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Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 (CHEER)

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ClinicalTrials.gov Identifier: NCT04359537
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Fibhaa Syed, Shaheed Zulfiqar Ali Bhutto Medical University

Study Description
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Brief Summary:
Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID 19.Healthcare personnel are amongst those at highest risk to contract the disease. Several health authorities are now recommending the use of hydroxychloroquine as pre-exposure prophylaxis is in health care personnel. Several studies are on going in this context. However there is a controversy regarding the dosage regimen. This drug has a half life of 22.4 days. In this study we will be comparing three different doses of Hydroxychloroquine and additionally have a control group in order to determine the efficacy of hydroxychloroquine as pre- exposure prophylaxis in healthcare personnel in various doses.

Condition or disease Intervention/treatment Phase
COVID 19 Drug: Hydroxychloroquine Sulfate 200 MG Other: Placebo Phase 2

Detailed Description:

Study design:

Phase 2 proof of concept study Study Type: Interventional (Clinical Trial) Estimated Enrollment : at least 200 participants Since the investigators have no current data on pre-exposure prophylaxis to calculate sample size statistically, so a minimum of 50 participants in each arm will be recruited including 20% attrition rate. The investigators will be recruiting a minimum of 200 participants in the study , that is at least 50 in each of the four arms.

Allocation: Randomized Intervention Model: Parallel Assignment Study model: Parallel group interventional study Location: SZABMU/PIMS Study duration: a minimum of 12 weeks from recruitment

Materials and Methods:

Participants will be recruited after approval from Ethical Review Board .A written informed consent will be taken from all participants. Participants fulfilling the eligibility criteria will be randomized to 4 arms.

Arm Intervention /treatment

Experimental group 1: Hydroxychloroquine 400 mg twice a day 1,followed by 400 mg weekly for a total of 12 weeks Drug: Hydroxychloroquin HCQ 200 mg, oral

Experimental group 2:Hydroxychloroquine 400 mg on day 1 followed by 400mg once every 3 weeks for a total of 12 weeks Drug: Hydroxychloroquin HCQ 200 mg, oral

Experimental group 3:Hydroxychloroquine 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks Drug: Hydroxychloroquin HCQ 200 mg, oral

Control Group : Placebo 200mg will be given on day 1 followed by Placebo 200mg every three weeks for a total of 12 weeks.

Base line characteristics of all participants will be recorded including age ,gender,role of healthcare personnel, comorbidities, and drugs the participant is using.

Samples will be collected for complete picture blood, liver and renal function tests and electrocardiogram. These tests will also be conducted every month till the end of the trial and the participants will be monitored for any adverse effects.

During the study duration all participants will self- report any symptoms related to COVID 19 and any adverse reactions from the drug. Participants having COVID 19 symptoms at any time will be tested by the gold standard test PCR for SARS-COV-2 using nasopharyngeal and oropharyngeal swabs.

All participants at the end of the study will have PCR for SARS-COV-2 and if available IgM and IgG serology to find out if they had any infection, did not get infected at all or only had asymptomatic or mild infection.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants fulfilling the eligibility criteria will be randomized to 4 arms by using Random Allocation Software version-2

Arm Intervention /treatment Experimental group 1: Hydroxychloroquine 400 mg twice a day 1,followed by 400 mg weekly for a total of 12 weeks

Experimental group 2:Hydroxychloroquine 400 mg on day 1 followed by 400 mg once every 3 weeks for a total of 12 weeks

Experimental group 3:Hydroxychloroquine 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks

Control Group :Placebo 200mg will be given on day 1 followed by Placebo 200mg every three weeks for a total of 12 weeks..
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Comparative Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 in Healthcare Personnel
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : August 25, 2020
Estimated Study Completion Date : September 25, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Hydroxychloroquine Sulphate will be administered at a dose of 400mg twice a day on day 1 followed by 400 mg once a week for a total of 12 weeks
 Drug: Hydroxychloroquine Sulfate 200 MG
Hydroxychloroquine Sulphate 200 mg tablets will be prescribed and instituted orally at the doses and regimens described
Other Name: Tab HCQ
Experimental: Arm 2
Hydroxychloroquine Sulphate will be admoinistered at a dose of 400 mg on day 1 followed by 400mg once every 3 weeks for at total of 12 weeks
 Drug: Hydroxychloroquine Sulfate 200 MG
Hydroxychloroquine Sulphate 200 mg tablets will be prescribed and instituted orally at the doses and regimens described
Other Name: Tab HCQ
Experimental: Arm 3
Hydroxychloroquine Sulphate will be administered at a dose of 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks
 Drug: Hydroxychloroquine Sulfate 200 MG
Hydroxychloroquine Sulphate 200 mg tablets will be prescribed and instituted orally at the doses and regimens described
Other Name: Tab HCQ
Placebo Comparator: Arm 4
Control group will recieve Placebo 200mg on day 1 followed by Placebo 200mg every three weeks for 12 weeks
 Other: Placebo
Control group will receive a Placebo tablet. Placebo 200mg will be given on Day 1 followed by Placebo 200mg every three weeks.


Outcome Measures
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Primary Outcome Measures :
  1. COVID-19-free survival in experimental arms compared to placebo [ Time Frame: 12 weeks ]
    Outcome reported as the percentage of participants in each arm who are COVID-19-free at the end of study treatment


Secondary Outcome Measures :
  1. Incidence of confirmed SARS-COV-2 detection [ Time Frame: 12 weeks ]
    Outcome reported as the percent of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment.

  2. Incidence of possible COVID-19 symptoms [ Time Frame: 12 weeks ]
    Outcome reported as the percent of participants in each arm who report COVID-19-related symptoms during study treatment

  3. Incidence of all-cause study medicine discontinuation [ Time Frame: 12 weeks ]
    Outcome reported as the percent of participants in each arm who discontinue study medication use for any reason during treatment.

  4. Ordinal Scale of COVID-19 Disease maximum severity if COVID-19 diagnosed at study end [ Time Frame: 12 weeks ]
    Participants will self-report COVID-19 status on an ordinal scale as follows: No illness (score=1), Illness with outpatient observation (score=2), Hospitalization (or post-hospital discharge) (score=3), Hospitalization with ICU stay (score 4),Death from COVID 19(score=5) Possible scores range from 1-5 with higher scores indicating greater disease severity.

  5. Incidence of Hospitalization for COVID-19 or death [ Time Frame: 12 weeks ]
    Outcome reported as the percent of participants in each arm who are hospitalized or expire due to COVID-19 during study treatment.

  6. Incidence of study medication-related adverse events [ Time Frame: 12 weeks ]
    Outcome reported as the percent of participants experiencing any possible adverse events from Hydroxychloroquine


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria after taking a written informed consent:

  • A healthcare worker at high risk for COVID19 exposure (defined below):

    • Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel) ;
    • Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists) ;
    • Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists, gastroenterologists performing endoscopy, Pulmonologists performing bronchoscopy);
    • First responders (i.e. EMTs, paramedics) ;
    • Persons working in the departments of General Medicine, Pulmonology, Infectious disease and Isolation wards.

Exclusion Criteria:

  • Active COVID-19 disease;
  • Confirmed prior COVID-19 disease;
  • Current fever, cough, shortness of breath;
  • Contraindication or hypersensitivity to chloroquine or hydroxychloroquine ad hypersensitivity to 4-aminoquinoline compounds;
  • Pregnancy;
  • Lactation;
  • Prior retinal eye disease;
  • Known Chronic Kidney disease, Stage 4 or 5 or dialysis;
  • Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency ;
  • Weight <40 kg;
  • Current use of chloroquine,hydroxychloroquine or cardiac medicines like flecainide, amiodarone, digoxin, procainamide, or propafenone;
  • Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen or methotrexate;
  • Current use of medications causing QT interval prolongation like: macrolides,antipsychotics,quinolones,antihistamines,SSRIs,tricyclic antidepressants, antifungals;
  • Recent Myocardial Infarction;
  • History of Epilepsy
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): NCT04359537


Contacts
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Contact: Fibhaa Syed, FRCP +923335300002 ext +923335300002 drfibhasyed@szabmu.edu.pk
Contact: Mohammed Ali Arif, FRCP +923335123701 ext +923335123701 mohammad_ali_arif@hotmail.com

Locations
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Pakistan
Shaheed Zulfiaqar Ali Bhutto Medical University Recruiting
Islamabad, Federal Capital, Pakistan, 44000
Contact: Fibhaa Syed, FRCP    +923335300002 ext +923335300002    fibhaasyed@gmail.com   
Contact: Mohammed Ali Ali Arif, FRCP    +923335123701    mohammad_ali_arif@hotmail.com   
Sponsors and Collaborators
Shaheed Zulfiqar Ali Bhutto Medical University
Investigators
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Principal Investigator: Fibhaa Syed, FRCP Shaheed Zylfiqar Ali Bhutto Medical University
Principal Investigator: Mohammed Ali Arif, FRCP Shaheed Zulfiqar Ali Bhutto Medical University
Study Director: Rauf Niazi, FRCP Shaheed Zulfiqar Ali Bhutto Medical University /PIMS
More Information
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Publications:

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Responsible Party: Fibhaa Syed, Assistan Professor Medicine, Shaheed Zulfiqar Ali Bhutto Medical University
ClinicalTrials.gov Identifier: NCT04359537    
Other Study ID Numbers: F.1-1/2015/ERB/SZABMU/549
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 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
Keywords provided by Fibhaa Syed, Shaheed Zulfiqar Ali Bhutto Medical University:
pre-exposure prophylaxis
Healthcare personnel
Additional relevant MeSH terms:
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Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
 Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents