NCT04346667

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Government of Punjab, Specialized Healthcare and Medical Education Department · Other Government
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine Sulfate Regular dose	Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
DRUG	Hydroxychloroquine Sulfate Loading Dose	Hydroxychloroquine administered as a loading dose only
DRUG	Chloroquine	Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
DRUG	Placebo	Standard of Care plus placebo

Timeline

• Start date: 2020-04-14
• Primary completion: 2020-08-23
• Completion: 2020-08-30
• First posted: 2020-04-15
• Last updated: 2021-03-10

Locations

3 sites across 1 country: Pakistan