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

Phase 4

Terminated

• Conditions: Coronavirus Infection; Asymptomatic Condition; SARS-CoV-2; COVID-19
• Interventions: Drug: Hydroxychloroquine Sulfate Regular dose; Drug: Hydroxychloroquine Sulfate Loading Dose; Drug: Placebo; Drug: Chloroquine

• Registration Number: NCT04346667
• Lead Sponsor: Government of Punjab, Specialized Healthcare and Medical Education Department

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-13
• Study Start: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-15
• Primary Completion: 2020-08-23
• Study Completion: 2020-08-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Hydroxychloroquine Sulfate Regular dose	Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care
Arm 2	Hydroxychloroquine Sulfate Loading Dose	Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
Arm 4	Placebo	Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
Arm 3	Chloroquine	Chloroquine 500 mg BID for 5 days plus standard of care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (3)

Mayo Hospital; 🇵🇰 Lahore, Punjab, Pakistan

Pakistan Kidney and Liver Institute; 🇵🇰 Lahore, Punjab, Pakistan

Expo Covid Center; 🇵🇰 Lahore, Punjab, Pakistan