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.
Identifieur interne : 000300 ( PubMed/Corpus ); précédent : 000299; suivant : 000301Treatment 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.
Auteurs : 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. HusseinSource :
- Trials [ 1745-6215 ] ; 2020.
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.
DOI: 10.1186/s13063-019-3846-x
PubMed: 31900204
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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.</title><author><name sortKey="Arabi, Yaseen M" sort="Arabi, Yaseen M" uniqKey="Arabi Y" first="Yaseen M" last="Arabi">Yaseen M. Arabi</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. arabi@ngha.med.sa.</nlm:affiliation></affiliation></author><author><name sortKey="Asiri, Ayed Y" sort="Asiri, Ayed Y" uniqKey="Asiri A" first="Ayed Y" last="Asiri">Ayed Y. Asiri</name><affiliation><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Assiri, Abdullah M" sort="Assiri, Abdullah M" uniqKey="Assiri A" first="Abdullah M" last="Assiri">Abdullah M. Assiri</name><affiliation><nlm:affiliation>Infection Prevention and Control, Assistant Deputy Minister, Preventive Health, Ministry of Health, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Aziz Jokhdar, Hani A" sort="Aziz Jokhdar, Hani A" uniqKey="Aziz Jokhdar H" first="Hani A" last="Aziz Jokhdar">Hani A. Aziz Jokhdar</name><affiliation><nlm:affiliation>Deputy Minister for Public Health, Ministry of Health, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Alothman, Adel" sort="Alothman, Adel" uniqKey="Alothman A" first="Adel" last="Alothman">Adel Alothman</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Balkhy, Hanan H" sort="Balkhy, Hanan H" uniqKey="Balkhy H" first="Hanan H" last="Balkhy">Hanan H. Balkhy</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Harbi, Shmeylan" sort="Al Harbi, Shmeylan" uniqKey="Al Harbi S" first="Shmeylan" last="Al Harbi">Shmeylan Al Harbi</name><affiliation><nlm:affiliation>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Kojan, Suleiman" sort="Kojan, Suleiman" uniqKey="Kojan S" first="Suleiman" last="Kojan">Suleiman Kojan</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Jeraisy, Majed" sort="Al Jeraisy, Majed" uniqKey="Al Jeraisy M" first="Majed" last="Al Jeraisy">Majed Al Jeraisy</name><affiliation><nlm:affiliation>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Deeb, Ahmad M" sort="Deeb, Ahmad M" uniqKey="Deeb A" first="Ahmad M" last="Deeb">Ahmad M. Deeb</name><affiliation><nlm:affiliation>King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Research Office, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Memish, Ziad A" sort="Memish, Ziad A" uniqKey="Memish Z" first="Ziad A" last="Memish">Ziad A. Memish</name><affiliation><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Ministry of Health & College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Ghazal, Sameeh" sort="Ghazal, Sameeh" uniqKey="Ghazal S" first="Sameeh" last="Ghazal">Sameeh Ghazal</name><affiliation><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Faraj, Sarah" sort="Al Faraj, Sarah" uniqKey="Al Faraj S" first="Sarah" last="Al Faraj">Sarah Al Faraj</name><affiliation><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Hameed, Fahad" sort="Al Hameed, Fahad" uniqKey="Al Hameed F" first="Fahad" last="Al-Hameed">Fahad Al-Hameed</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Alsaedi, Asim" sort="Alsaedi, Asim" uniqKey="Alsaedi A" first="Asim" last="Alsaedi">Asim Alsaedi</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Mandourah, Yasser" sort="Mandourah, Yasser" uniqKey="Mandourah Y" first="Yasser" last="Mandourah">Yasser Mandourah</name><affiliation><nlm:affiliation>Military Medical Services, Ministry of Defense, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Mekhlafi, Ghaleb A" sort="Al Mekhlafi, Ghaleb A" uniqKey="Al Mekhlafi G" first="Ghaleb A" last="Al Mekhlafi">Ghaleb A. Al Mekhlafi</name><affiliation><nlm:affiliation>Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Sherbeeni, Nisreen Murad" sort="Sherbeeni, Nisreen Murad" uniqKey="Sherbeeni N" first="Nisreen Murad" last="Sherbeeni">Nisreen Murad Sherbeeni</name><affiliation><nlm:affiliation>Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Elzein, Fatehi Elnour" sort="Elzein, Fatehi Elnour" uniqKey="Elzein F" first="Fatehi Elnour" last="Elzein">Fatehi Elnour Elzein</name><affiliation><nlm:affiliation>Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Almotairi, Abdullah" sort="Almotairi, Abdullah" uniqKey="Almotairi A" first="Abdullah" last="Almotairi">Abdullah Almotairi</name><affiliation><nlm:affiliation>Department of Critical Care Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Bshabshe, Ali" sort="Al Bshabshe, Ali" uniqKey="Al Bshabshe A" first="Ali" last="Al Bshabshe">Ali Al Bshabshe</name><affiliation><nlm:affiliation>Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Kharaba, Ayman" sort="Kharaba, Ayman" uniqKey="Kharaba A" first="Ayman" last="Kharaba">Ayman Kharaba</name><affiliation><nlm:affiliation>Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Jose, Jesna" sort="Jose, Jesna" uniqKey="Jose J" first="Jesna" last="Jose">Jesna Jose</name><affiliation><nlm:affiliation>Department Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Harthy, Abdulrahman" sort="Al Harthy, Abdulrahman" uniqKey="Al Harthy A" first="Abdulrahman" last="Al Harthy">Abdulrahman Al Harthy</name><affiliation><nlm:affiliation>Intensive Care Unit, King Saud Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Sulaiman, Mohammed" sort="Al Sulaiman, Mohammed" uniqKey="Al Sulaiman M" first="Mohammed" last="Al Sulaiman">Mohammed Al Sulaiman</name><affiliation><nlm:affiliation>Infectious Disease, King Saud Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Mady, Ahmed" sort="Mady, Ahmed" uniqKey="Mady A" first="Ahmed" last="Mady">Ahmed Mady</name><affiliation><nlm:affiliation>Intensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Fowler, Robert A" sort="Fowler, Robert A" uniqKey="Fowler R" first="Robert A" last="Fowler">Robert A. Fowler</name><affiliation><nlm:affiliation>Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Hayden, Frederick G" sort="Hayden, Frederick G" uniqKey="Hayden F" first="Frederick G" last="Hayden">Frederick G. Hayden</name><affiliation><nlm:affiliation>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, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Abdelzaher, Mohamed" sort="Abdelzaher, Mohamed" uniqKey="Abdelzaher M" first="Mohamed" last="Abdelzaher">Mohamed Abdelzaher</name><affiliation><nlm:affiliation>Critical Care Medicine Department, King Abdullah Medical Complex, Jeddah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Bajhmom, Wail" sort="Bajhmom, Wail" uniqKey="Bajhmom W" first="Wail" last="Bajhmom">Wail Bajhmom</name><affiliation><nlm:affiliation>Internal Medicine Department, King Fahad General Hospital, Ministry of Health, Jeddah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Hussein, Mohamed A" sort="Hussein, Mohamed A" uniqKey="Hussein M" first="Mohamed A" last="Hussein">Mohamed A. Hussein</name><affiliation><nlm:affiliation>Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:31900204</idno><idno type="pmid">31900204</idno><idno type="doi">10.1186/s13063-019-3846-x</idno><idno type="wicri:Area/PubMed/Corpus">000300</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000300</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">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.</title><author><name sortKey="Arabi, Yaseen M" sort="Arabi, Yaseen M" uniqKey="Arabi Y" first="Yaseen M" last="Arabi">Yaseen M. Arabi</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. arabi@ngha.med.sa.</nlm:affiliation></affiliation></author><author><name sortKey="Asiri, Ayed Y" sort="Asiri, Ayed Y" uniqKey="Asiri A" first="Ayed Y" last="Asiri">Ayed Y. Asiri</name><affiliation><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Assiri, Abdullah M" sort="Assiri, Abdullah M" uniqKey="Assiri A" first="Abdullah M" last="Assiri">Abdullah M. Assiri</name><affiliation><nlm:affiliation>Infection Prevention and Control, Assistant Deputy Minister, Preventive Health, Ministry of Health, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Aziz Jokhdar, Hani A" sort="Aziz Jokhdar, Hani A" uniqKey="Aziz Jokhdar H" first="Hani A" last="Aziz Jokhdar">Hani A. Aziz Jokhdar</name><affiliation><nlm:affiliation>Deputy Minister for Public Health, Ministry of Health, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Alothman, Adel" sort="Alothman, Adel" uniqKey="Alothman A" first="Adel" last="Alothman">Adel Alothman</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Balkhy, Hanan H" sort="Balkhy, Hanan H" uniqKey="Balkhy H" first="Hanan H" last="Balkhy">Hanan H. Balkhy</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Harbi, Shmeylan" sort="Al Harbi, Shmeylan" uniqKey="Al Harbi S" first="Shmeylan" last="Al Harbi">Shmeylan Al Harbi</name><affiliation><nlm:affiliation>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Kojan, Suleiman" sort="Kojan, Suleiman" uniqKey="Kojan S" first="Suleiman" last="Kojan">Suleiman Kojan</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Jeraisy, Majed" sort="Al Jeraisy, Majed" uniqKey="Al Jeraisy M" first="Majed" last="Al Jeraisy">Majed Al Jeraisy</name><affiliation><nlm:affiliation>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Deeb, Ahmad M" sort="Deeb, Ahmad M" uniqKey="Deeb A" first="Ahmad M" last="Deeb">Ahmad M. Deeb</name><affiliation><nlm:affiliation>King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Research Office, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Memish, Ziad A" sort="Memish, Ziad A" uniqKey="Memish Z" first="Ziad A" last="Memish">Ziad A. Memish</name><affiliation><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Ministry of Health & College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Ghazal, Sameeh" sort="Ghazal, Sameeh" uniqKey="Ghazal S" first="Sameeh" last="Ghazal">Sameeh Ghazal</name><affiliation><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Faraj, Sarah" sort="Al Faraj, Sarah" uniqKey="Al Faraj S" first="Sarah" last="Al Faraj">Sarah Al Faraj</name><affiliation><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Hameed, Fahad" sort="Al Hameed, Fahad" uniqKey="Al Hameed F" first="Fahad" last="Al-Hameed">Fahad Al-Hameed</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Alsaedi, Asim" sort="Alsaedi, Asim" uniqKey="Alsaedi A" first="Asim" last="Alsaedi">Asim Alsaedi</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Mandourah, Yasser" sort="Mandourah, Yasser" uniqKey="Mandourah Y" first="Yasser" last="Mandourah">Yasser Mandourah</name><affiliation><nlm:affiliation>Military Medical Services, Ministry of Defense, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Mekhlafi, Ghaleb A" sort="Al Mekhlafi, Ghaleb A" uniqKey="Al Mekhlafi G" first="Ghaleb A" last="Al Mekhlafi">Ghaleb A. Al Mekhlafi</name><affiliation><nlm:affiliation>Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Sherbeeni, Nisreen Murad" sort="Sherbeeni, Nisreen Murad" uniqKey="Sherbeeni N" first="Nisreen Murad" last="Sherbeeni">Nisreen Murad Sherbeeni</name><affiliation><nlm:affiliation>Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Elzein, Fatehi Elnour" sort="Elzein, Fatehi Elnour" uniqKey="Elzein F" first="Fatehi Elnour" last="Elzein">Fatehi Elnour Elzein</name><affiliation><nlm:affiliation>Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Almotairi, Abdullah" sort="Almotairi, Abdullah" uniqKey="Almotairi A" first="Abdullah" last="Almotairi">Abdullah Almotairi</name><affiliation><nlm:affiliation>Department of Critical Care Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Bshabshe, Ali" sort="Al Bshabshe, Ali" uniqKey="Al Bshabshe A" first="Ali" last="Al Bshabshe">Ali Al Bshabshe</name><affiliation><nlm:affiliation>Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Kharaba, Ayman" sort="Kharaba, Ayman" uniqKey="Kharaba A" first="Ayman" last="Kharaba">Ayman Kharaba</name><affiliation><nlm:affiliation>Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Jose, Jesna" sort="Jose, Jesna" uniqKey="Jose J" first="Jesna" last="Jose">Jesna Jose</name><affiliation><nlm:affiliation>Department Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Harthy, Abdulrahman" sort="Al Harthy, Abdulrahman" uniqKey="Al Harthy A" first="Abdulrahman" last="Al Harthy">Abdulrahman Al Harthy</name><affiliation><nlm:affiliation>Intensive Care Unit, King Saud Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Al Sulaiman, Mohammed" sort="Al Sulaiman, Mohammed" uniqKey="Al Sulaiman M" first="Mohammed" last="Al Sulaiman">Mohammed Al Sulaiman</name><affiliation><nlm:affiliation>Infectious Disease, King Saud Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Mady, Ahmed" sort="Mady, Ahmed" uniqKey="Mady A" first="Ahmed" last="Mady">Ahmed Mady</name><affiliation><nlm:affiliation>Intensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Fowler, Robert A" sort="Fowler, Robert A" uniqKey="Fowler R" first="Robert A" last="Fowler">Robert A. Fowler</name><affiliation><nlm:affiliation>Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Hayden, Frederick G" sort="Hayden, Frederick G" uniqKey="Hayden F" first="Frederick G" last="Hayden">Frederick G. Hayden</name><affiliation><nlm:affiliation>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, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name><affiliation><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Abdelzaher, Mohamed" sort="Abdelzaher, Mohamed" uniqKey="Abdelzaher M" first="Mohamed" last="Abdelzaher">Mohamed Abdelzaher</name><affiliation><nlm:affiliation>Critical Care Medicine Department, King Abdullah Medical Complex, Jeddah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Bajhmom, Wail" sort="Bajhmom, Wail" uniqKey="Bajhmom W" first="Wail" last="Bajhmom">Wail Bajhmom</name><affiliation><nlm:affiliation>Internal Medicine Department, King Fahad General Hospital, Ministry of Health, Jeddah, Saudi Arabia.</nlm:affiliation></affiliation></author><author><name sortKey="Hussein, Mohamed A" sort="Hussein, Mohamed A" uniqKey="Hussein M" first="Mohamed A" last="Hussein">Mohamed A. Hussein</name><affiliation><nlm:affiliation>Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">31900204</PMID><DateRevised><Year>2020</Year><Month>03</Month><Day>27</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>21</Volume><Issue>1</Issue><PubDate><Year>2020</Year><Month>Jan</Month><Day>03</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>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.</ArticleTitle><Pagination><MedlinePgn>8</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-019-3846-x</ELocationID><Abstract><AbstractText>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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Arabi</LastName><ForeName>Yaseen M</ForeName><Initials>YM</Initials><Identifier Source="ORCID">http://orcid.org/0000-0001-5735-6241</Identifier><AffiliationInfo><Affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. arabi@ngha.med.sa.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Intensive Care Department, Ministry of the National Guard - Health Affairs, ICU 1425, P.O. Box 22490, Riyadh, 11426, Saudi Arabia. arabi@ngha.med.sa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Asiri</LastName><ForeName>Ayed Y</ForeName><Initials>AY</Initials><AffiliationInfo><Affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Assiri</LastName><ForeName>Abdullah M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Infection Prevention and Control, Assistant Deputy Minister, Preventive Health, Ministry of Health, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aziz Jokhdar</LastName><ForeName>Hani A</ForeName><Initials>HA</Initials><AffiliationInfo><Affiliation>Deputy Minister for Public Health, Ministry of Health, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Alothman</LastName><ForeName>Adel</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Medicine, Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Balkhy</LastName><ForeName>Hanan H</ForeName><Initials>HH</Initials><AffiliationInfo><Affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Infection Prevention and Control, Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>AlJohani</LastName><ForeName>Sameera</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pathology and Laboratory Medicine, Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al Harbi</LastName><ForeName>Shmeylan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Pharmaceutical Care Department, Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kojan</LastName><ForeName>Suleiman</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Medicine, Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al Jeraisy</LastName><ForeName>Majed</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Pharmaceutical Care Department, Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Deeb</LastName><ForeName>Ahmad M</ForeName><Initials>AM</Initials><Identifier Source="ORCID">http://orcid.org/0000-0002-3680-7338</Identifier><AffiliationInfo><Affiliation>King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Research Office, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Memish</LastName><ForeName>Ziad A</ForeName><Initials>ZA</Initials><AffiliationInfo><Affiliation>Prince Mohammed bin Abdulaziz Hospital, Ministry of Health & College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ghazal</LastName><ForeName>Sameeh</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al Faraj</LastName><ForeName>Sarah</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al-Hameed</LastName><ForeName>Fahad</ForeName><Initials>F</Initials><Identifier Source="ORCID">http://orcid.org/0000-0003-0231-871X</Identifier><AffiliationInfo><Affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Intensive Care Department, Ministry of the National Guard - Health Affairs, Jeddah, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>AlSaedi</LastName><ForeName>Asim</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Infection Prevention and Control, Ministry of the National Guard - Health Affairs, Jeddah, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mandourah</LastName><ForeName>Yasser</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Military Medical Services, Ministry of Defense, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al Mekhlafi</LastName><ForeName>Ghaleb A</ForeName><Initials>GA</Initials><AffiliationInfo><Affiliation>Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sherbeeni</LastName><ForeName>Nisreen Murad</ForeName><Initials>NM</Initials><AffiliationInfo><Affiliation>Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Elzein</LastName><ForeName>Fatehi Elnour</ForeName><Initials>FE</Initials><AffiliationInfo><Affiliation>Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Almotairi</LastName><ForeName>Abdullah</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Critical Care Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al Bshabshe</LastName><ForeName>Ali</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kharaba</LastName><ForeName>Ayman</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jose</LastName><ForeName>Jesna</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al Harthy</LastName><ForeName>Abdulrahman</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Intensive Care Unit, King Saud Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al Sulaiman</LastName><ForeName>Mohammed</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Infectious Disease, King Saud Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mady</LastName><ForeName>Ahmed</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Intensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Anesthesiology and Intensive Care, Tanta University Hospitals, Tanta, Egypt.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fowler</LastName><ForeName>Robert A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Critical Care Medicine and Department of Medicine, Sunnybrook Hospital, Bayview Avenue, Room D478, Toronto, 2075, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hayden</LastName><ForeName>Frederick G</ForeName><Initials>FG</Initials><AffiliationInfo><Affiliation>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, Charlottesville, Virginia, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al-Dawood</LastName><ForeName>Abdulaziz</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Intensive Care Department, Ministry of the National Guard - Health Affairs, ICU 1425, P.O. Box 22490, Riyadh, 11426, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Abdelzaher</LastName><ForeName>Mohamed</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Critical Care Medicine Department, King Abdullah Medical Complex, Jeddah, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Critical Care Medicine Department, Cairo University Hospital, Cairo, Egypt.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bajhmom</LastName><ForeName>Wail</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Internal Medicine Department, King Fahad General Hospital, Ministry of Health, Jeddah, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hussein</LastName><ForeName>Mohamed A</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>and the Saudi Critical Care Trials group</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT02845843</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>RC15/142/R</GrantID><Agency>King Abdullah International Medical Research Center</Agency><Country></Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>01</Month><Day>03</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Antiviral</Keyword><Keyword MajorTopicYN="N">Clinical trial</Keyword><Keyword MajorTopicYN="N">Coronavirus</Keyword><Keyword MajorTopicYN="N">Interferon-β1b</Keyword><Keyword MajorTopicYN="N">Lopinavir/ritonavir</Keyword><Keyword MajorTopicYN="N">MERS</Keyword><Keyword MajorTopicYN="N">Protocol</Keyword><Keyword MajorTopicYN="N">Statistical analysis plan</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2018</Year><Month>12</Month><Day>09</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2019</Year><Month>10</Month><Day>24</Day></PubMedPubDate><PubMedPubDate 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