Efficacy of Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19 (PEP-CQ)
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04408456 |
Recruitment Status :
Completed
First Posted : May 29, 2020
Last Update Posted : August 4, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
CoVID-19 | Drug: HCQ Other: Standard therapy | Phase 3 |

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 |

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 |
- 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.
- 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.
- Incidence of adverse drug reaction (ADR) [ Time Frame: 4 weeks ]Any adverse reaction related to Hydroxychloroquine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion:
- Asymptomatic individuals who have undertaken International travel in last 2 weeks
- Asymptomatic individual with direct contact with laboratory confirmed cases
Exclusion:
- Symptomatic individual
- 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.

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
India | |
Post Graduate Institute of Medical Education and Research (PGIMER) | |
Chandigarh, India, 160012 | |
Post Graduate Institute of Medical Education and Research | |
Chandigarh, India, 160012 |
Principal Investigator: | Deba P Dhibar, MD | PGIMER, Chandigarh, India |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
CoVID-19 SARS-CoV-2 Hydroxychloroquine (HCQ) post exposure prophylaxis (PEP) |