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

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

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

Niriella et al., Trials, doi:10.1186/s13063-020-04659-7, SLCTR/2020/011, Jul 2020

HCQ for COVID-19

1st treatment shown to reduce risk in March 2020, now with p < 0.00000000001 from 424 studies, used in 59 countries.

Lower risk for mortality, hospitalization, progression, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine treatments.

6,300+ studies for 210+ treatments. c19early.org

Meta Analysis

402 participant HCQ prophylaxis RCT with results not reported over 5 years after completion. Authors note 283 patients completed the trial, but no results are available to date.

37 HCQ RCTs have results missing long after expected1-37
The trials report a total of 20,747 patients, with 11 trials having actual enrollment of 3,487, and the remainder estimated.

Important missing comments or errors? Let us know.

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2. Hawari et al., The Potential Use of Nebulized Hydroxychloroquine for the Treatment of COVID-19, NCT05113810, clinicaltrials.gov/study/NCT05113810clinicaltrials.gov.

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4. Gagneux-Brunon et al., Acceptability of a COVID-19 pre-exposure prophylaxis trial with hydroxychloroquine in French healthcare workers during the first wave of COVID-19 pandemic, Trials, doi:10.1186/s13063-021-05329-y.biomedcentral.com, doi.org.

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6. Aston et al., Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT), NCT04334382, clinicaltrials.gov/study/NCT04334382clinicaltrials.gov.

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8. Abayomi et al., A multi-centre, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir for the treatment of COVID-19 in Lagos State: study protocol for a randomized controlled trial, Trials, doi:10.1186/s13063-021-05675-x.biomedcentral.com, doi.org.

9. González et al., Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial, Trials, doi:10.1186/s13063-020-04557-y.biomedcentral.com, doi.org.

10. Nanni et al., PROTECT Trial: A cluster-randomized study with hydroxychloroquine versus observational support for prevention or early-phase treatment of Coronavirus disease (COVID-19): A structured summary of a study protocol for a randomized controlled trial, Trials, doi:10.1186/s13063-020-04527-4.biomedcentral.com, doi.org.

11. Granados-Montiel et al., New prophylaxis regimen for SARS-CoV-2 infection in health professionals with low doses of hydroxychloroquine and bromhexine: a randomised, double-blind placebo clinical trial (ELEVATE Trial), BMJ Open, doi:10.1136/bmjopen-2020-045190.bmj.com, doi.org.

12. Kara et al., Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19, NCT04411433, clinicaltrials.gov/study/NCT04411433clinicaltrials.gov.

13. Chauffe et al., Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP), NCT04363450, clinicaltrials.gov/study/NCT04363450clinicaltrials.gov.

14. Moraes et al., Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis, NCT04384458, clinicaltrials.gov/study/NCT04384458clinicaltrials.gov.

15. Borrie et al., COVID-19 PEP- High-risk Individuals in Long-term and Specialized Care - Canada, NCT04397328, clinicaltrials.gov/study/NCT04397328clinicaltrials.gov.

16. James et al., PROLIFIC ChemoprophylaxisTrial (COVID-19), NCT04352933, clinicaltrials.gov/study/NCT04352933clinicaltrials.gov.

17. Morales-Asencio et al., Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine, NCT04400019, clinicaltrials.gov/study/NCT04400019clinicaltrials.gov.

18. Mordmüller et al., Hydroxychloroquine for COVID-19 (COV-HCQ), NCT04342221, clinicaltrials.gov/study/NCT04342221clinicaltrials.gov.

19. Gül et al., Clinical Trial For Early SARS-CoV-2 (COVID-19) Treatment, NCT04981379, clinicaltrials.gov/study/NCT04981379clinicaltrials.gov.

20. Abu-Helalah et al., Chemoprevention Clinical Trial of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis (APCC-19), NCT04597775, clinicaltrials.gov/study/NCT04597775clinicaltrials.gov.

21. Okasha et al., Hydroxychloroquine and Nitazoxanide Combination Therapy for COVID-19, NCT04361318, clinicaltrials.gov/study/NCT04361318clinicaltrials.gov.

22. Levi et al., Open Label Study to Compare Efficacy, Safety and Tolerability of Hydroxychloroquine Combined With Azithromycin Compared to Hydroxychloroquine Combined With Camostat Mesylate and to "no Treatment" in SARS CoV 2 Virus (COSTA), NCT04355052, clinicaltrials.gov/study/NCT04355052clinicaltrials.gov.

23. WellStar, Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease, NCT04429867, clinicaltrials.gov/study/NCT04429867clinicaltrials.gov.

24. Burney et al., Hydroxychloroquine Chemoprophylaxis for COVID-19 Infection in High-risk Healthcare Workers, NCT04370015, clinicaltrials.gov/study/NCT04370015clinicaltrials.gov.

25. Sow et al., Phytomedicines Versus Hydroxychloroquine as an Add on Therapy to Azithromycin in Asymptomatic Covid-19 Patients (PHYTCOVID-19), NCT04501965, clinicaltrials.gov/study/NCT04501965clinicaltrials.gov.

26. Pellegrini et al., Effectiveness of Prophylactic Hydroxychloroquine on incidence of COVID-19 infection in Front-line Health and Allied Health Care Workers: The COVID-SHIELD Trial, COVID-SHIELD, ACTRN12620000501943, www.anzctr.org.au/TrialSearch.aspx#&&conditionCode=&dateOfRegistrationFrom=&interventionDescription=&interventionCodeOperator=OR&primarySponsorType=&gender=&distance=&postcode=&pageSize=20&ageGroup=&recruitmentCountryOperator=OR&recruitmentRegion=ðicsReview=&countryOfRecruitment=Australia%7cNew+Zealand®istry=&searchTxt=ACTRN12620000501943org.au.

27. Sarwar et al., Post-Exposure Prophylaxis for Asymptomatic SARS-CoV-2 COVID-19 Patients With Choloroquine Compounds (PEACE), NCT04346667, clinicaltrials.gov/study/NCT04346667clinicaltrials.gov.

28. Sarwar (B) et al., Prophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using Choloroquine Compounds (PRECISE), NCT04351191, clinicaltrials.gov/study/NCT04351191clinicaltrials.gov.

29. Connor et al., HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial (HERO), NCT04352946, clinicaltrials.gov/study/NCT04352946clinicaltrials.gov.

30. El-Sherbiny et al., Development and Validation of "Ready-to-Use" Inhalable Forms of Hydroxychloroquine for Treatment of COVID-19, NCT04477083, clinicaltrials.gov/study/NCT04477083clinicaltrials.gov.

31. Ajili et al., A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare Workers (COVID-Milit), NCT04377646, clinicaltrials.gov/study/NCT04377646clinicaltrials.gov.

32. Mežnar et al., Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia, NCT04355026, clinicaltrials.gov/study/NCT04355026clinicaltrials.gov.

33. Niriella et al., Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial, Trials, doi:10.1186/s13063-020-04659-7.biomedcentral.com, doi.org.

34. Farooq et al., Effectiveness of Hydroxychloroquine in Covid-19 Patients (Covid), NCT04328272, clinicaltrials.gov/study/NCT04328272clinicaltrials.gov.

35. Butler et al., PRINCIPLE: A clinical trial evaluating treatments for suspected and confirmed COVID-19 for recovery at home, PRINCIPLE, www.isrctn.com/ISRCTN86534580isrctn.com.

36. Treluyer et al., Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus (PREP-COVID), PREP-COVID, NCT04344379, clinicaltrials.gov/study/NCT04344379clinicaltrials.gov.

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Niriella et al., 3 Jul 2020, Double Blind Randomized Controlled Trial, placebo-controlled, trial SLCTR/2020/011. Contact: madunil.niriella@kln.ac.lk (corresponding author).

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

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

Trials, doi:10.1186/s13063-020-04659-7

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

Ethics approval and consent to participate Ethical clearance for the study was obtained from the Ethics Review Committee (ERC) of the Faculty of Medicine, University of Kelaniya, Ragama-P/22/04/2020. Written, informed consent to participate will be obtained from all participants. Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

Cevik, Bamford, Ho, COVID-19 pandemic -a focused review for clinicians, Clin Microbiol Infect

Das, Pareek, Mathur, Efficacy and safety of hydroxychloroquine sulphate in rheumatoid arthritis: a randomized, doubleblind, placebo controlled clinical trial--an Indian experience, Curr Med Res Opin, doi:10.1185/030079907X219634

Gao, Tian, Yang, Breakthrough: chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies, Biosci Trends, doi:10.5582/bst.2020.01047

Liu, Cao, Xu, Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro, Cell Discov, doi:10.1038/s41421-020-0156-0

Schrezenmeier, Dörner, Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology, Nat Rev Rheumatol, doi:10.1038/s41584-020-0372-x

Shelar, BMC to try out hydroxychloroquine as prophylaxis in Dharavi. Worli Koliwada: The Hindu

Wang, Cao, Zhang, Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro, Cell Res, doi:10.1038/s41422-020-0282-0

Who, Laboratory testing for coronavirus disease (COVID-19) in suspected human cases

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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.\n \n Discussion\n 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.\n \n Trial registration\n Sri Lanka Clinical Trials Registry (SLCTR) SLCTR/2020/011. 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