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

COVID-19 Clinical Trial

— PEACE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04346667
• Other study ID #: NBC-COVID19-02
• Status: Terminated
• Phase: Phase 4
• Start date: April 14, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: March 2021
• Source: Government of Punjab, Specialized Healthcare and Medical Education Department
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: August 30, 2020
• Est. primary completion date: August 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Condition
• Asymptomatic Diseases
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• SARS-CoV-2
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Pakistan	Expo Covid Center	Lahore	Punjab
Pakistan	Mayo Hospital	Lahore	Punjab
Pakistan	Pakistan Kidney and Liver Institute	Lahore	Punjab

Sponsors (6)

Lead Sponsor	Collaborator
Government of Punjab, Specialized Healthcare and Medical Education Department	Forman Christian College, Pakistan, Harvard School of Public Health, Mayo Hospital Lahore, Pakistan Kidney and Liver Institute, Services Institute of Medical Sciences, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RT-PCR negative status	Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7	6-7 days
Secondary	Progression of symptoms	Time to progression to next stage of SARS-CoV-2 disease severity index	7 days
Secondary	Development of Symptoms	Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).	7 days
Secondary	Adverse events	Drug related adverse events as determined by data safety and monitoring board (DSMB)	7 days