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

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

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:

  1. Nasopharyngeal RT-PCR positive SARS-CoV-2 patient
  2. Age 20-50 years
  3. BMI 18-28 kg/m2
  4. Informed consent

Exclusion Criteria:

  1. Symptoms: Cough, fever, shortness of breath
  2. O2 saturation by pulse-oximeter below 94%
  3. Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
  4. Arrhythmias and/or history of arrythmia
  5. Psoriasis and/or history of psoriasis
  6. Neuropathy or myopathy and/or history of these
  7. Hypoglycemia and/or history of hypoglycemia
  8. Pre-existing hepatic disease
  9. Pre-existing renal disease
  10. Use of antacids within 1 week
  11. Use of antibiotics within 1 week
  12. Pregnancy
  13. 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

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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