NCT04408456: PEP-CQ

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

Completed Phase 3 Last updated 4 August 2020

What this trial tests

Phase 3 trial testing HCQ in CoVID-19 in 325 participants. Completed in 31 July 2020.

Timeline

1 March 2020

Primary endpoint
31 July 2020

31 July 2020

Quick facts

Lead sponsor	Post Graduate Institute of Medical Education and Research, Chandigarh
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	325
Start date	1 March 2020
Primary completion	31 July 2020
Estimated completion	31 July 2020
Sites	2 locations across India

Drugs / interventions tested

• HCQ (hcq) — full drug profile →
• Standard therapy — full drug profile →

Conditions studied

• CoVID-19 — all drugs for CoVID-19 →

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Who can join

18 and older, any sex, with CoVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Systematic Review of Treatment and Outcomes of Pregnant Women With COVID-19-A Call for Clinical Trials.
   Pastick KA, Nicol MR, Smyth E, Zash R, et al · · 2020 · cited 21× · PMID 32929403 · DOI 10.1093/ofid/ofaa350
2. Approaching coronavirus disease 2019: Mechanisms of action of repurposed drugs with potential activity against SARS-CoV-2.
   Lisi L, Lacal PM, Barbaccia ML, Graziani G. · · 2020 · cited 20× · PMID 32710969 · DOI 10.1016/j.bcp.2020.114169
3. COVID-19, the firestone in 21st century: a review on coronavirus disease and its clinical perspectives.
   Karthika C, Swathy Krishna R, Rahman MH, Akter R, et al · · 2021 · cited 11× · PMID 34599450 · DOI 10.1007/s11356-021-16654-9
4. Post-exposure prophylaxis with hydroxychloroquine for the prevention of COVID-19, a myth or a reality? The PEP-CQ Study.
   Dhibar DP, Arora N, Kakkar A, Singla N, et al · · 2020 · cited 11× · PMID 33166694 · DOI 10.1016/j.ijantimicag.2020.106224
5. Pandemic COVID-19: Current status and challenges of antiviral therapies.
   Chan W, He B, Wang X, He ML. · · 2020 · cited 8× · PMID 32837984 · DOI 10.1016/j.gendis.2020.07.001
6. Effective post-exposure prophylaxis of Covid-19 associated with hydroxychloroquine: Prospective dataset re-analysis incorporating novel, missing data
   Wiseman DM, Kory P, Saidi SA, Mazzucco D. · · 2020 · DOI 10.1101/2020.11.29.20235218