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

Sponsor
Government of Punjab, Specialized Healthcare and Medical Education Department (Other)
Overall Status
Terminated
CT.gov ID
NCT04351191
Collaborator
Mayo Hospital Lahore (Other), Services Hospital, Lahore (Other), Pakistan Kidney and Liver Institute (Other)
137
Enrollment
4
Locations
4
Arms
4.5
Actual Duration (Months)
34.3
Patients Per Site
7.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydroxychloroquine Sulfate Regular dose
  • Drug: Hydroxychloroquine Sulfate Loading Dose
  • Drug: Chloroquine
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
137 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective double blind randomized superiority clinical trial.Prospective double blind randomized superiority clinical trial.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 15, 2020
Actual Primary Completion Date :
Aug 23, 2020
Actual Study Completion Date :
Aug 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: HCQ Regular dose

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

Drug: Hydroxychloroquine Sulfate Regular dose
Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
Experimental: HCQ Loading dose

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

Drug: Hydroxychloroquine Sulfate Loading Dose
Hydroxychloroquine administered as a loading dose only
Active Comparator: CQ regular dose

Cholorquine 500 mg BID for 5 days plus standard of care

Drug: Chloroquine
Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
Placebo Comparator: Placebo

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

Drug: Placebo
Standard of Care plus placebo

Outcome Measures

Primary Outcome Measures

  1. RT-PCR result [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 Outcome Measures

  1. Progression of symptoms [7 days]

    Time to progression to next stage of SARS-CoV-2 disease severity index

  2. Mortality [30 days]

    Death

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Expo Covid Isolation Center / Mayo Hospital Field Hospital Lahore Punjab Pakistan
2 Mayo Hospital / King Edward Medical University Lahore Punjab Pakistan
3 Pakistan Kidney and Liver Institute Lahore Punjab Pakistan
4 Services Hospital Lahore Punjab Pakistan

Sponsors and Collaborators

  • Government of Punjab, Specialized Healthcare and Medical Education Department
  • Mayo Hospital Lahore
  • Services Hospital, Lahore
  • Pakistan Kidney and Liver Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ammar Sarwar, Assistant Professor, Harvard Medical School, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT04351191
Other Study ID Numbers:
  • NBC-COVID1902
First Posted:
Apr 17, 2020
Last Update Posted:
Mar 10, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Hydroxychloroquine
Chloroquine

Study Results

No Results Posted as of Mar 10, 2021