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

Government of Punjab, Specialized Healthcare and Medical Education Department

Status and phase: Terminated; Phase 4

Conditions: COVID-19; Asymptomatic Condition; SARS-CoV-2; Coronavirus Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04346667

NBC-COVID19-02

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 4 patient groups, including a placebo group

Arm 1

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

Arm 2

Experimental group

Description:

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

Treatment:

Drug: Hydroxychloroquine Sulfate Loading Dose

Arm 3

Active Comparator group

Description:

Chloroquine 500 mg BID for 5 days plus standard of care

Treatment:

Drug: Chloroquine

Arm 4

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo