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
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 137
- Locations
- 4
- Primary Endpoint
- RT-PCR result
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic patients: defined as fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
- •Nasopharyngeal RT-PCR positive SARS-CoV-2
- •Age 20-50 years
- •BMI 18-28 kg/m2
- •Informed consent
Exclusion Criteria
- •O2 saturation by pulse-oximeter below 93%
- •Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
- •Arrhythmias and/or history of arrythmia
- •Psoriasis and/or history of psoriasis
- •Neuropathy or myopathy and/or history of these
- •Hypoglycemia and/or history of hypoglycemia
- •Pre-existing hepatic disease
- •Pre-existing renal disease
- •Use of antacids within 1 week
- •Use of antiobiotics within 1 week
- •RT-PCR performed >7 days prior to enrollment
Arms & Interventions
HCQ Regular dose
Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care
Intervention: Hydroxychloroquine Sulfate Regular dose (Drug)
HCQ Loading dose
Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
Intervention: Hydroxychloroquine Sulfate Loading Dose (Drug)
CQ regular dose
Cholorquine 500 mg BID for 5 days plus standard of care
Intervention: Chloroquine (Drug)
Placebo
Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
RT-PCR result
Time Frame: 6th and 7th day
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
Secondary Outcomes
- Mortality(30 days)
- Progression of symptoms(7 days)
Investigators
Ammar Sarwar
Assistant Professor, Harvard Medical School
Beth Israel Deaconess Medical Center