Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial
Posted on 2018-01-30 - 05:00
Abstract Background It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. Methods The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. Discussion This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. Trial registration ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.
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Arabi, Yaseen; Alothman, Adel; Balkhy, Hanan; Al-Dawood, Abdulaziz; AlJohani, Sameera; Al Harbi, Shmeylan; et al. (2018). Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial. figshare. Collection. https://doi.org/10.6084/m9.figshare.c.3991491.v1
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AUTHORS (28)
YA
Yaseen Arabi
AA
Adel Alothman
HB
Hanan Balkhy
AA
Abdulaziz Al-Dawood
SA
Sameera AlJohani
SA
Shmeylan Al Harbi
SK
Suleiman Kojan
MA
Majed Al Jeraisy
AD
Ahmad Deeb
AA
Abdullah Assiri
FA
Fahad Al-Hameed
AA
Asim AlSaedi
YM
Yasser Mandourah
GA
Ghaleb Almekhlafi
NS
Nisreen Sherbeeni
FE
Fatehi Elzein
JM
Javed Memon
YT
Yusri Taha
AA
Abdullah Almotairi
KM
Khalid Maghrabi