Evidence map›Paper›PMID 29382391›Full record

ArticleTrials2018

Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.

Yaseen M Arabi, Adel Alothman, Hanan H Balkhy, Abdulaziz Al-Dawood, Sameera AlJohani, Shmeylan Al Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M Deeb, Abdullah M Assiri and 19 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 150 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
150citing papers in PubMed, 8 pooled it
29.3field-weighted citation impact, top 1% 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.

NCT02845843 phase2 / phase3completednot on this map

MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b: a Multicenter, Placebo-controlled, Double-blind Randomized Trial

TypeinterventionalSponsorKing Abdullah International Medical Research CenterRan2016 to 2020Enrolled95ConditionsMiddle East Respiratory Syndrome Coronavirus (MERS-CoV)ArmsCombination of Lopinavir /Ritonavir and Interferon beta-1b, Placebo
NCT04420260 nacompletednot on this mapstarted 2021, after this paper: background citation

Scheme of Primary Prevention of Infection by COVID-19, in Workers: Phase II Controlled Clinical Trial, to be Carried Out in Medellín-Antioquia

TypeinterventionalSponsorUnidad de Investigación Genética MolecularRan2021 to 2021Enrolled152ConditionsCOVIDArmsGroup A: oropharygeal spray and immunostimulant emulsion, Group D:Placebo oropharyngeal spray + Placebo taken PO
3 · Its place in the literature

Who cites it

150 citing papers in PubMed, 8 syntheses or guidelines pooled it, 260 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Review of trials currently testing treatment and prevention of COVID-19.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2020
    Pooled it
  7. Guideline
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. An open-label randomized controlled trial of the effect of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-β-1a and hydroxychloroquine in hospitalized patients with COVID-19.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2021
    Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Review
  18. Article
  19. Article
  20. Article

90 more citing papers are in PubMed but not listed here.

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

29 authors at 8 institutions in 4 countries.

Yaseen M ArabiCollege of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. arabi@ngha.med.sa.
Adel AlothmanCollege of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Hanan H BalkhyCollege of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Abdulaziz Al-DawoodCollege of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Sameera AlJohaniCollege of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Shmeylan Al HarbiCollege of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Suleiman KojanCollege of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Majed Al JeraisyCollege of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Ahmad M DeebCollege of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Abdullah M AssiriInfection Prevention and Control, Ministry of Health, Riyadh, Saudi Arabia.
Fahad Al-HameedCollege of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.
Asim AlSaediCollege of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.
Yasser MandourahDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Ghaleb A AlmekhlafiDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Nisreen Murad SherbeeniInfectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Fatehi Elnour ElzeinInfectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Javed MemonIntensive Care Section, Department of Medicine, King Abdulaziz Hospital, Alahsa, Saudi Arabia.
Yusri TahaDepartment of Medicine, King Abdulaziz Hospital, Alahsa, Saudi Arabia.
Abdullah AlmotairiDepartment of Critical Care Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.
Khalid A MaghrabiDepartment of Critical Care Medicine, King Faisal Specialist Hospital and Research, Riyadh, Saudi Arabia.
Ismael QushmaqDepartment of Medicine, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia.
Ali Al BshabsheDepartment of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha, Saudi Arabia.
Ayman KharabaDepartment of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah, Saudi Arabia.
Sarah ShalhoubDepartment of Medicine, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia.
Jesna JoseDepartment of Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
Robert A FowlerAMR Infection Control and Publications AIP/PED/HSE/HQ, Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Frederick G HaydenDepartment of Medicine, Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, VA, USA.
Mohamed A HusseinDepartment of Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.
And the MIRACLE trial group
King Saud bin Abdulaziz University for Health Sciences · SARiyadh Armed Forces Hospital · SAKing Faisal Specialist Hospital & Research Centre · SAKing Abdulaziz Hospital · SAKing Fahad Hospital Jeddah · SAKing Fahd Armed Forces Hospital · SAKing Fahd Medical City · SAUniversity of Toronto · CA

Funding

king Abdullah International Medical Research Center RC15/142
6 · The paper itself

Abstract

backgroundIt had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission.

methodsThe protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. DISCUSSION: This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018.

trial registrationClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

Indexed as

Antiviral AgentsCoronavirus InfectionsDouble-Blind MethodDrug CombinationsDrug Therapy, CombinationFemaleHumansInterferon beta-1bLopinavirMaleMiddle East Respiratory Syndrome CoronavirusMulticenter Studies as TopicPatient AdmissionRandomized Controlled Trials as TopicRitonavirSaudi ArabiaAntiviral AgentsDrug CombinationsInterferon beta-1bLopinavirlopinavir-ritonavir drug combinationRitonavirAntiviralClinical trialCoronavirusInterferon-β1bLopinavir/ritonavirMERSSaudi Arabia

Identifiers

PMID29382391
PMCPMC5791210
OpenAlexW2791599184

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.