Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds (PEACE)

• ClinicalTrials.gov Identifier: NCT04346667
• Recruitment Status: Terminated
• First Posted: April 15, 2020
• Last Update Posted: March 10, 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)
• Information provided by (Responsible Party): Ammar Sarwar, Beth Israel Deaconess Medical Center

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.

Condition or disease	Intervention/treatment	Phase
SARS-CoV-2; Coronavirus Infection; Asymptomatic Condition; COVID-19	Drug: Hydroxychloroquine Sulfate Regular dose; Drug: Hydroxychloroquine Sulfate Loading Dose; Drug: Chloroquine; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 14, 2020
• Actual Primary Completion Date: August 23, 2020
• Actual Study Completion Date: August 30, 2020

Arms and Interventions

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	Drug: Hydroxychloroquine Sulfate Regular dose; 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	Drug: Hydroxychloroquine Sulfate Loading Dose; Hydroxychloroquine administered as a loading dose only
Active Comparator: Arm 3; Chloroquine 500 mg BID for 5 days plus standard of care	Drug: Chloroquine; 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)	Drug: Placebo; Standard of Care plus placebo

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Progression of symptoms [ Time Frame: 7 days ]
   Time to progression to next stage of SARS-CoV-2 disease severity index
2. 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).
3. Adverse events [ Time Frame: 7 days ]
   Drug related adverse events as determined by data safety and monitoring board (DSMB)

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Pakistan

Expo Covid Center

Lahore, Punjab, Pakistan

Mayo Hospital

Lahore, Punjab, Pakistan

Pakistan Kidney and Liver Institute

Lahore, Punjab, Pakistan

Sponsors and Collaborators

Government of Punjab, Specialized Healthcare and Medical Education Department

Mayo Hospital Lahore

Services Institute of Medical Sciences, Pakistan

Pakistan Kidney and Liver Institute

Forman Christian College, Pakistan

Harvard School of Public Health (HSPH)

More Information

• Responsible Party: Ammar Sarwar, Assistant Professor of Radiology, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT04346667
• Other Study ID Numbers: NBC-COVID19-02
• First Posted: April 15, 2020
• Last Update Posted: March 10, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

COVID-19; Coronavirus Infections; Asymptomatic Diseases; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Hydroxychloroquine; Chloroquine; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Amebicides