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
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.

Terminated
SARS-COV2
Symptomatic Condition
COVID-19

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: 50 Years
Countries
Pakistan
Locations

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, Pakistan

Ammar Sarwar, MD, Principal Investigator
Beth Israel Deaconess Medical Center

Government of Punjab, Specialized Healthcare and Medical Education Department
NCT Number
MeSH Terms
COVID-19
Hydroxychloroquine
Chloroquine