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

Primary Purpose

Sars-CoV2, Symptomatic Condition, Covid-19

Status
Terminated
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Hydroxychloroquine Sulfate Regular dose
Hydroxychloroquine Sulfate Loading Dose
Chloroquine
Placebo
Sponsored by
Government of Punjab, Specialized Healthcare and Medical Education Department
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sars-CoV2

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Placebo Comparator

Arm Label

HCQ Regular dose

HCQ Loading dose

CQ regular dose

Placebo

Arm Description

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

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

Cholorquine 500 mg BID for 5 days plus standard of care

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

Outcomes

Primary Outcome Measures

RT-PCR result
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7

Secondary Outcome Measures

Progression of symptoms
Time to progression to next stage of SARS-CoV-2 disease severity index
Mortality
Death

Full Information

First Posted
April 14, 2020
Last Updated
March 8, 2021
Sponsor
Government of Punjab, Specialized Healthcare and Medical Education Department
Collaborators
Mayo Hospital Lahore, Services Hospital, Lahore, Pakistan Kidney and Liver Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04351191
Brief Title
PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds
Acronym
PRECISE
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
August 23, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government of Punjab, Specialized Healthcare and Medical Education Department
Collaborators
Mayo Hospital Lahore, Services Hospital, Lahore, Pakistan Kidney and Liver Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV2, Symptomatic Condition, Covid-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective double blind randomized superiority clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCQ Regular dose
Arm Type
Active Comparator
Arm Description
Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care
Arm Title
HCQ Loading dose
Arm Type
Experimental
Arm Description
Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
Arm Title
CQ regular dose
Arm Type
Active Comparator
Arm Description
Cholorquine 500 mg BID for 5 days plus standard of care
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate Regular dose
Intervention Description
Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine Sulfate Loading Dose
Intervention Description
Hydroxychloroquine administered as a loading dose only
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Intervention Description
Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Standard of Care plus placebo
Primary Outcome Measure Information:
Title
RT-PCR result
Description
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
Time Frame
6th and 7th day
Secondary Outcome Measure Information:
Title
Progression of symptoms
Description
Time to progression to next stage of SARS-CoV-2 disease severity index
Time Frame
7 days
Title
Mortality
Description
Death
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Pregnancy RT-PCR performed >7 days prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ammar Sarwar, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Expo Covid Isolation Center / Mayo Hospital Field Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Mayo Hospital / King Edward Medical University
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Pakistan Kidney and Liver Institute
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Name
Services Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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