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/Curation ); 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 [Arabie saoudite] ; Ayed Y. Asiri [Arabie saoudite] ; Abdullah M. Assiri [Arabie saoudite] ; Hani A. Aziz Jokhdar [Arabie saoudite] ; Adel Alothman [Arabie saoudite] ; Hanan H. Balkhy [Arabie saoudite] ; Sameera Aljohani [Arabie saoudite] ; Shmeylan Al Harbi [Arabie saoudite] ; Suleiman Kojan [Arabie saoudite] ; Majed Al Jeraisy [Arabie saoudite] ; Ahmad M. Deeb [Arabie saoudite] ; Ziad A. Memish [Arabie saoudite] ; Sameeh Ghazal [Arabie saoudite] ; Sarah Al Faraj [Arabie saoudite] ; Fahad Al-Hameed [Arabie saoudite] ; Asim Alsaedi [Arabie saoudite] ; Yasser Mandourah [Arabie saoudite] ; Ghaleb A. Al Mekhlafi [Arabie saoudite] ; Nisreen Murad Sherbeeni [Arabie saoudite] ; Fatehi Elnour Elzein [Arabie saoudite] ; Abdullah Almotairi [Arabie saoudite] ; Ali Al Bshabshe [Arabie saoudite] ; Ayman Kharaba [Arabie saoudite] ; Jesna Jose [Arabie saoudite] ; Abdulrahman Al Harthy [Arabie saoudite] ; Mohammed Al Sulaiman [Arabie saoudite] ; Ahmed Mady [Arabie saoudite] ; Robert A. Fowler [Canada] ; Frederick G. Hayden [États-Unis] ; Abdulaziz Al-Dawood [Arabie saoudite] ; Mohamed Abdelzaher [Arabie saoudite] ; Wail Bajhmom [Arabie saoudite] ; Mohamed A. Hussein [Arabie saoudite]Source :
- 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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<author><name sortKey="Al Harbi, Shmeylan" sort="Al Harbi, Shmeylan" uniqKey="Al Harbi S" first="Shmeylan" last="Al Harbi">Shmeylan Al Harbi</name>
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<author><name sortKey="Kojan, Suleiman" sort="Kojan, Suleiman" uniqKey="Kojan S" first="Suleiman" last="Kojan">Suleiman Kojan</name>
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<author><name sortKey="Al Jeraisy, Majed" sort="Al Jeraisy, Majed" uniqKey="Al Jeraisy M" first="Majed" last="Al Jeraisy">Majed Al Jeraisy</name>
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<author><name sortKey="Deeb, Ahmad M" sort="Deeb, Ahmad M" uniqKey="Deeb A" first="Ahmad M" last="Deeb">Ahmad M. Deeb</name>
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<author><name sortKey="Sherbeeni, Nisreen Murad" sort="Sherbeeni, Nisreen Murad" uniqKey="Sherbeeni N" first="Nisreen Murad" last="Sherbeeni">Nisreen Murad Sherbeeni</name>
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<author><name sortKey="Kharaba, Ayman" sort="Kharaba, Ayman" uniqKey="Kharaba A" first="Ayman" last="Kharaba">Ayman Kharaba</name>
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<author><name sortKey="Jose, Jesna" sort="Jose, Jesna" uniqKey="Jose J" first="Jesna" last="Jose">Jesna Jose</name>
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<author><name sortKey="Al Harthy, Abdulrahman" sort="Al Harthy, Abdulrahman" uniqKey="Al Harthy A" first="Abdulrahman" last="Al Harthy">Abdulrahman Al Harthy</name>
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<author><name sortKey="Al Sulaiman, Mohammed" sort="Al Sulaiman, Mohammed" uniqKey="Al Sulaiman M" first="Mohammed" last="Al Sulaiman">Mohammed Al Sulaiman</name>
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<author><name sortKey="Mady, Ahmed" sort="Mady, Ahmed" uniqKey="Mady A" first="Ahmed" last="Mady">Ahmed Mady</name>
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<author><name sortKey="Fowler, Robert A" sort="Fowler, Robert A" uniqKey="Fowler R" first="Robert A" last="Fowler">Robert A. Fowler</name>
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<author><name sortKey="Hayden, Frederick G" sort="Hayden, Frederick G" uniqKey="Hayden F" first="Frederick G" last="Hayden">Frederick G. Hayden</name>
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<author><name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name>
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<author><name sortKey="Abdelzaher, Mohamed" sort="Abdelzaher, Mohamed" uniqKey="Abdelzaher M" first="Mohamed" last="Abdelzaher">Mohamed Abdelzaher</name>
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<author><name sortKey="Bajhmom, Wail" sort="Bajhmom, Wail" uniqKey="Bajhmom W" first="Wail" last="Bajhmom">Wail Bajhmom</name>
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<author><name sortKey="Hussein, Mohamed A" sort="Hussein, Mohamed A" uniqKey="Hussein M" first="Mohamed A" last="Hussein">Mohamed A. Hussein</name>
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<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>
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<author><name sortKey="Alothman, Adel" sort="Alothman, Adel" uniqKey="Alothman A" first="Adel" last="Alothman">Adel Alothman</name>
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<author><name sortKey="Balkhy, Hanan H" sort="Balkhy, Hanan H" uniqKey="Balkhy H" first="Hanan H" last="Balkhy">Hanan H. Balkhy</name>
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<author><name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name>
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<wicri:regionArea>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh</wicri:regionArea>
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<author><name sortKey="Al Harbi, Shmeylan" sort="Al Harbi, Shmeylan" uniqKey="Al Harbi S" first="Shmeylan" last="Al Harbi">Shmeylan Al Harbi</name>
<affiliation wicri:level="1"><nlm:affiliation>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh</wicri:regionArea>
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</author>
<author><name sortKey="Kojan, Suleiman" sort="Kojan, Suleiman" uniqKey="Kojan S" first="Suleiman" last="Kojan">Suleiman Kojan</name>
<affiliation wicri:level="1"><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Research Office, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Research Office, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Ministry of Health & College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Prince Mohammed bin Abdulaziz Hospital, Ministry of Health & College of Medicine, Alfaisal University, Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Ghazal, Sameeh" sort="Ghazal, Sameeh" uniqKey="Ghazal S" first="Sameeh" last="Ghazal">Sameeh Ghazal</name>
<affiliation wicri:level="1"><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Prince Mohammed bin Abdulaziz Hospital, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Prince Mohammed bin Abdulaziz Hospital, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Prince Mohammed bin Abdulaziz Hospital, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Alsaedi, Asim" sort="Alsaedi, Asim" uniqKey="Alsaedi A" first="Asim" last="Alsaedi">Asim Alsaedi</name>
<affiliation wicri:level="1"><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Mandourah, Yasser" sort="Mandourah, Yasser" uniqKey="Mandourah Y" first="Yasser" last="Mandourah">Yasser Mandourah</name>
<affiliation wicri:level="1"><nlm:affiliation>Military Medical Services, Ministry of Defense, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Military Medical Services, Ministry of Defense, Prince Sultan Military Medical City, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Infectious Diseases Division, Prince Sultan Military Medical City, Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Almotairi, Abdullah" sort="Almotairi, Abdullah" uniqKey="Almotairi A" first="Abdullah" last="Almotairi">Abdullah Almotairi</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Critical Care Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Department of Critical Care Medicine, King Fahad Medical City, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Kharaba, Ayman" sort="Kharaba, Ayman" uniqKey="Kharaba A" first="Ayman" last="Kharaba">Ayman Kharaba</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Jose, Jesna" sort="Jose, Jesna" uniqKey="Jose J" first="Jesna" last="Jose">Jesna Jose</name>
<affiliation wicri:level="1"><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>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Department Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Intensive Care Unit, King Saud Medical City, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Intensive Care Unit, King Saud Medical City, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Infectious Disease, King Saud Medical City, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Infectious Disease, King Saud Medical City, Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Mady, Ahmed" sort="Mady, Ahmed" uniqKey="Mady A" first="Ahmed" last="Mady">Ahmed Mady</name>
<affiliation wicri:level="1"><nlm:affiliation>Intensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Intensive Care Department, King Saud Medical City, Riyadh</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Institute of Health Policy Management and Evaluation, University of Toronto, Toronto</wicri:regionArea>
</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 wicri:level="1"><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>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>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</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Abdelzaher, Mohamed" sort="Abdelzaher, Mohamed" uniqKey="Abdelzaher M" first="Mohamed" last="Abdelzaher">Mohamed Abdelzaher</name>
<affiliation wicri:level="1"><nlm:affiliation>Critical Care Medicine Department, King Abdullah Medical Complex, Jeddah, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Critical Care Medicine Department, King Abdullah Medical Complex, Jeddah</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Bajhmom, Wail" sort="Bajhmom, Wail" uniqKey="Bajhmom W" first="Wail" last="Bajhmom">Wail Bajhmom</name>
<affiliation wicri:level="1"><nlm:affiliation>Internal Medicine Department, King Fahad General Hospital, Ministry of Health, Jeddah, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Internal Medicine Department, King Fahad General Hospital, Ministry of Health, Jeddah</wicri:regionArea>
</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 wicri:level="1"><nlm:affiliation>Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</nlm:affiliation>
<country xml:lang="fr">Arabie saoudite</country>
<wicri:regionArea>Ministry of the National Guard - Health Affairs, Riyadh</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series><title level="j">Trials</title>
<idno type="eISSN">1745-6215</idno>
<imprint><date when="2020" type="published">2020</date>
</imprint>
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<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>
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<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>
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<Initials>A</Initials>
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<Initials>MA</Initials>
<AffiliationInfo><Affiliation>Ministry of the National Guard - Health Affairs, Riyadh, Saudi Arabia.</Affiliation>
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<Country></Country>
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