator
Description
If placed on ventilator, number of days on a ventilator
Time Frame
Until extubated up to 30 days
Secondary Outcome Measure Information:
Title
Severity of symptoms
Description
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)
Time Frame
Day 5, Day 14, and Day 21
Title
Number of participants with adverse events due to drug regimen
Description
Number of participants with adverse events due to drug regimen
Time Frame
21 days
Title
Number of participants with QTc prolongation >500ms
Description
Assess all patients to evaluate for QTc prolongation >500ms
Time Frame
Days 1 thru 5, Day 10, Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avni Thakore, MD
Organizational Affiliation
Saint Francis Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting

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