Hydroxychloroquine plus personal protective equipment versus personal protective equipment alone for the prevention of laboratory-confirmed COVID-19 infections among healthcare workers: a multicentre, parallel-group randomised controlled trial from India
Low-dose prophylaxis RCT with low-risk healthcare workers in India, showing no significant differences. Symptomatic case results are not provided. Followup was over 6 months, however treatment ended after 3 months. 21% of patients discontinued treatment before 3 months (Table S2).
risk of progression, 196.2% higher, RR 2.96, p = 1.00, treatment 1 of 211 (0.5%), control 0 of 203 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), ICU/HDU.
risk of hospitalization, 51.9% lower, RR 0.48, p = 0.62, treatment 1 of 211 (0.5%), control 2 of 203 (1.0%), NNT 196.
risk of case, 14.2% lower, RR 0.86, p = 0.73, treatment 11 of 211 (5.2%), control 12 of 203 (5.9%), NNT 143, adjusted per study, odds ratio converted to relative risk, confirmed cases, multivariable.
risk of case, 5.7% lower, RR 0.94, p = 0.90, treatment 12 of 211 (5.7%), control 12 of 203 (5.9%), NNT 446, adjusted per study, odds ratio converted to relative risk, multivariable.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Tirupakuzhi Vijayaraghavan et al., 1 Jun 2022, Randomized Controlled Trial, India, peer-reviewed, mean age 32.1, 21 authors, study period 29 June, 2020 - 4 February, 2021, trial CTRI/2020/05/025067
Abstract: Open access
To cite: Tirupakuzhi
Vijayaraghavan BK, Jha V,
Rajbhandari D, et al.
personal protective equipment
versus personal protective
equipment alone for the
prevention of laboratory-
confirmed COVID-19 infections
among healthcare workers:
a multicentre, parallel-group
trial from India. BMJ Open
► Prepublication history and
additional supplemental material
for this paper are available
online. To view these files,
please visit the journal online
Received 24 November 2021
Accepted 13 May 2022
© Author(s) (or their
employer(s)) 2022. Re-use
permitted under CC BY-NC. No
commercial re-use. See rights
and permissions. Published by
For numbered affiliations see
end of article.
Dr Bharath Kumar Tirupakuzhi
Bharath Kumar Tirupakuzhi Vijayaraghavan ,1,2 Vivekanand Jha,2
Dorrilyn Rajbhandari,3 Sheila Nainan Myatra,4,5 Arpita Ghosh ,2
Amritendu Bhattacharya,2 Sumaiya Arfin,2 Abhinav Bassi,2
Lachlan Hugh Donaldson,3 Naomi E Hammond ,6 Oommen John,2
Rohina Joshi,7 Mallikarjuna Kunigari,2 Cynthia Amrutha,8
Syed Haider Mehdi Husaini,9 Subir Ghosh,10 Santosh Kumar Nag,11
Hari Krishnan Selvaraj,12 Viny Kantroo,13 Kamal D Shah,14
Balasubramanian Venkatesh,3,15,16 for the HOPE Investigators
Objectives To determine whether hydroxychloroquine
when used with personal protective equipment reduces
the proportion of laboratory-confirmed COVID-19 among
healthcare workers in comparison to the use of personal
protective equipment alone.
Design Multicentre, parallel-group, open-label
randomised trial. Enrolment started on 29 June 2020 and
stopped on 4 February 2021. Participants randomised in
HydrOxychloroquine Prophylaxis Evaluation were followed
for 6 months.
Setting 9 hospitals across India.
Participants Healthcare workers in an environment with
exposure to COVID-19 were randomised in a 1:1 ratio to
hydroxychloroquine plus use of personal protective equipment
or personal protective equipment alone. 886 participants were
screened and 416 randomised (213 hydroxychloroquine arm
and 203 personal protective equipment).
Intervention Participants in intervention arm received
800 mg of hydroxychloroquine on day of randomisation
and then 400 mg once a week for 12 weeks in addition
to the use of personal protective equipment. In the control
arm, participants continued to use personal protective
Main outcome Proportion of laboratory-confirmed
COVID-19 in the 6 months after randomisation.
Results Participants were young (mean age 32.1 years,
SD 9.1 years) with low-comorbid burden. 47.4% were
female. In the 6 months after randomisation (primary
analysis population=413), 11 participants assigned
to the hydroxychloroquine group and 12 participants
assigned to the standard practice group met the primary
STRENGTHS AND LIMITATIONS OF THIS STUDY
⇒ Our trial is the largest multicentre trial evaluating
hydroxychloroquine prophylaxis for COVID-19 from
a low and middle-income country setting.
⇒ The trial tested the dose of hydroxychloroquine recommended by the Indian regulatory agencies and
had the longest follow-up duration among hydroxychloroquine trials.
⇒ Our trial included a diverse set of participants, both
in terms of balance of men and women, but also in
terms of the various healthcare..
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation. FLCCC
provide treatment protocols.