Top

Published in:

Open Access 01-12-2020 | Post-Exposure Prophylaxis | Study protocol

Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial

Authors: Madunil A. Niriella, Dileepa S. Ediriweera, Arjuna P. De Silva, Ranjan Premarathne, Priyantha Balasooriya, Kaluthanthri D. Duminda, Neelika G. Malavige, Kamani Wanigasuriya, Sarath Lekamwasam, Senanayake A. Kularathne, Sisira Siribaddana, Hithanadura J. de Silva, Saroj Jayasinghe

Published in: Trials | Issue 1/2020

Abstract

Background

The first case of a coronavirus 2019 (COVID-19) infection in a Sri Lankan was reported on March 11, 2020. The situation in Sri Lanka changed with the rapid increase of personnel contracting COVID-19 in a naval base camp that housed more than 4000 people. This provided a unique opportunity to study the effectiveness of hydroxychloroquine (HCQ) for post-exposure prophylaxis (PEP), while taking stringent, non-pharmacologic, public health measures to prevent spread. Our aim is to study the effectiveness and safety of HCQ for PEP among naval personnel with exposure to COVID-19-positive patients.

Methods/design

This is a placebo-controlled, randomized, clinical trial carried out in the naval base camp and quarantine centers of the Sri Lanka Navy, Ministry of Defense, Sri Lanka. Navy personnel who are exposed to a patient with confirmed COVID-19 infection but test negative for the virus on reverse real-time polymerase chain reaction (rRT-PCR) at recruitment will be randomized, 200 to each arm, to receive HCQ or placebo and monitored for the development of symptoms or rRT-PCR positivity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus for 14 days.

Discussion

This trial will provide high-quality evidence of the effectiveness and safety of HCQ as PEP for COVID-19. The study design is unique due to the circumstances of the outbreak in a confined area among otherwise healthy adults, at a relatively early stage of its spread.

Trial registration

Sri Lanka Clinical Trials Registry (SLCTR) SLCTR/2020/011. Registered on 04 May 2020

Cevik M, Bamford C, Ho A. COVID-19 pandemic – a focused review for clinicians. Clin Microbiol Infect. 2020;26(7):842–7.CrossRef

Gao J, Tian Z, Yang X. Breakthrough: chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020;14(1):72–3. https://doi.org/10.5582/bst.2020.01047.

Schrezenmeier E, Dörner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol. 2020;16(3):155–66. https://doi.org/10.1038/s41584-020-0372-x.

Liu J, Cao R, Xu M, et al. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020;6:16. https://doi.org/10.1038/s41421-020-0156-0.CrossRef

Wang M, Cao R, Zhang L, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020;30(3):269–71. https://doi.org/10.1038/s41422-020-0282-0.

Das SK, Pareek A, Mathur DS, et al. Efficacy and safety of hydroxychloroquine sulphate in rheumatoid arthritis: a randomized, double-blind, placebo controlled clinical trial--an Indian experience. Curr Med Res Opin. 2007;23(9):2227–34. https://doi.org/10.1185/030079907X219634.CrossRef

Hydroxychloroquine post exposure prophylaxis for coronavirus disease (COVID-19). https://clinicaltrials.gov/ct2/show/NCT04318444. Accessed 31 July 2020.

Safety and Efficacy of Hydroxychloroquine for at Risk Population (SHARP) against COVID-19 (SHARP COVID-19). https://clinicaltrials.gov/ct2/show/NCT04342156. Accessed 31 July 2020.

Chloroquine/hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting (COPCOV). https://clinicaltrials.gov/ct2/show/NCT04303507. Accessed 31 July 2020.

10.

Post-exposure prophylaxis/preemptive therapy for SARS-Coronavirus-2 (COVID-19 PEP). https://clinicaltrials.gov/ct2/show/NCT04308668. Accessed 31 July 2020.

11.

National Taskforce for COVID-19. Advisory on the use of hydroxy-chloroquine as prophylaxis for SARS-CoV-2 infection. 2020. https://www.mohfw.gov.in/pdf/AdvisoryontheuseofHydroxychloroquinasprophylaxisforSARSCoV2infection.pdf. Accessed 7 May 2020.

12.

Shelar J. BMC to try out hydroxychloroquine as prophylaxis in Dharavi. Worli Koliwada: The Hindu; 2020. https://www.thehindu.com/news/cities/mumbai/bmc-to-try-out-hydroxychloroquine-as-prophylaxis-in-dharavi-worli-koliwada/article31335133.ece. Accessed 7 May 2020.

13.

Hydroxychloroquine post exposure prophylaxis for coronavirus disease (COVID-19). https://clinicaltrials.gov/ct2/show/NCT04318444. Accessed 7 May 2020.

14.

Safety and Efficacy of Hydroxychloroquine for at Risk Population (SHARP) against COVID-19 (SHARP COVID-19). https://clinicaltrials.gov/ct2/show/NCT04342156. Accessed 7 May 2020.

15.

Chloroquine/hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting (COPCOV). https://clinicaltrials.gov/ct2/show/NCT04303507. Accessed 7 May 2020.

16.

Post-exposure prophylaxis/preemptive therapy for SARS-Coronavirus-2 (COVID-19 PEP). https://clinicaltrials.gov/ct2/show/NCT04308668. Accessed 7 May 2020.

17.

WHO. Laboratory testing for coronavirus disease (COVID-19) in suspected human cases. https://apps.who.int/iris/rest/bitstreams/1272454/retrieve. Accessed 7 May 2020.

Title: Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial
Authors: Madunil A. Niriella
Dileepa S. Ediriweera
Arjuna P. De Silva
Ranjan Premarathne
Priyantha Balasooriya
Kaluthanthri D. Duminda
Neelika G. Malavige
Kamani Wanigasuriya
Sarath Lekamwasam
Senanayake A. Kularathne
Sisira Siribaddana
Hithanadura J. de Silva
Saroj Jayasinghe
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Post-Exposure Prophylaxis
SARS-CoV-2
COVID-19
Hydroxychloroquine
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04659-7

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2020

The clinical and cost-effectiveness of a Victim Improvement Package (VIP) for the reduction of chronic symptoms of depression or anxiety in older victims of common crime (the VIP trial): study protocol for a randomised controlled trial

Swiss chocolate and free beverages to increase the motivation for scientific work amongst residents: a prospective interventional study in a non-academic teaching hospital in Switzerland

An efficacy and safety study of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation (PLICTS): study protocol for a prospective randomized controlled trial

Cognitive-behavioral family therapy as psychoeducation for adolescents with high-functioning autism spectrum disorders: Aware and Care for my Autistic Traits (ACAT) program study protocol for a pragmatic multisite randomized controlled trial

Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial

Examining the benefits and harms of Alzheimer’s disease screening for family members of older adults: study protocol for a randomized controlled trial