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

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

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 Overview

• Status: Terminated
• Conditions: Covid-19; Sars-CoV2; Symptomatic Condition
• Intervention / Treatment: Drug: Hydroxychloroquine Sulfate Regular dose; Drug: Hydroxychloroquine Sulfate Loading Dose; Drug: Chloroquine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Expo Covid Isolation Center / Mayo Hospital Field Hospital
    • Lahore, Punjab, Pakistan
      • Mayo Hospital / King Edward Medical University
    • Lahore, Punjab, Pakistan
      • Pakistan Kidney and Liver Institute
    • Lahore, Punjab, Pakistan
      • Services Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RT-PCR result	Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7	6th and 7th day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of symptoms	Time to progression to next stage of SARS-CoV-2 disease severity index	7 days
Mortality	Death	30 days

Collaborators and Investigators

• Sponsor: Government of Punjab, Specialized Healthcare and Medical Education Department
• Collaborators: Services Hospital, Lahore; Mayo Hospital Lahore; Pakistan Kidney and Liver Institute
• Investigators: Principal Investigator: Ammar Sarwar, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): August 23, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Amebicides; Chloroquine; Hydroxychloroquine
• Other Study ID Numbers: NBC-COVID1902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No