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

Sponsor

Government of Punjab, Specialized Healthcare and Medical Education Department (Other)

Overall Status

Terminated

CT.gov ID

NCT04346667

Collaborator

Mayo Hospital Lahore (Other), Services Institute of Medical Sciences, Pakistan (Other), Pakistan Kidney and Liver Institute (Other), Forman Christian College, Pakistan (Other), Harvard School of Public Health (HSPH) (Other)

125

Enrollment

Locations

Arms

4.5

Actual Duration (Months)

41.7

Patients Per Site

9.2

Patients Per Site Per Month

Study Details

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

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 :

Apr 14, 2020

Actual Primary Completion Date :

Aug 23, 2020

Actual Study Completion Date :

Aug 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

RT-PCR negative status [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

Progression of symptoms [7 days]
Time to progression to next stage of SARS-CoV-2 disease severity index
Development of Symptoms [7 days]
Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
Adverse events [7 days]
Drug related adverse events as determined by data safety and monitoring board (DSMB)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Expo Covid Center	Lahore	Punjab	Pakistan
2	Mayo Hospital	Lahore	Punjab	Pakistan
3	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)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 15, 2020

Last Update Posted:

Mar 10, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Coronavirus Infections

Asymptomatic Diseases

Hydroxychloroquine

Chloroquine

Study Results

No Results Posted as of Mar 10, 2021