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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.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 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.
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 PaperHCQAll
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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' 'https://doi.org/10.1016/j.bbrc.2004.04.083.', 'journal-title': 'Biochem Biophys Res Commun'}, { 'issue': '3', 'key': '5675_CR17', 'doi-asserted-by': 'publisher', 'first-page': '147', 'DOI': '10.1016/S1473-3099(05)70022-0', 'volume': '5', 'author': 'DA Groneberg', 'year': '2005', 'unstructured': 'Groneberg DA, Poutanen SM, Low DE, Lode H, Welte T, Zabel P. Treatment ' 'and vaccines for severe acute respiratory syndrome. Lancet Infect Dis. ' '2005;5(3):147–55. https://doi.org/10.1016/S1473-3099(05)70022-0.', 'journal-title': 'Lancet Infect Dis'}, { 'issue': '1', 'key': '5675_CR18', 'doi-asserted-by': 'publisher', 'first-page': '80', 'DOI': '10.1093/infdis/jiu396', 'volume': '211', 'author': 'J Mair-Jenkins', 'year': '2015', 'unstructured': 'Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw F-M, Lim ' 'WS, et al. The effectiveness of convalescent plasma and hyperimmune ' 'immunoglobulin for the treatment of severe acute respiratory infections ' 'of viral etiology: a systematic review and exploratory meta-analysis. J ' 'Infect Dis. 2015;211(1):80–90. https://doi.org/10.1093/infdis/jiu396.', 'journal-title': 'J Infect Dis'}, { 'key': '5675_CR19', 'volume-title': 'Treatment of MERS-CoV: information for clinicians. Clinical ' 'decision-making support for treatment of MERS-CoV patients [Internet]', 'author': 'Public Health England', 'year': '2017', 'unstructured': 'Public Health England. Treatment of MERS-CoV: information for ' 'clinicians. Clinical decision-making support for treatment of MERS-CoV ' 'patients [Internet]. 2017. [cited 2020 Apr 5]. Available from: ' 'https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/638628/MERS_CoV_guidance_for_clinicians.pdf.'}, { 'issue': '6', 'key': '5675_CR20', 'doi-asserted-by': 'publisher', 'first-page': '606', 'DOI': '10.1016/j.jinf.2013.09.029', 'volume': '67', 'author': 'JFW Chan', 'year': '2013', 'unstructured': 'Chan JFW, Chan K-H, Kao RYT, To KKW, Zheng B-J, Li CPY, et al. ' 'Broad-spectrum antivirals for the emerging Middle East respiratory ' 'syndrome coronavirus. J Infect. 2013;67(6):606–16. ' 'https://doi.org/10.1016/j.jinf.2013.09.029.', 'journal-title': 'J Infect'}, { 'key': '5675_CR21', 'doi-asserted-by': 'publisher', 'first-page': '9', 'DOI': '10.1016/j.antiviral.2014.12.011', 'volume': '115', 'author': 'K-W Cheng', 'year': '2015', 'unstructured': 'Cheng K-W, Cheng S-C, Chen W-Y, Lin M-H, Chuang S-J, Cheng I-H, et al. ' 'Thiopurine analogs and mycophenolic acid synergistically inhibit the ' 'papain-like protease of Middle East respiratory syndrome coronavirus. ' 'Antivir Res. 2015;115:9–16. ' 'https://doi.org/10.1016/j.antiviral.2014.12.011.', 'journal-title': 'Antivir Res'}, { 'issue': '16', 'key': '5675_CR22', 'doi-asserted-by': 'publisher', 'first-page': '8416', 'DOI': '10.1128/JVI.00948-15', 'volume': '89', 'author': 'Y Wang', 'year': '2015', 'unstructured': 'Wang Y, Sun Y, Wu A, Xu S, Pan R, Zeng C, et al. Coronavirus nsp10/nsp16 ' 'methyltransferase can be targeted by nsp10-derived peptide in vitro and ' 'in vivo to reduce replication and pathogenesis. J Virol. ' '2015;89(16):8416–27. https://doi.org/10.1128/JVI.00948-15.', 'journal-title': 'J Virol'}, { 'key': '5675_CR23', 'unstructured': 'Interim clinical guidance for adults with suspected or confirmed Covid- ' '19 in Belgium. 2020. Version 6 [Internet]. [cited 2020 Apr 2]. Available ' 'from: ' 'https://epidemio.wiv-isp.be/ID/Documents/Covid19/COVID-19_InterimGuidelines_Treatment_ENG.pdf.'}, { 'issue': '1', 'key': '5675_CR24', 'doi-asserted-by': 'publisher', 'first-page': '72', 'DOI': '10.5582/bst.2020.01047', 'volume': '14', 'author': 'J Gao', 'year': '2020', 'unstructured': '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.', 'journal-title': 'Biosci Trends'}, { 'key': '5675_CR25', 'unstructured': 'Chen J, Liu D, Liu L, Liu P, Xu Q, Xia L, et al. A pilot study of ' 'hydroxychloroquine in treatment of patients with common coronavirus ' 'disease-19 (COVID-19). J Zhejiang Univ. 2020; [cited 2020 Mar 25]. ' 'Available from: ' 'http://subject.med.wanfangdata.com.cn/UpLoad/Files/202003/43f8625d4dc74e42bbcf24795de1c77c.pdf.'}, { 'key': '5675_CR26', 'doi-asserted-by': 'crossref', 'unstructured': 'Gautret P, Lagier J, Parola P, et al. Clinical and microbiological ' 'effect of a combination of hydroxychloroquine and azithromycin in 80 ' 'COVID-19 patients with at least a six-day follow up: an observational ' 'study [Internet]. [cited 2020 Apr 2]. Available from: ' 'https://www.mediterranee-infection.com/wp-content/uploads/2020/03/COVID-IHU-2-1.pdf.', 'DOI': '10.1016/j.tmaid.2020.101663'}, { 'key': '5675_CR27', 'unstructured': 'Soto Alonso. Nigeria has chloroquine poisonings after Trump praised ' 'drug. Bloomberg.com [Internet]. 2020. [cited 2020 Mar 25]. Available ' 'from: ' 'https://www.bloomberg.com/news/articles/2020-03-21/nigeria-reports-chloroquine-poisonings-after-trump-praised-drug.'}, { 'key': '5675_CR28', 'unstructured': 'Nigeria Centre for Disease Control. NCDC on Twitter: “#FactsNotFear @WHO ' 'has NOT approved the use of chloroquine for #COVID19 management. ' 'Scientists are working hard to confirm the safety of several drugs for ' 'this disease. Please DO NOT engage in self-medication. This will cause ' 'harm and can lead to death. #COVID19Nigeria https://t.co/K6kljq0VtW” / ' 'Twitter [Internet]. Twitter. [cited 2020 Mar 25]. Available from: ' 'https://twitter.com/ncdcgov/status/1241006420419641345.'}, { 'issue': '11', 'key': '5675_CR29', 'doi-asserted-by': 'publisher', 'first-page': '722', 'DOI': '10.1016/S1473-3099(03)00806-5', 'volume': '3', 'author': 'A Savarino', 'year': '2003', 'unstructured': 'Savarino A, Boelaert JR, Cassone A, Majori G, Cauda R. Effects of ' 'chloroquine on viral infections: an old drug against today’s diseases? ' 'Lancet Infect Dis. 2003;3(11):722–7. ' 'https://doi.org/10.1016/S1473-3099(03)00806-5.', 'journal-title': 'Lancet Infect Dis'}, { 'issue': '1', 'key': '5675_CR30', 'doi-asserted-by': 'publisher', 'first-page': '6', 'DOI': '10.1186/1742-4690-4-6', 'volume': '4', 'author': 'MA Naarding', 'year': '2007', 'unstructured': 'Naarding MA, Baan E, Pollakis G, Paxton WA. Effect of chloroquine on ' 'reducing HIV-1 replication in vitro and the DC-SIGN mediated transfer of ' 'virus to CD4+ T-lymphocytes. Retrovirology. 2007;4(1):6. ' 'https://doi.org/10.1186/1742-4690-4-6.', 'journal-title': 'Retrovirology.'}, { 'issue': '1', 'key': '5675_CR31', 'doi-asserted-by': 'publisher', 'first-page': '264', 'DOI': '10.1016/j.bbrc.2004.08.085', 'volume': '323', 'author': 'E Keyaerts', 'year': '2004', 'unstructured': 'Keyaerts E, Vijgen L, Maes P, Neyts J, Van Ranst M. In vitro inhibition ' 'of severe acute respiratory syndrome coronavirus by chloroquine. Biochem ' 'Biophys Res Commun. 2004;323(1):264–8. ' 'https://doi.org/10.1016/j.bbrc.2004.08.085.', 'journal-title': 'Biochem Biophys Res Commun'}, { 'issue': '2', 'key': '5675_CR32', 'doi-asserted-by': 'publisher', 'first-page': '300', 'DOI': '10.1038/cr.2012.165', 'volume': '23', 'author': 'Y Yan', 'year': '2013', 'unstructured': 'Yan Y, Zou Z, Sun Y, Li X, Xu K-F, Wei Y, et al. Anti-malaria drug ' 'chloroquine is highly effective in treating avian influenza A H5N1 virus ' 'infection in an animal model. Cell Res. 2013;23(2):300–2. ' 'https://doi.org/10.1038/cr.2012.165.', 'journal-title': 'Cell Res'}, { 'key': '5675_CR33', 'doi-asserted-by': 'publisher', 'unstructured': 'Hu TY, Frieman M, Wolfram J. Insights from nanomedicine into chloroquine ' 'efficacy against COVID-19. Nat Nanotechnol. 2020;(4):1–3. ' 'https://doi.org/10.1038/s41565-020-0674-9.', 'DOI': '10.1038/s41565-020-0674-9'}, { 'issue': '1', 'key': '5675_CR34', 'doi-asserted-by': 'publisher', 'first-page': '69', 'DOI': '10.1186/1743-422X-2-69', 'volume': '2', 'author': 'MJ Vincent', 'year': '2005', 'unstructured': 'Vincent MJ, Bergeron E, Benjannet S, Erickson BR, Rollin PE, Ksiazek TG, ' 'et al. Chloroquine is a potent inhibitor of SARS coronavirus infection ' 'and spread. Virol J. 2005;2(1):69. ' 'https://doi.org/10.1186/1743-422X-2-69.', 'journal-title': 'Virol J'}, { 'issue': '1A', 'key': '5675_CR35', 'doi-asserted-by': 'publisher', 'first-page': '40', 'DOI': '10.1016/0002-9343(83)91269-X', 'volume': '75', 'author': 'AH Mackenzie', 'year': '1983', 'unstructured': 'Mackenzie AH. Dose refinements in long-term therapy of rheumatoid ' 'arthritis with antimalarials. Am J Med. 1983;75(1A):40–5. ' 'https://doi.org/10.1016/0002-9343(83)91269-X.', 'journal-title': 'Am J Med'}, { 'key': '#cr-split#-5675_CR36.1', 'doi-asserted-by': 'crossref', 'unstructured': 'Nicastri E, Petrosillo N, Bartoli TA, Lepore L, Mondi A, Palmieri F, et ' 'al. National Institute for the Infectious Diseases "L. Spallanzani", ' 'IRCCS. Recommendations for COVID-19 clinical management. Infect Dis Rep. ' '2020;12', 'DOI': '10.4081/idr.2020.8543'}, { 'key': '#cr-split#-5675_CR36.2', 'unstructured': '(1) [cited 2020 Apr 2]. Available from: ' 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7097833/.'}, { 'key': '5675_CR37', 'unstructured': 'Multicenter collaboration group of Department of Science and Technology ' 'of Guangdong Province and Health Commission of Guangdong Province for ' 'chloroquine in the treatment of novel coronavirus pneumonia. [Expert ' 'consensus on chloroquine phosphate for the treatment of novel ' 'coronavirus pneumonia]. Zhonghua Jie He He Hu Xi Za Zhi Zhonghua Jiehe ' 'He Huxi Zazhi Chin J Tuberc Respir Dis. 2020;43(3):185–8.'}, { 'issue': '19', 'key': '5675_CR38', 'doi-asserted-by': 'publisher', 'first-page': '1787', 'DOI': '10.1056/NEJMoa2001282', 'volume': '382', 'author': 'B Cao', 'year': '2020', 'unstructured': 'Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, et al. A trial of ' 'lopinavir–ritonavir in adults hospitalized with severe Covid-19. N Engl ' 'J Med. 2020;382(19):1787–99. https://doi.org/10.1056/NEJMoa2001282. ' 'https://doi.org/10.1056/NEJMoa2001282.', 'journal-title': 'N Engl J Med'}, { 'issue': '1', 'key': '5675_CR39', 'doi-asserted-by': 'publisher', 'first-page': '69', 'DOI': '10.1016/j.jcv.2004.03.003', 'volume': '31', 'author': 'F Chen', 'year': '2004', 'unstructured': 'Chen F, Chan KH, Jiang Y, Kao RY, Lu HT, Fan KW, et al. In vitro ' 'susceptibility of 10 clinical isolates of SARS coronavirus to selected ' 'antiviral compounds. J Clin Virol. 2004;31(1):69–75. ' 'https://doi.org/10.1016/j.jcv.2004.03.003.', 'journal-title': 'J Clin Virol'}, { 'issue': '27', 'key': '5675_CR40', 'doi-asserted-by': 'publisher', 'first-page': '10012', 'DOI': '10.1073/pnas.0403596101', 'volume': '101', 'author': 'C-Y Wu', 'year': '2004', 'unstructured': 'Wu C-Y, Jan J-T, Ma S-H, Kuo CJ, Juan HF, Cheng YSE, et al. Small ' 'molecules targeting severe acute respiratory syndrome human coronavirus. ' 'Proc Natl Acad Sci U S A. 2004;101(27):10012–7. ' 'https://doi.org/10.1073/pnas.0403596101.', 'journal-title': 'Proc Natl Acad Sci U S A'}, { 'key': '5675_CR41', 'unstructured': 'WHO Director-General’s opening remarks at the media briefing on ' 'COVID-19. 2020. [Internet]. [cited 2020 Mar 25]. Available from: ' 'https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19%2D%2D-18-march-2020.'}, { 'key': '5675_CR42', 'volume-title': 'Master Protocol. A multi-centre, adaptive, randomized, double-blind, ' 'placebo-controlled clinical trial of the safety and efficacy of ' 'investigational therapeutics for the treatment of COVID-19 in ' 'hospitalized patients. Version Number: 2.0', 'author': 'World Health Organization', 'year': '2020', 'unstructured': 'World Health Organization. Master Protocol. A multi-centre, adaptive, ' 'randomized, double-blind, placebo-controlled clinical trial of the ' 'safety and efficacy of investigational therapeutics for the treatment of ' 'COVID-19 in hospitalized patients. Version Number: 2.0. 2020.'}, { 'key': '5675_CR43', 'unstructured': 'World Health Organization. WHO R&D Blueprint. Novel coronavirus COVID-19 ' 'therapeutic trial. 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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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment 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 and WCH provide treatment protocols.
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