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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

Abayomi et al., Trials, doi:10.1186/s13063-021-05675-x, LACCTT, PACTR202004801273802

Dec 2021

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HCQ for COVID-19

1st treatment shown to reduce risk in March 2020

^*, now with p < 0.00000000001 from 411 studies, recognized in 46 countries.

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

No treatment is 100% effective. Protocols combine treatments. ^* >10% efficacy, ≥3 studies.

4,500+ studies for 81 treatments. c19hcq.org

Estimated 800 patient HCQ early treatment RCT with results not reported over 2 years after estimated completion. Registry updates indicate recruiting started in June 2020 with estimated completion in December 2020. In August 2021 the registry was updated to indicate the trial had been "stopped early/terminated".

38 HCQ RCTs have results missing long after expected1-38
The trials report a total of 25,399 patients, with 12 trials having actual enrollment of 8,139, and the remainder estimated.

Important missing comments or errors? Let us know.

1. Genton et al., #StayHome: Early Hydroxychloroquine to Reduce Secondary Hospitalisation and Household Transmission in COVID-19 (#StayHome), NCT04385264, clinicaltrials.gov/study/NCT04385264.clinicaltrials.gov.

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

3. Ghanem-Zoubi et al., Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers, NCT04438837, clinicaltrials.gov/study/NCT04438837.clinicaltrials.gov.

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.

5. White et al., Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting (COPCOV), COPCOV, NCT04303507, classic.clinicaltrials.gov/ct2/show/study/NCT04303507.clinicaltrials.gov.

6. Pineda et al., Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19 (AMBUCOV), NCT04954040, clinicaltrials.gov/study/NCT04954040.clinicaltrials.gov.

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

8. Al Ansari et al., Post Exposure Prophylaxis in Healthcare Workers Exposed to COVID-19 Patients (HCQ-COVID19), NCT04437693, clinicaltrials.gov/study/NCT04437693.clinicaltrials.gov.

9. 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.

10. 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.

11. 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.

12. 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.

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

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

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

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

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

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

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

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

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

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

23. 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/NCT04355052.clinicaltrials.gov.

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

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

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

27. 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=ACTRN12620000501943.org.au.

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

29. Sarwar (B) et al., PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds (PRECISE), NCT04351191, clinicaltrials.gov/study/NCT04351191.clinicaltrials.gov.

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

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

32. 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/NCT04377646.clinicaltrials.gov.

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

34. 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.

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

36. Butler et al., PRINCIPLE: A clinical trial evaluating treatments for suspected and confirmed COVID-19 for recovery at home, PRINCIPLE, www.isrctn.com/ISRCTN86534580.isrctn.com.

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

38. Kim et al., Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19), NCT04307693, clinicaltrials.gov/study/NCT04438837.clinicaltrials.gov.

Abayomi et al., 4 Dec 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Nigeria, peer-reviewed, trial PACTR202004801273802 (LACCTT). Contact: sea.anya@gmail.com (corresponding author), olusegun.ogboye@lagosstate.gov.ng.

This Paper HCQ All

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

A Abayomi, A Osibogun, O Ezechi, K Wright, B Ola, O Ojo, Y Kuyinu, E Zamba, H Abdur-Razzaq, O A Erinoso, S E Anya

Trials, doi:10.1186/s13063-021-05675-x

Background: The coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that was first identified in Wuhan, Hubei, China, in December 2019. It was recognized as a pandemic by the World Health Organization on 11 March 2020. Outbreak forecasting and mathematical modelling suggest that these numbers will continue to rise. Early identification of effective remedies that can shorten the duration and severity of illness is critical for Lagos State, which is the epi-centre of the disease in Nigeria. Methods: This is a multi-centre, randomized, double-blind placebo-controlled superiority trial. The study investigates the efficacy of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir added on to standard of care compared to standard of care only in patients with COVID-19 disease. The primary outcome is the clinical status of patients measured using a 7-point ordinal scale at day 15. Research participants and clinicians will be blinded to the allocated intervention. Outcome measures will be directly assessed by clinicians. Statistical analysis will be done by a team blinded to the identity and allocation of research participants. Data analysis will follow intention-to-treat methods, using R software. Discussion: The current study is of strategic importance for Lagos State in potentially curbing the health, social and economic burden of COVID-19 disease. Should the current study demonstrate that either of the three intervention drugs is more efficacious than standard therapy alone, the State Ministry of Health will develop an evidence-based guideline for the management of COVID-19 in Lagos State. The findings will also be shared nationally and with other states which may lead to a standardized national guideline for the treatment of COVID-19 in Nigeria.

Supplementary Information The online version contains supplementary material available at https://doi. org/10.1186/s13063-021-05675-x. Additional file 1. Research Consent form. Additional file 2. Case Reporting Forms. Additional file 3. DSMB Charter. Authors' contributions {31b} All authors contributed to the design of the study and approved the final version. AO, KW, BO, EZ, OAE and SEA conceived the study; AS, OE, KW and YK led on ethics, monitoring and regulatory compliance; OO contributed to the selection of doses of chloroquine and hydroxychloroquine as well as the unblinding protocol; HA, OAE and SEA led on the study design; HA, OAE and SEA prepared the protocol. Funding {4} The Lagos State Government will provide funding for this trial. The funding body had no role in the design of the study, data collection, analysis and interpretation of data and in writing the manuscript. Declarations Ethics approval and consent to participate {24} This trial received ethical approval from the Lagos State Health Research Ethics Committee on April 7, 2020, with reference number LREC/06/10/1344. The trial also received regulatory approval from the National Agency for Food and Drug Administration and Control on May 12, 2020, with reference number NAFDAC/DER/SW/CT&D//2020/VOL.1. Participants will be provided with essential information about the trial and invited to sign an informed consent document. Consent for publication {32} Written informed consent for publication will..

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It was recognized as a pandemic by the World Health Organization on ' '11 March 2020. Outbreak forecasting and mathematical modelling suggest that these numbers ' 'will continue to rise. Early identification of effective remedies that can shorten the ' 'duration and severity of illness is critical for Lagos State, which is the epi-centre of the ' 'disease in Nigeria.\n' ' \n' ' Methods\n' ' This is a multi-centre, randomized, double-blind placebo-controlled ' 'superiority trial. The study investigates the efficacy of chloroquine phosphate, ' 'hydroxychloroquine sulphate and lopinavir/ritonavir added on to standard of care compared to ' 'standard of care only in patients with COVID-19 disease. The primary outcome is the clinical ' 'status of patients measured using a 7-point ordinal scale at day 15. Research participants ' 'and clinicians will be blinded to the allocated intervention. Outcome measures will be ' 'directly assessed by clinicians. 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[Internet]. [cited 2020 Apr 5]. Available from: ' 'https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations.'}, { 'key': '5675_CR7', 'unstructured': 'Nigeria Centre for Disease Control. Coronavirus disease (COVID-19) ' 'pandemic [Internet]. An update on COVID-19 outbreak in Nigeria for week ' '27. [cited 2020 July 20th]. Available from: ' 'https://www.ncdc.gov.ng/diseases/sitreps/?cat=14&name=An%20update%20of%20COVID-19%20outbreak%20in%20Nigeria.'}, { 'issue': '4', 'key': '5675_CR8', 'doi-asserted-by': 'publisher', 'first-page': '536', 'DOI': '10.1038/s41564-020-0695-z', 'volume': '5', 'author': 'AE Gorbalenya', 'year': '2020', 'unstructured': 'Gorbalenya AE, Baker SC, Baric RS, de Groot RJ, Drosten C, Gulyaeva AA, ' 'et al. The species severe acute respiratory syndrome-related ' 'coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. 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Synopsis. 2020; Geneva, Switzerland.'}], 'container-title': 'Trials', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1186/s13063-021-05675-x.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1186/s13063-021-05675-x/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1186/s13063-021-05675-x.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 12, 4]], 'date-time': '2021-12-04T20:10:00Z', 'timestamp': 1638648600000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05675-x'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 12]]}, 'references-count': 44, 'journal-issue': {'issue': '1', 'published-print': {'date-parts': [[2021, 12]]}}, 'alternative-id': ['5675'], 'URL': 'http://dx.doi.org/10.1186/s13063-021-05675-x', 'relation': {}, 'ISSN': ['1745-6215'], 'subject': ['Pharmacology (medical)', 'Medicine (miscellaneous)'], 'container-title-short': 'Trials', 'published': {'date-parts': [[2021, 12]]}, 'assertion': [ { 'value': '26 November 2020', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '30 September 2021', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '4 December 2021', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'This trial received ethical approval from the Lagos State Health Research ' 'Ethics Committee on April 7, 2020, with reference number LREC/06/10/1344. The ' 'trial also received regulatory approval from the National Agency for Food and ' 'Drug Administration and Control on May 12, 2020, with reference number ' 'NAFDAC/DER/SW/CT&D//2020/VOL.1. Participants will be provided with essential ' 'information about the trial and invited to sign an informed consent document.', 'order': 2, 'name': 'Ethics', 'group': { 'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate {24}'}}, { 'value': 'Written informed consent for publication will be obtained from participants.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication {32}'}}, { 'value': 'The authors declare that they have no competing interests.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests {28}'}}], 'article-number': '869'}

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