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

Covid-19 Clinical Trial

— PRECISE  

Official title:

Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Symptomatic 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: NCT04351191
• Other study ID #: NBC-COVID1902
• Status: Terminated
• Phase: Phase 4
• Start date: April 15, 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 137
• 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. 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

Related Conditions & MeSH terms

• Covid-19
• Sars-CoV2
• Symptomatic Condition

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 Isolation Center / Mayo Hospital Field Hospital	Lahore	Punjab
Pakistan	Mayo Hospital / King Edward Medical University	Lahore	Punjab
Pakistan	Pakistan Kidney and Liver Institute	Lahore	Punjab
Pakistan	Services Hospital	Lahore	Punjab

Sponsors (4)

Lead Sponsor	Collaborator
Government of Punjab, Specialized Healthcare and Medical Education Department	Mayo Hospital Lahore, Pakistan Kidney and Liver Institute, Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RT-PCR result	Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7	6th and 7th day
Secondary	Progression of symptoms	Time to progression to next stage of SARS-CoV-2 disease severity index	7 days
Secondary	Mortality	Death	30 days