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

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ClinicalTrials.gov Identifier: NCT04351191
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborators:
Mayo Hospital Lahore
Services Hospital, Lahore
Pakistan Kidney and Liver Institute
Information provided by (Responsible Party):
Ammar Sarwar, Beth Israel Deaconess Medical Center

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
Sars-CoV2 Symptomatic Condition Covid-19 Drug: Hydroxychloroquine Sulfate Regular dose Drug: Hydroxychloroquine Sulfate Loading Dose Drug: Chloroquine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : April 15, 2020
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2020


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Progression of symptoms [ Time Frame: 7 days ]
    Time to progression to next stage of SARS-CoV-2 disease severity index

  2. Mortality [ Time Frame: 30 days ]
    Death



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351191


Contacts
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Contact: Ammar Sarwar 0423-530-2701 ext 268 asarwar@bidmc.harvard.edu

Locations
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Pakistan
Expo Covid Isolation Center / Mayo Hospital Field Hospital Recruiting
Lahore, Punjab, Pakistan
Contact: Ammar Sarwar, MD    0423-530-2701 ext 268    asarwar@bidmc.harvard.edu   
Mayo Hospital / King Edward Medical University Recruiting
Lahore, Punjab, Pakistan
Contact: Ammar Sarwar, MD    0423-530-2701 ext 268    asarwar@bidmc.harvard.edu   
Pakistan Kidney and Liver Institute Recruiting
Lahore, Punjab, Pakistan
Contact: Ammar Sarwar, MD    0423-530-2701 ext 268    asarwar@bidmc.harvard.edu   
Services Hospital Not yet recruiting
Lahore, Punjab, Pakistan
Contact: Ammar Sarwar, MD    0423-530-2701 ext 268    asarwar@bidmc.harvard.edu   
Sponsors and Collaborators
Government of Punjab, Specialized Healthcare and Medical Education Department
Mayo Hospital Lahore
Services Hospital, Lahore
Pakistan Kidney and Liver Institute
Investigators
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Principal Investigator: Ammar Sarwar, MD Beth Israel Deaconess Medical Center
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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: April 17, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Chloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides