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

被引：93

作者：

Arabi, Yaseen M. ^{[1
,2
]}

Asiri, Ayed Y. ^{[3
]}

Assiri, Abdullah M. ^{[4
]}

Aziz Jokhdar, Hani A. ^{[5
]}

Alothman, Adel ^{[1
,6
]}

Balkhy, Hanan H. ^{[1
,7
]}

AlJohani, Sameera ^{[1
,8
]}

Al Harbi, Shmeylan ^{[9
,10
]}

Kojan, Suleiman ^{[1
,6
]}

Al Jeraisy, Majed ^{[9
,10
]}

Deeb, Ahmad M. ^{[11
,12
]}

Memish, Ziad A. ^{[13
,14
,15
]}

Ghazal, Sameeh ^{[3
]}

Al Faraj, Sarah ^{[3
]}

Al-Hameed, Fahad ^{[16
,17
]}

AlSaedi, Asim ^{[16
,18
]}

Mandourah, Yasser ^{[19
]}

Al Mekhlafi, Ghaleb A. ^{[20
]}

Sherbeeni, Nisreen Murad ^{[21
]}

Elzein, Fatehi Elnour ^{[21
]}

Almotairi, Abdullah ^{[22
]}

Al Bshabshe, Ali ^{[23
]}

Kharaba, Ayman ^{[24
]}

Jose, Jesna ^{[25
]}

Al Harthy, Abdulrahman ^{[26
]}

Al Sulaiman, Mohammed ^{[27
]}

Mady, Ahmed ^{[28
,29
]}

Fowler, Robert A. ^{[30
,31
,32
]}

Hayden, Frederick G. ^{[33
]}

Al-Dawood, Abdulaziz ^{[1
,2
]}

Abdelzaher, Mohamed ^{[34
,35
]}

Bajhmom, Wail ^{[36
]}

Hussein, Mohamed A. ^{[12
,25
]}

机构：

[1] King Saud Bin Abdulaziz Univ Hlth Sci, Coll Med, King Abdullah Int Med Res Ctr, Riyadh, Saudi Arabia

[2] Minist Natl Guard Hlth Affairs, Intens Care Dept, ICU 1425,POB 22490, Riyadh 11426, Saudi Arabia

[3] Prince Mohammed bin Abdulaziz Hosp, Riyadh, Saudi Arabia

[4] Minist Hlth, Infect Prevent & Control, Prevent Hlth, Riyadh, Saudi Arabia

[5] Minist Hlth, Publ Hlth, Riyadh, Saudi Arabia

[6] Minist Natl Guard Hlth Affairs, Dept Med, Riyadh, Saudi Arabia

[7] Minist Natl Guard Hlth Affairs, Dept Infect Prevent & Control, Riyadh, Saudi Arabia

[8] Minist Natl Guard Hlth Affairs, Dept Pathol & Lab Med, Riyadh, Saudi Arabia

[9] King Saud Bin Abdulaziz Univ Hlth Sci, Coll Pharm, King Abdullah Int Med Res Ctr, Riyadh, Saudi Arabia

[10] Minist Natl Guard Hlth Affairs, Pharmaceut Care Dept, Riyadh, Saudi Arabia

[11] King Saud Bin Abdulaziz Univ Hlth Sci, King Abdullah Int Med Res Ctr, Res Off, Riyadh, Saudi Arabia

[12] Minist Natl Guard Hlth Affairs, Riyadh, Saudi Arabia

[13] Alfaisal Univ, Prince Mohammed bin Abdulaziz Hosp, Minist Hlth, Riyadh, Saudi Arabia

[14] Alfaisal Univ, Coll Med, Riyadh, Saudi Arabia

[15] Emory Univ, Rollins Sch Publ Hlth, Hubert Dept Global Hlth, Atlanta, GA 30322 USA

[16] King Saud Bin Abdulaziz Univ Hlth Sci, Coll Med, King Abdullah Int Med Res Ctr, Jeddah, Saudi Arabia

[17] Minist Natl Guard Hlth Affairs, Intens Care Dept, Jeddah, Saudi Arabia

[18] Minist Natl Guard Hlth Affairs, Dept Infect Prevent & Control, Jeddah, Saudi Arabia

[19] Prince Sultan Mil Med City, Minist Def, Mil Med Serv, Riyadh, Saudi Arabia

[20] Prince Sultan Mil Med City, Dept Intens Care Serv, Riyadh, Saudi Arabia

[21] Prince Sultan Mil Med City, Infect Dis Div, Riyadh, Saudi Arabia

[22] King Fahad Med City, Dept Crit Care Med, Riyadh, Saudi Arabia

[23] King Khalid Univ, Aseer Cent Hosp, Dept Crit Care Med, Abha, Saudi Arabia

[24] King Fahad Hosp, Ohoud Hosp, Dept Crit Care, Al Madinah Al Monawarah, Saudi Arabia

[25] King Saud Bin Abdulaziz Univ Hlth Sci, King Abdullah Int Med Res Ctr, Dept Biostat & Bioinformat, Riyadh, Saudi Arabia

[26] King Saud Med City, Intens Care Unit, Riyadh, Saudi Arabia

[27] King Saud Med City, Infect Dis, Riyadh, Saudi Arabia

[28] King Saud Med City, Intens Care Dept, Riyadh, Saudi Arabia

[29] Tanta Univ Hosp, Dept Anesthesiol & Intens Care, Tanta, Egypt

[30] Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada

[31] Sunnybrook Med Ctr, Dept Crit Care Med, Bayview Ave,Room D478, Toronto, ON, Canada

[32] Sunnybrook Med Ctr, Dept Med, 2075 Bayview Ave,Room D478, Toronto, ON, Canada

[33] Univ Virginia, Sch Med, Int Severe Acute Resp & Emerging Infect Consortiu, Div Infect Dis & Int Hlth,Dept Med, Charlottesville, VA 22908 USA

[34] King Abdullah Med Complex, Crit Care Med Dept, Jeddah, Saudi Arabia

[35] Cairo Univ Hosp, Crit Care Med Dept, Cairo, Egypt

[36] Minist Hlth, King Fahad Gen Hosp, Internal Med Dept, Jeddah, Saudi Arabia

来源：

TRIALS | 2020年 / 21卷 / 01期

关键词：

Coronavirus; MERS; Antiviral; Clinical trial; Lopinavir; ritonavir; Interferon-beta; 1b; Statistical analysis plan; Protocol; INTERIM ANALYSES;

D O I：

10.1186/s13063-019-3846-x

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-beta 1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-beta 1b 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.

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