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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04346667
Acronym
PEACE
Enrollment
125
Registered
2020-04-15
Start date
2020-04-14
Completion date
2020-08-30
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Condition, Coronavirus Infection, COVID-19, SARS-CoV-2

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.

Interventions

DRUGHydroxychloroquine Sulfate Regular dose

Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2

DRUGHydroxychloroquine Sulfate Loading Dose

Hydroxychloroquine administered as a loading dose only

DRUGChloroquine

Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2

DRUGPlacebo

Standard of Care plus placebo

Sponsors

Mayo Hospital Lahore
CollaboratorOTHER
Services Institute of Medical Sciences, Pakistan
CollaboratorOTHER_GOV
Pakistan Kidney and Liver Institute
CollaboratorUNKNOWN
Forman Christian College, Pakistan
CollaboratorOTHER
Harvard School of Public Health (HSPH)
CollaboratorOTHER
Government of Punjab, Specialized Healthcare and Medical Education Department
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
RT-PCR negative status6-7 daysPercentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7

Secondary

MeasureTime frameDescription
Progression of symptoms7 daysTime to progression to next stage of SARS-CoV-2 disease severity index
Development of Symptoms7 daysTime to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate \>22 per minute).
Adverse events7 daysDrug related adverse events as determined by data safety and monitoring board (DSMB)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026