lancet-header
Preprints with The Lancet is part of SSRN´s First Look, a place where journals and other research experts identify content of interest prior to publication. These preprint papers are not peer-reviewed. Authors have either opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet, or submitted directly via SSRN. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These papers should not be used for clinical decision making or reporting of research to a lay audience without indicating that this is preliminary research that has not been peer-reviewed. For more information see the Comment published in The Lancet, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com

Hydroxychloroquine Pre-Exposure Prophylaxis for COVID-19 Among Healthcare Workers: Initial Experience from India

28 Pages Posted: 22 Jul 2020

See all articles by Harshith B. Kadnur

Harshith B. Kadnur

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Anivita Aggarwal

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Manish Soneja

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Komal Singh

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Netto George

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Neeraj Nischal

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Praveen Trilangi

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Adil Rashid Khan

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Devashish Desai

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Ankit Mittal

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Bharathi Arunan

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Diksha Patidar

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Ankesh Gupta

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Arvind Kumar

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Kapil Dev Soni

All India Institute of Medical Sciences (AIIMS) - Department of Anaesthesia & Critical Care Medicine

Pankaj Jorwal

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Richa Agarwal

All India Institute of Medical Sciences (AIIMS) - Department of Anaesthesia & Critical Care Medicine

Dalim K. Baidya

All India Institute of Medical Sciences (AIIMS) - Department of Anaesthesia & Critical Care Medicine

Purva Mathur

All India Institute of Medical Sciences (AIIMS) - Department of Lab Medicine

Sushma Bhatnagar

All India Institute of Medical Sciences (AIIMS) - Department of Onco-Anesthesia & Palliative Medicine

Anjan Trikha

All India Institute of Medical Sciences (AIIMS) - Department of Anaesthesia & Critical Care Medicine

S. Rajeshwari

All India Institute of Medical Sciences (AIIMS) - Department of Anaesthesia & Critical Care Medicine

Ashutosh Biswas

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Ravindra Pandey

All India Institute of Medical Sciences (AIIMS) - Department of Biostatistics

Naveet Wig

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

Randeep Guleria

All India Institute of Medical Sciences (AIIMS) - Department of Pulmonary, Critical Care and Sleep Medicine

More...

Abstract

Background: Hydroxychloroquine(HCQ) prophylaxis has been proposed for coronavirus disease-2019(COVID-19). This prospective observational study was conducted to assess the safety and efficacy of HCQ for pre-exposure prophylaxis.

Methods: The study was conducted at All India Institute of Medical Sciences, a tertiary care hospital in New Delhi, India with dedicated COVID-19 care facilities. Asymptomatic healthcare workers(HCWs) were recruited and grouped into two based on whether they were voluntarily taking HCQ as per national guidelines. Side effects in HCQ group were graded in accordance with NCI-CTCAE version 5·0. At 3-6 weeks follow-up, groups were compared for COVID-19 exposure, symptoms development, and SARS-CoV-2 RT-PCR results. Primary outcome was incidence of adverse effects, with secondary outcome being efficacy in preventing COVID-19.

Findings: Among 334 participants recruited, 202(60·5%) were males and the mean age was 31±6·5 years. HCQ prophylaxis was initiated by 248(74·2%); those working in COVID-19 care areas were more likely to initiate voluntary prophylaxis. After loading dose, 7(2·8%) reported grade 2, and 1(0·4%) grade 3 adverse effects. Discontinuation of HCQ due to side effects was reported in 11(4·4%) participants. Electrocardiogram was done in 50(20·2%) participants on HCQ, no abnormalities were noted. A total of 68(27·4%) among those taking and 49(56·9%) among those not taking HCQ were tested for SARS-CoV-2 due to influenza-like symptoms or significant exposure. Among all participants, 7(2·2%, 95% CI 0·6-3·9) developed COVID-19 at median 5 weeks follow-up. In the group taking HCQ, 2(0·8%) tested positive compared to 5(5·8%) in the group not taking HCQ (p=0·013). Odds ratio with HCQ intake was 0·13(95% CI 0·02-0·85, p=0·03) and the number needed to treat was 26.

Interpretation: HCQ is safe at the recommended dose for pre-exposure prophylaxis of COVID-19. HCQ chemoprophylaxis may decrease COVID-19 incidence; randomized controlled trial is required to validate findings.

Funding Statement: All India Institute of Medical Sciences intramural fund.

Declaration of Interests: All authors declare that there is no conflict of competing interest. Dr. Soneja has nothing to disclose.

Ethics Approval Statement: Ethical clearance was obtained from the Institute Ethics Committee.

Keywords: Hydroxychloroquine; COVID-19; SARS CoV-2; Pre-exposure Prophylaxis; Healthcare Workers; India

Suggested Citation

Kadnur, Harshith B. and Aggarwal, Anivita and Soneja, Manish and Singh, Komal and George, Netto and Nischal, Neeraj and Trilangi, Praveen and Khan, Adil Rashid and Desai, Devashish and Mittal, Ankit and Arunan, Bharathi and Patidar, Diksha and Gupta, Ankesh and Kumar, Arvind and Soni, Kapil Dev and Jorwal, Pankaj and Agarwal, Richa and Baidya, Dalim K. and Mathur, Purva and Bhatnagar, Sushma and Trikha, Anjan and Rajeshwari, S. and Biswas, Ashutosh and Pandey, Ravindra and Wig, Naveet and Guleria, Randeep, Hydroxychloroquine Pre-Exposure Prophylaxis for COVID-19 Among Healthcare Workers: Initial Experience from India (6/3/2020). Available at SSRN: https://ssrn.com/abstract=3622350 or http://dx.doi.org/10.2139/ssrn.3622350

Harshith B. Kadnur

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Anivita Aggarwal

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Manish Soneja (Contact Author)

All India Institute of Medical Sciences (AIIMS) - Department of Medicine ( email )

New Delhi
India
9013074717 (Phone)

Komal Singh

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Netto George

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Neeraj Nischal

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Praveen Trilangi

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Adil Rashid Khan

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Devashish Desai

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Ankit Mittal

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Bharathi Arunan

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Diksha Patidar

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Ankesh Gupta

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Arvind Kumar

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Kapil Dev Soni

All India Institute of Medical Sciences (AIIMS) - Department of Anaesthesia & Critical Care Medicine

New Delhi
India

Pankaj Jorwal

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Richa Agarwal

All India Institute of Medical Sciences (AIIMS) - Department of Anaesthesia & Critical Care Medicine

New Delhi
India

Dalim K. Baidya

All India Institute of Medical Sciences (AIIMS) - Department of Anaesthesia & Critical Care Medicine

New Delhi
India

Purva Mathur

All India Institute of Medical Sciences (AIIMS) - Department of Lab Medicine

Aurobindo Marg
Ansari Nagar East
New Delhi, New Delhi 110029
India

Sushma Bhatnagar

All India Institute of Medical Sciences (AIIMS) - Department of Onco-Anesthesia & Palliative Medicine

New Delhi
India

Anjan Trikha

All India Institute of Medical Sciences (AIIMS) - Department of Anaesthesia & Critical Care Medicine

New Delhi
India

S. Rajeshwari

All India Institute of Medical Sciences (AIIMS) - Department of Anaesthesia & Critical Care Medicine

New Delhi
India

Ashutosh Biswas

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Ravindra Pandey

All India Institute of Medical Sciences (AIIMS) - Department of Biostatistics ( email )

India

Naveet Wig

All India Institute of Medical Sciences (AIIMS) - Department of Medicine

New Delhi
India

Randeep Guleria

All India Institute of Medical Sciences (AIIMS) - Department of Pulmonary, Critical Care and Sleep Medicine

Ansari Nagar
India

Click here to go to TheLancet.com

Paper statistics

Abstract Views
304
Downloads
56