PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds

Phase 4

Terminated

• Conditions: Sars-CoV2; Covid-19; Symptomatic Condition
• Interventions: Drug: Placebo; Drug: Hydroxychloroquine Sulfate Regular dose; Drug: Hydroxychloroquine Sulfate Loading Dose; Drug: Chloroquine

• Registration Number: NCT04351191
• Lead Sponsor: Government of Punjab, Specialized Healthcare and Medical Education Department

Brief Summary

To treat Pakistani patients with non-life threatening symptomatic SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different chloroquine and hydroxychloroquine dosing regimens in controlling SARS-CoV-2 infection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-14
• Study Start: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• 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: 137

Inclusion Criteria

1. Symptomatic patients: defined as fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
2. Nasopharyngeal RT-PCR positive SARS-CoV-2
3. Age 20-50 years
4. BMI 18-28 kg/m2
5. Informed consent

Exclusion Criteria

1. O2 saturation by pulse-oximeter below 93%
2. Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
3. Arrhythmias and/or history of arrythmia
4. Psoriasis and/or history of psoriasis
5. Neuropathy or myopathy and/or history of these
6. Hypoglycemia and/or history of hypoglycemia
7. Pre-existing hepatic disease
8. Pre-existing renal disease
9. Use of antacids within 1 week
10. Use of antiobiotics within 1 week
11. Pregnancy
12. RT-PCR performed >7 days prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
HCQ Regular dose	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
HCQ Loading dose	Hydroxychloroquine Sulfate Loading Dose	Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
CQ regular dose	Chloroquine	Cholorquine 500 mg BID for 5 days plus standard of care

Primary Outcome Measures

Name	Time	Method
RT-PCR result	6th and 7th day	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
Mortality	30 days	Death
Progression of symptoms	7 days	Time to progression to next stage of SARS-CoV-2 disease severity index

Trial Locations

Locations (4)

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

Mayo Hospital / King Edward Medical University; 🇵🇰 Lahore, Punjab, Pakistan

Expo Covid Isolation Center / Mayo Hospital Field Hospital; 🇵🇰 Lahore, Punjab, Pakistan

Services Hospital; 🇵🇰 Lahore, Punjab, Pakistan