Back to resultsPost-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds (PEACE)
Primary Purpose
SARS-CoV-2, Coronavirus Infection, Asymptomatic Condition
Status
Terminated
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Hydroxychloroquine Sulfate Regular dose
Hydroxychloroquine Sulfate Loading Dose
Chloroquine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2
Eligibility Criteria
Inclusion Criteria:
- Nasopharyngeal RT-PCR positive SARS-CoV-2 patient
- Age 20-50 years
- BMI 18-28 kg/m2
- Informed consent
Exclusion Criteria:
- Symptoms: Cough, fever, shortness of breath
- O2 saturation by pulse-oximeter below 94%
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
- Arrhythmias and/or history of arrythmia
- Psoriasis and/or history of psoriasis
- Neuropathy or myopathy and/or history of these
- Hypoglycemia and/or history of hypoglycemia
- Pre-existing hepatic disease
- Pre-existing renal disease
- Use of antacids within 1 week
- Use of antibiotics within 1 week
- Pregnancy
- RT-PCR performed >3 days prior to enrollment
Sites / Locations
- Expo Covid Center
- Mayo Hospital
- Pakistan Kidney and Liver Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care
Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
Chloroquine 500 mg BID for 5 days plus standard of care
Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
Outcomes
Primary Outcome Measures
RT-PCR negative status
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
Secondary Outcome Measures
Progression of symptoms
Time to progression to next stage of SARS-CoV-2 disease severity index
Development of Symptoms
Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
Adverse events
Drug related adverse events as determined by data safety and monitoring board (DSMB)
Full Information
NCT ID
NCT04346667
First Posted
April 13, 2020
Last Updated
March 8, 2021
Sponsor
Government of Punjab, Specialized Healthcare and Medical Education Department
Collaborators
Mayo Hospital Lahore, Services Institute of Medical Sciences, Pakistan, Pakistan Kidney and Liver Institute, Forman Christian College, Pakistan, Harvard School of Public Health (HSPH)
1. Study Identification
Unique Protocol Identification Number
NCT04346667
Brief Title
Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds
Acronym
PEACE
Official Title
Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (RT-PCR) Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual.
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
August 23, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government of Punjab, Specialized Healthcare and Medical Education Department
Collaborators
Mayo Hospital Lahore, Services Institute of Medical Sciences, Pakistan, Pakistan Kidney and Liver Institute, Forman Christian College, Pakistan, Harvard School of Public Health (HSPH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2, Coronavirus Infection, Asymptomatic Condition, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
Chloroquine 500 mg BID for 5 days plus standard of care
Arm Title
Arm 4
Arm Type
Placebo Comparator
Arm Description
Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate Regular dose
Intervention Description
Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate Loading Dose
Intervention Description
Hydroxychloroquine administered as a loading dose only
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Intervention Description
Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Standard of Care plus placebo
Primary Outcome Measure Information:
Title
RT-PCR negative status
Description
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
Time Frame
6-7 days
Secondary Outcome Measure Information:
Title
Progression of symptoms
Description
Time to progression to next stage of SARS-CoV-2 disease severity index
Time Frame
7 days
Title
Development of Symptoms
Description
Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
Time Frame
7 days
Title
Adverse events
Description
Drug related adverse events as determined by data safety and monitoring board (DSMB)
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nasopharyngeal RT-PCR positive SARS-CoV-2 patient
Age 20-50 years
BMI 18-28 kg/m2
Informed consent
Exclusion Criteria:
Symptoms: Cough, fever, shortness of breath
O2 saturation by pulse-oximeter below 94%
Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
Arrhythmias and/or history of arrythmia
Psoriasis and/or history of psoriasis
Neuropathy or myopathy and/or history of these
Hypoglycemia and/or history of hypoglycemia
Pre-existing hepatic disease
Pre-existing renal disease
Use of antacids within 1 week
Use of antibiotics within 1 week
Pregnancy
RT-PCR performed >3 days prior to enrollment
Facility Information:
Facility Name
Expo Covid Center
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Mayo Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Pakistan Kidney and Liver Institute
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds
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