Evidence map›Paper›PMID 34863267›Full record

ArticleTrials2021

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 and 1 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 45% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

A AbayomiLagos State Ministry of Health, Alausa, Ikeja, Lagos State, Nigeria.
A OsibogunLagos State Primary Health Care Board, Lagos, Nigeria.
O EzechiNigerian Institute of Medical Research, Lagos, Nigeria.
K WrightLagos State University College of Medicine, Lagos, Nigeria.
B OlaLagos State University College of Medicine, Lagos, Nigeria.
O OjoLagos State University Teaching Hospital, Lagos, Nigeria.
Y KuyinuLagos State University College of Medicine, Lagos, Nigeria.
E ZambaLagos State Health Management Agency, Lagos, Nigeria.
H Abdur-RazzaqLagos State Ministry of Health, Alausa, Ikeja, Lagos State, Nigeria.
O A ErinosoLagos State University Teaching Hospital, Lagos, Nigeria.
S E AnyaLagos State Ministry of Health, Alausa, Ikeja, Lagos State, Nigeria. sea.anya@gmail.com.ORCID http://orcid.org/0000-0002-8013-111X
Lagos State University · NGLagos State Health Service Commission · NGLagos State University Teaching Hospital · NGNigerian Institute of Medical Research · NG

Funding

Lagos State Government NA
6 · The paper itself

Abstract

backgroundThe 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.

methodsThis 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 registrationPan African Clinical Trials Register PACTR202004801273802 . Registered prospectively on April 2, 2020.

Indexed as

COVID-19 Drug TreatmentHydroxychloroquineChloroquineEquivalence Trials as TopicHumansLopinavirMulticenter Studies as TopicNigeriaRandomized Controlled Trials as TopicRitonavirSARS-CoV-2Chloroquinechloroquine diphosphateHydroxychloroquineLopinavirRitonavir2019-nCoVChloroquineCOVID-19HydroxychloroquineLagosLopinavir/ritonavirNigeriaSARS-CoV-2

Identifiers

PMID34863267
PMCPMC8642768
OpenAlexW4200102639

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.