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

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ClinicalTrials.gov Identifier: NCT04408456
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Deba Prasad Dhibar, Postgraduate Institute of Medical Education and Research

Brief Summary:
Novel corona virus (SARS-CoV-2) epidemic which stared from Wuhan in China is now a well established pandemic worldwide. After Italy, Spain, Germany, United Kingdom and USA, India is at the edge of becoming the next epicentre of this Pandemic. If adequate preventive and therapeutic measures are not taken, India has very high risk of affecting million of 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 are 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. Indian council of medical research (ICMR) has advised for HCQ prophylaxis for all asymptomatic health care workers involved in taking care of suspected or confirmed COVID-19 cases and all asymptomatic household contacts of labarotory confirmed COVID-19 cases. But there is still lack of significant scientific data to prove or disprove the efficacy of HCQ for the treatment and post exposure chemo-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. Among this Punjab have highest population of non residential Indian (NRI) and most of them have returned home. This put our institute to handle highest burden of suspected cases of SARS-CoV-2 in northern India. So we have planned this open level control clinical trial to evaluate the efficacy of post exposure prophylaxis (PEP) with HCQ for the prevention of COVID-19 in asymptomatic individuals who are at risk for SARS-CoV-2 infection. All asymptomatic individuals who have undertaken international travel in last 2 weeks and all asymptomatic individual with direct contact with laboratory confirmed cases will be advised for home quarantine for 2 weeks along with social distancing and personal hygiene. They will be given the option for taking HCQ prophylaxis. These quarantined asymptomatic individuals will be assigned into one post exposure prophylaxis (PEP) group and one control 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 directly included in the control group. All symptomatic individual, and all health care workers related to suspected or proven COVID-19 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 not receive 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 and or throat swab of the participants will be taken for processing reverse transcription polymerase chain reaction (RTPCR) for the detection SARS-Cov-2 RNA to confirm CoVID-19. Samples for RTPCR will be taken when any asymptomatic participants become symptomatic and by the 5-14 days of contact in asymptomatic participants through in-hospital visit at the institute's communicable disease ward isolation. The participant with RTPCR positive and with or without symptoms will be defined as definite COVID-19 case and the RTPCR negative symptomatic participant will be defined as probable COVID-19 case. Asymptomatic participants with negative RTPCR will be defined as non-COVID case. Incidence of COVID-19 or probable COVID-19 or non-COVID case in previously asymptomatic participants will be compared between the PEP and control groups.

Condition or disease Intervention/treatment Phase
CoVID-19 Drug: HCQ Other: Standard therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Open Level Control Clinical Trial
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Post Exposure Prophylaxis (PEP) Group
Standard therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene Plus 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)
Drug: HCQ
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)

Other: Standard therapy
Home quarantine for 2 weeks plus social distancing plus personal hygiene

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




Primary Outcome Measures :
  1. Incidence confirmed case of COVID-19 [ Time Frame: 3 weeks ]
    Participant with RTPCR positive for SARS-CoV-2 and with or without symptoms will be defined as definite COVID-19 case.

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


Secondary Outcome Measures :
  1. Incidence of adverse drug reaction (ADR) [ Time Frame: 4 weeks ]
    Any adverse reaction related to Hydroxychloroquine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Asymptomatic individuals who have undertaken International travel in last 2 weeks
  2. Asymptomatic individual with direct contact with laboratory confirmed cases

Exclusion:

  1. Symptomatic individual
  2. Health care worker

Individual who will not give consent for HCQ prophylaxis and patients 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 directly included in the control groups.


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): NCT04408456


Locations
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India
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India, 160012
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Deba P Dhibar, MD PGIMER, Chandigarh, India
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Responsible Party: Deba Prasad Dhibar, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT04408456    
Other Study ID Numbers: IEC-04/2020-1624
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared with the concerned authority and Institutional Ethics committee as and when required.

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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:
CoVID-19
SARS-CoV-2
Hydroxychloroquine (HCQ)
post exposure prophylaxis (PEP)