Cargando…
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
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 sta...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BioMed Central
2020
|
| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6942374/ https://www.ncbi.nlm.nih.gov/pubmed/31900204 http://dx.doi.org/10.1186/s13063-019-3846-x |
| _version_ | 1783484692487471104 |
|---|---|
| author | Arabi, Yaseen M. Asiri, Ayed Y. Assiri, Abdullah M. Aziz Jokhdar, Hani A. Alothman, Adel Balkhy, Hanan H. AlJohani, Sameera Al Harbi, Shmeylan Kojan, Suleiman Al Jeraisy, Majed Deeb, Ahmad M. Memish, Ziad A. Ghazal, Sameeh Al Faraj, Sarah Al-Hameed, Fahad AlSaedi, Asim Mandourah, Yasser Al Mekhlafi, Ghaleb A. Sherbeeni, Nisreen Murad Elzein, Fatehi Elnour Almotairi, Abdullah Al Bshabshe, Ali Kharaba, Ayman Jose, Jesna Al Harthy, Abdulrahman Al Sulaiman, Mohammed Mady, Ahmed Fowler, Robert A. Hayden, Frederick G. Al-Dawood, Abdulaziz Abdelzaher, Mohamed Bajhmom, Wail Hussein, Mohamed A. |
| author_facet | Arabi, Yaseen M. Asiri, Ayed Y. Assiri, Abdullah M. Aziz Jokhdar, Hani A. Alothman, Adel Balkhy, Hanan H. AlJohani, Sameera Al Harbi, Shmeylan Kojan, Suleiman Al Jeraisy, Majed Deeb, Ahmad M. Memish, Ziad A. Ghazal, Sameeh Al Faraj, Sarah Al-Hameed, Fahad AlSaedi, Asim Mandourah, Yasser Al Mekhlafi, Ghaleb A. Sherbeeni, Nisreen Murad Elzein, Fatehi Elnour Almotairi, Abdullah Al Bshabshe, Ali Kharaba, Ayman Jose, Jesna Al Harthy, Abdulrahman Al Sulaiman, Mohammed Mady, Ahmed Fowler, Robert A. Hayden, Frederick G. Al-Dawood, Abdulaziz Abdelzaher, Mohamed Bajhmom, Wail Hussein, Mohamed A. |
| author_sort | Arabi, Yaseen M. |
| collection | PubMed |
| description | 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. |
| format | Online Article Text |
| id | pubmed-6942374 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2020 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-69423742020-01-07 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 Arabi, Yaseen M. Asiri, Ayed Y. Assiri, Abdullah M. Aziz Jokhdar, Hani A. Alothman, Adel Balkhy, Hanan H. AlJohani, Sameera Al Harbi, Shmeylan Kojan, Suleiman Al Jeraisy, Majed Deeb, Ahmad M. Memish, Ziad A. Ghazal, Sameeh Al Faraj, Sarah Al-Hameed, Fahad AlSaedi, Asim Mandourah, Yasser Al Mekhlafi, Ghaleb A. Sherbeeni, Nisreen Murad Elzein, Fatehi Elnour Almotairi, Abdullah Al Bshabshe, Ali Kharaba, Ayman Jose, Jesna Al Harthy, Abdulrahman Al Sulaiman, Mohammed Mady, Ahmed Fowler, Robert A. Hayden, Frederick G. Al-Dawood, Abdulaziz Abdelzaher, Mohamed Bajhmom, Wail Hussein, Mohamed A. Trials Update 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. BioMed Central 2020-01-03 /pmc/articles/PMC6942374/ /pubmed/31900204 http://dx.doi.org/10.1186/s13063-019-3846-x Text en © The Author(s). 2020 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
| spellingShingle | Update Arabi, Yaseen M. Asiri, Ayed Y. Assiri, Abdullah M. Aziz Jokhdar, Hani A. Alothman, Adel Balkhy, Hanan H. AlJohani, Sameera Al Harbi, Shmeylan Kojan, Suleiman Al Jeraisy, Majed Deeb, Ahmad M. Memish, Ziad A. Ghazal, Sameeh Al Faraj, Sarah Al-Hameed, Fahad AlSaedi, Asim Mandourah, Yasser Al Mekhlafi, Ghaleb A. Sherbeeni, Nisreen Murad Elzein, Fatehi Elnour Almotairi, Abdullah Al Bshabshe, Ali Kharaba, Ayman Jose, Jesna Al Harthy, Abdulrahman Al Sulaiman, Mohammed Mady, Ahmed Fowler, Robert A. Hayden, Frederick G. Al-Dawood, Abdulaziz Abdelzaher, Mohamed Bajhmom, Wail Hussein, Mohamed A. 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 | 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_full | 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_fullStr | 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_full_unstemmed | 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_short | 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_sort | 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 |
| topic | Update |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6942374/ https://www.ncbi.nlm.nih.gov/pubmed/31900204 http://dx.doi.org/10.1186/s13063-019-3846-x |
| work_keys_str_mv | AT arabiyaseenm treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT asiriayedy treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT assiriabdullahm treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT azizjokhdarhania treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT alothmanadel treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT balkhyhananh treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT aljohanisameera treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT alharbishmeylan treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT kojansuleiman treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT aljeraisymajed treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT deebahmadm treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT memishziada treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT ghazalsameeh treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT alfarajsarah treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT alhameedfahad treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT alsaediasim treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT mandourahyasser treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT almekhlafighaleba treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT sherbeeninisreenmurad treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT elzeinfatehielnour treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT almotairiabdullah treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT albshabsheali treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT kharabaayman treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT josejesna treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT alharthyabdulrahman treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT alsulaimanmohammed treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT madyahmed treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT fowlerroberta treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT haydenfrederickg treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT aldawoodabdulaziz treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT abdelzahermohamed treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT bajhmomwail treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT husseinmohameda treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial AT treatmentofmiddleeastrespiratorysyndromewithacombinationoflopinavirritonavirandinterferonb1bmiracletrialstatisticalanalysisplanforarecursivetwostagegroupsequentialrandomizedcontrolledtrial |