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

Government of Punjab, Specialized Healthcare and Medical Education Department

Status and phase: Terminated; Phase 4

Conditions: Sars-CoV2; Covid-19; Symptomatic Condition

Treatments: Drug: Hydroxychloroquine Sulfate Loading Dose; Drug: Chloroquine; Drug: Hydroxychloroquine Sulfate Regular dose; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04351191

NBC-COVID1902

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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137 participants in 4 patient groups, including a placebo group

HCQ Regular dose

Active Comparator group

Description:

Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care

Treatment:

Drug: Hydroxychloroquine Sulfate Regular dose

HCQ Loading dose

Experimental group

Description:

Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care

Treatment:

Drug: Hydroxychloroquine Sulfate Loading Dose

CQ regular dose

Active Comparator group

Description:

Cholorquine 500 mg BID for 5 days plus standard of care

Treatment:

Drug: Chloroquine

Placebo

Placebo Comparator group

Description:

Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)

Treatment:

Drug: Placebo