- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04346667
Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds (PEACE)
March 8, 2021 updated by: Ammar Sarwar, Government of Punjab, Specialized Healthcare and Medical Education Department
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
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.
Study Overview
Status
Terminated
Study Type
Interventional
Enrollment (Actual)
125
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
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Pakistan Kidney and Liver Institute
-
Lahore, Punjab, Pakistan
- Expo Covid Center
-
Lahore, Punjab, Pakistan
- Mayo 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
20 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Arm 1
Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care
|
Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
|
EXPERIMENTAL: Arm 2
Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
|
Hydroxychloroquine administered as a loading dose only
|
ACTIVE_COMPARATOR: Arm 3
Chloroquine 500 mg BID for 5 days plus standard of care
|
Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
|
PLACEBO_COMPARATOR: Arm 4
Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
|
Standard of Care plus placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RT-PCR negative status
Time Frame: 6-7 days
|
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
|
6-7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression of symptoms
Time Frame: 7 days
|
Time to progression to next stage of SARS-CoV-2 disease severity index
|
7 days
|
Development of Symptoms
Time Frame: 7 days
|
Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
|
7 days
|
Adverse events
Time Frame: 7 days
|
Drug related adverse events as determined by data safety and monitoring board (DSMB)
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 14, 2020
Primary Completion (ACTUAL)
August 23, 2020
Study Completion (ACTUAL)
August 30, 2020
Study Registration Dates
First Submitted
April 13, 2020
First Submitted That Met QC Criteria
April 14, 2020
First Posted (ACTUAL)
April 15, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 10, 2021
Last Update Submitted That Met QC Criteria
March 8, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- COVID-19
- Coronavirus Infections
- Asymptomatic Diseases
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Amebicides
- Chloroquine
- Hydroxychloroquine
Other Study ID Numbers
- NBC-COVID19-02
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
No
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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