Trials (Jan 2020)
Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial
- Yaseen M. Arabi,
- Ayed Y. Asiri,
- Abdullah M. Assiri,
- Hani A. Aziz Jokhdar,
- Adel Alothman,
- Hanan H. Balkhy,
- Sameera AlJohani,
- Shmeylan Al Harbi,
- Suleiman Kojan,
- Majed Al Jeraisy,
- Ahmad M. Deeb,
- Ziad A. Memish,
- Sameeh Ghazal,
- Sarah Al Faraj,
- Fahad Al-Hameed,
- Asim AlSaedi,
- Yasser Mandourah,
- Ghaleb A. Al Mekhlafi,
- Nisreen Murad Sherbeeni,
- Fatehi Elnour Elzein,
- Abdullah Almotairi,
- Ali Al Bshabshe,
- Ayman Kharaba,
- Jesna Jose,
- Abdulrahman Al Harthy,
- Mohammed Al Sulaiman,
- Ahmed Mady,
- Robert A. Fowler,
- Frederick G. Hayden,
- Abdulaziz Al-Dawood,
- Mohamed Abdelzaher,
- Wail Bajhmom,
- Mohamed A. Hussein,
- and the Saudi Critical Care Trials group
Affiliations
- Yaseen M. Arabi
- College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Ayed Y. Asiri
- Prince Mohammed bin Abdulaziz Hospital
- Abdullah M. Assiri
- Infection Prevention and Control, Assistant Deputy Minister, Preventive Health, Ministry of Health
- Hani A. Aziz Jokhdar
- Deputy Minister for Public Health, Ministry of Health
- Adel Alothman
- College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Hanan H. Balkhy
- College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Sameera AlJohani
- College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Shmeylan Al Harbi
- College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Suleiman Kojan
- College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Majed Al Jeraisy
- College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Ahmad M. Deeb
- King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Research Office
- Ziad A. Memish
- Prince Mohammed bin Abdulaziz Hospital, Ministry of Health & College of Medicine, Alfaisal University
- Sameeh Ghazal
- Prince Mohammed bin Abdulaziz Hospital
- Sarah Al Faraj
- Prince Mohammed bin Abdulaziz Hospital
- Fahad Al-Hameed
- College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Asim AlSaedi
- College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Yasser Mandourah
- Military Medical Services, Ministry of Defense, Prince Sultan Military Medical City
- Ghaleb A. Al Mekhlafi
- Department of Intensive Care Services, Prince Sultan Military Medical City
- Nisreen Murad Sherbeeni
- Infectious Diseases Division, Prince Sultan Military Medical City
- Fatehi Elnour Elzein
- Infectious Diseases Division, Prince Sultan Military Medical City
- Abdullah Almotairi
- Department of Critical Care Medicine, King Fahad Medical City
- Ali Al Bshabshe
- Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital
- Ayman Kharaba
- Department of Critical Care, King Fahad Hospital, Ohoud Hospital
- Jesna Jose
- Department Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Abdulrahman Al Harthy
- Intensive Care Unit, King Saud Medical City
- Mohammed Al Sulaiman
- Infectious Disease, King Saud Medical City
- Ahmed Mady
- Intensive Care Department, King Saud Medical City
- Robert A. Fowler
- Institute of Health Policy Management and Evaluation, University of Toronto
- Frederick G. Hayden
- International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia School of Medicine
- Abdulaziz Al-Dawood
- College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
- Mohamed Abdelzaher
- Critical Care Medicine Department, King Abdullah Medical Complex
- Wail Bajhmom
- Internal Medicine Department, King Fahad General Hospital, Ministry of Health
- Mohamed A. Hussein
- Ministry of the National Guard - Health Affairs
- and the Saudi Critical Care Trials group
- DOI
- https://doi.org/10.1186/s13063-019-3846-x
- Journal volume & issue
-
Vol. 21,
no. 1
pp. 1 – 8
Abstract
Abstract The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. The MIRACLE trial is designed as a recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The aim of this article is to describe the statistical analysis plan for the MIRACLE trial. The primary outcome is 90-day mortality. The primary analysis will follow the intention-to-treat principle. The MIRACLE trial is the first randomized controlled trial for MERS treatment. Trial registration ClinicalTrials.gov, NCT02845843. Registered on 27 July 2016.
Keywords
