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Clinical Trials/NCT04351191
NCT04351191TerminatedPhase 4

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

Government of Punjab, Specialized Healthcare and Medical Education Department4 sites in 1 country137 target enrollmentStarted: April 15, 2020Last updated:
Conditions
Interventions
Drugs

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

Active Comparator

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

Experimental

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

Intervention: Hydroxychloroquine Sulfate Loading Dose (Drug)

CQ regular dose

Active Comparator

Cholorquine 500 mg BID for 5 days plus standard of care

Intervention: Chloroquine (Drug)

Placebo

Placebo Comparator

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

Sponsor
Government of Punjab, Specialized Healthcare and Medical Education Department
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Ammar Sarwar

Assistant Professor, Harvard Medical School

Beth Israel Deaconess Medical Center

Study Sites (4)

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