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Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With choloroquinE Compounds (PEACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346667
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborators:
Mayo Hospital Lahore
Services Institute of Medical Sciences, Pakistan
Pakistan Kidney and Liver Institute
Forman Christian College
Harvard School of Public Health
Information provided by (Responsible Party):
Ammar Sarwar, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Coronavirus Infection Asymptomatic Condition COVID-19 Drug: Hydroxychloroquine Sulfate Regular dose Drug: Hydroxychloroquine Sulfate Loading Dose Drug: Chloroquine Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (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 14, 2020
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm 1
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: Arm 2
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: Arm 3
Chloroquine 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: Arm 4
Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
 Drug: Placebo
Standard of Care plus placebo


Outcome Measures
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Primary Outcome Measures :
  1. RT-PCR negative status [ Time Frame: 6-7 days ]
    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. Development of Symptoms [ Time Frame: 7 days ]
    Time to onset of fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).

  3. Adverse events [ Time Frame: 7 days ]
    Drug related adverse events as determined by data safety and monitoring board (DSMB)


Eligibility Criteria
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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. Nasopharyngeal RT-PCR positive SARS-CoV-2 patient
  2. Age 20-50 years
  3. BMI 18-28 kg/m2
  4. Informed consent

Exclusion Criteria:

  1. Symptoms: Cough, fever, shortness of breath
  2. O2 saturation by pulse-oximeter below 94%
  3. Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
  4. Arrhythmias and/or history of arrythmia
  5. Psoriasis and/or history of psoriasis
  6. Neuropathy or myopathy and/or history of these
  7. Hypoglycemia and/or history of hypoglycemia
  8. Pre-existing hepatic disease
  9. Pre-existing renal disease
  10. Use of antacids within 1 week
  11. Use of antibiotics within 1 week
  12. Pregnancy
  13. RT-PCR performed >3 days prior to enrollment
Contacts and Locations
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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): NCT04346667


Contacts
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Contact: Ammar Sarwar, MD +92-42-35302701-14 ext 268 asarwar@bidmc.harvard.edu

Locations
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Pakistan
Expo Covid Center Recruiting
Lahore, Punjab, Pakistan
Contact: Ammar Sarwar, MD    0423-5302701 ext 268    asarwar@bidmc.harvard.edu   
Mayo Hospital Recruiting
Lahore, Punjab, Pakistan
Contact: Ammar Sarwar, MD    0423-5302701 ext 268    asarwar@bidmc.harvard.edu   
Pakistan Kidney and Liver Institute Recruiting
Lahore, Punjab, Pakistan
Contact: Ammar Sarwar, MD    0423-5302701 ext 268    asarwar@bidmc.harvard.edu   
Sponsors and Collaborators
Government of Punjab, Specialized Healthcare and Medical Education Department
Mayo Hospital Lahore
Services Institute of Medical Sciences, Pakistan
Pakistan Kidney and Liver Institute
Forman Christian College
Harvard School of Public Health
More Information
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Responsible Party: Ammar Sarwar, Assistant Professor of Radiology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04346667    
Other Study ID Numbers: NBC-COVID19-02
First Posted: April 15, 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Asymptomatic Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
 Hydroxychloroquine
Chloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides