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Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19 (PEP-CQ)

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ClinicalTrials.gov Identifier: NCT04858633
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Deba Prasad Dhibar, Postgraduate Institute of Medical Education and Research

Brief Summary:

COVID-19 affected more than 9 million of people with more than 130 thousand death in India. If adequate preventive and therapeutic measures are not taken, India has very high risk of affecting million of more people with high mortality because of the large population along with very high population density. At present there are no definitive therapeutic drugs or vaccine available for the treatment and prevention of SARS-CoV-2 infection. Symptomatic and supportive care are being given to COVID-19 cases along with isolation and quarantine measure are being taken for the suspected individual at risk for COVID-19 to limit the spread of the SARS-CoV-2 infection . Among the all the drugs being used for the treatment of COVID-19, hydroxychloroquine (HCQ), has given some rays of hope to battle against this deadly pandemic. HCQ has some anti viral effect against SARS-CoV in vitro. HCQ is quite safe and being used in rheumatology patients for lifelong without much side effect, so it allow for higher dose without any significant side effects and drug-drug interaction. Recently published clinical trial suggested HCQ can be used for the therapeutic purpose of the SARS-CoV-2 infection and many governments have endorsed that due to lack of any other better alternative drugs. Indian council of medical research (ICMR) has advised for HCQ prophylaxis for the people who are at risk for developing SARS-CoV-2 infection, all asymptomatic health care workers involved in taking care of suspected or confirmed COVID-19 cases and all asymptomatic household contacts of laboratory confirmed COVID-19 cases. This encouraged us to conduct an open level clinical trial on HCQ as post exposure prophylaxis (PEP) for the prevention of COVID-19 in asymptomatic high risk house hold contact of the laboratory confirmed COVID-19 cases. The result was very promising showing absolute risk reduction of around 9% in participant who received PEP with HCQ as compared to the control group and there was no serious adverse event. But there is still conflicting scientific data to prove or disprove the efficacy of HCQ for the treatment and prophylaxis for SARS-CoV-2 infection. Being a tertiary care centre we are catering many states which include Punjab, hariyana, himachal Pradesh, Uttara khand, Uttar Pradesh. This put our institute to handle highest burden of suspected cases of SARS-CoV-2 in northern India. So we have subsequently planned this double blind clinical trial to evaluate the efficacy of HCQ as PEP for the prevention of COVID-19 in asymptomatic individuals who are at risk for SARS-CoV-2 infection.

The asymptomatic individual with direct contact with laboratory confirmed COVID-19 cases will be randomized into one PEP group and one control/placebo group as per inclusion and exclusion criteria. Individual who will not give consent for HCQ prophylaxis and those with contraindication for HCQ therapy like, hypersensitivity to HCQ or 4-aminoquinolone derivatives, patients with known retionopathy, cardiac arrhythmia, G6PD deficiency, psoriasis and pregnancy will be excluded from the study. All symptomatic individual and all health care workers related to suspected or proven COVID-19 and who received CoVID-19 vaccine will be excluded from the study. The PEP group will receive tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg). The control group will receive placebo instead of HCQ. Both the groups will receive standard care of therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene. They will be followed up for 4 weeks telephonically or physically as and when required and will be enquired regarding development of any COVID-19 symptoms like fever, cough, sore throat, shortness of breath, diarrhoea, myalgia. During follow up nasopharyngeal swab of the participants will be taken for processing reverse transcription polymerase chain reaction (RTPCR) for the detection of SARS-CoV-2 RNA to confirm the CoVID-19. Samples for RTPCR will be taken when any asymptomatic participants becomes symptomatic and by the 5-14 days of contact in asymptomatic participants through in-hospital visit at the institute's COVID-19 screening clinic.


Condition or disease Intervention/treatment Phase
Covid19 COVID-19 Prevention Drug: Hydroxychloroquine (HCQ) Other: Standard care Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19 in Asymptomatic Individual at Risk for SARS-CoV-2 Infection-A Randomized Control Clinical Trial
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PEP group
Tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total 5 tablets, cumulative dose of 2000 mg)
Drug: Hydroxychloroquine (HCQ)
Tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total 5 tablets, cumulative dose of 2000 mg )

Other: Standard care
Standard therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene

Placebo Comparator: Control group
Placebo one tablet 12 hourly on day one followed by one tablet once weekly for 3 weeks (total 5 tablets)
Other: Standard care
Standard therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene

Other: Placebo
Tablet placebo one tablet 12 hourly on day one followed by one tablet once weekly for 3 weeks (total 5 tablets)




Primary Outcome Measures :
  1. Incidence of COVID-19 [ Time Frame: 4 weeks ]
    Both the definite and probable COVID-19 cases together are defined as COVID-19 case

  2. Definite COVID-19 [ Time Frame: 4 weeks ]
    Participant with RTPCR positive for SARS-CoV-2 and with or without symptoms will be defined as definite COVID-19 case

  3. Probable COVID-19 [ Time Frame: 4 weeks ]
    The participant with new onset symptoms, but RTPCR negative for SARS-CoV-2 or cannot be performed for any reason will be defined as probable COVID-19 case.


Secondary Outcome Measures :
  1. New onset symptoms of COVID-19 [ Time Frame: 4 weeks ]
    Incidence of new onset symptoms of COVID-19 in asymptomatic participants

  2. Compliance [ Time Frame: 4 weeks ]
    Percentage of participants will be completing the advised therapy

  3. Adverse drug reaction (ADR) [ Time Frame: 4 weeks ]
    Incidence of adverse drug reaction among the participants



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Gender: Male/Female
  2. Age of ≥18 years
  3. Asymptomatic individual with direct contact with laboratory confirmed COVID-19 cases

Exclusion Criteria:

1. Symptomatic individual 2. Health care worker 3. Individual who will not give consent for HCQ prophylaxis 4. Contraindication for HCQ therapy 5. Pregnancy 6. Individual who received COVID-19 vaccine

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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): NCT04858633


Contacts
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Contact: Deba Prasad Dhibar, MD +911722756670 dhibar.dp@pgimer.edu.in

Locations
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India
Post Graduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Deba Prasad dhibar, MD    +911722756670    dhibar.dp@pgimer.edu.in   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
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Responsible Party: Deba Prasad Dhibar, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT04858633    
Other Study ID Numbers: INT/IEC/2021/SPL456
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data requests should be submitted to the PI (DPD) for consideration. Data sharing may be considered by the PI after due approval from IEC.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deba Prasad Dhibar, Postgraduate Institute of Medical Education and Research:
Covid19, Hydroxychloroquine (HCQ)
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