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

Abstract 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 fo...

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Autores principales:	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
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	COVID-19 SARS-CoV-2 2019-nCoV Chloroquine Hydroxychloroquine Lopinavir/ritonavir Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/b8c654b3cc2447cd9186676151bfb4fa
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spelling	oai:doaj.org-article:b8c654b3cc2447cd9186676151bfb4fa2021-12-05T12:20:10ZA 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 trial10.1186/s13063-021-05675-x1745-6215https://doaj.org/article/b8c654b3cc2447cd9186676151bfb4fa2021-12-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05675-xhttps://doaj.org/toc/1745-6215Abstract 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. Trial registration Pan African Clinical Trials Register PACTR202004801273802 . Registered prospectively on April 2, 2020A. AbayomiA. OsibogunO. EzechiK. WrightB. OlaO. OjoY. KuyinuE. ZambaH. Abdur-RazzaqO. A. ErinosoS. E. AnyaBMCarticleCOVID-19SARS-CoV-22019-nCoVChloroquineHydroxychloroquineLopinavir/ritonavirMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-18 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	COVID-19 SARS-CoV-2 2019-nCoV Chloroquine Hydroxychloroquine Lopinavir/ritonavir Medicine (General) R5-920
spellingShingle	COVID-19 SARS-CoV-2 2019-nCoV Chloroquine Hydroxychloroquine Lopinavir/ritonavir Medicine (General) R5-920 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 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
description	Abstract 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. Trial registration Pan African Clinical Trials Register PACTR202004801273802 . Registered prospectively on April 2, 2020
format	article
author	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
author_facet	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
author_sort	A. Abayomi
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMC
publishDate	2021
url	https://doaj.org/article/b8c654b3cc2447cd9186676151bfb4fa
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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

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