Study Stopped
Poor accrual.
Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds
PEACE
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
1 other identifier
interventional
125
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2020
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2020
CompletedStudy Start
First participant enrolled
April 14, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedMarch 10, 2021
March 1, 2021
4 months
April 13, 2020
March 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
RT-PCR negative status
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
6-7 days
Secondary Outcomes (3)
Progression of symptoms
7 days
Development of Symptoms
7 days
Adverse events
7 days
Study Arms (4)
Arm 1
ACTIVE COMPARATORHydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care
Arm 2
EXPERIMENTALHydroxychloroquine loading dose (400 mg BID) alone plus standard of care
Arm 3
ACTIVE COMPARATORChloroquine 500 mg BID for 5 days plus standard of care
Arm 4
PLACEBO COMPARATORStandard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
Interventions
Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
Hydroxychloroquine administered as a loading dose only
Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
Eligibility Criteria
You may qualify if:
- Nasopharyngeal RT-PCR positive SARS-CoV-2 patient
- Age 20-50 years
- BMI 18-28 kg/m2
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Government of Punjab, Specialized Healthcare and Medical Education Departmentlead
- Mayo Hospital Lahorecollaborator
- Services Institute of Medical Sciences, Pakistancollaborator
- Pakistan Kidney and Liver Institutecollaborator
- Forman Christian College, Pakistancollaborator
- Harvard School of Public Health (HSPH)collaborator
Study Sites (3)
Expo Covid Center
Lahore, Punjab Province, Pakistan
Mayo Hospital
Lahore, Punjab Province, Pakistan
Pakistan Kidney and Liver Institute
Lahore, Punjab Province, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Radiology
Study Record Dates
First Submitted
April 13, 2020
First Posted
April 15, 2020
Study Start
April 14, 2020
Primary Completion
August 23, 2020
Study Completion
August 30, 2020
Last Updated
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share