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 registrationClinicalTrials.gov, NCT02845843. Registered on 27 July 2016.

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Middle East respiratory syndrome coronavirus (MERS-CoV) shedding and antibody responses are not fully understood, particularly in relation to underlying medical conditions, clinical manifestations, and mortality. We enrolled MERS-CoV–positive patients at a hospital in Saudi Arabia and periodically collected specimens from multiple sites for real-time reverse transcription PCR and serologic testing. We conducted interviews and chart abstractions to collect clinical, epidemiologic, and laboratory information. We found that diabetes mellitus among survivors was associated with prolonged MERS-CoV RNA detection in the respiratory tract. Among case-patients who died, development of robust neutralizing serum antibody responses during the second and third week of illness was not sufficient for patient recovery or virus clearance. Fever and cough among mildly ill patients typically aligned with RNA detection in the upper respiratory tract; RNA levels peaked during the first week of illness. These findings should be considered in the development of infection control policies, vaccines, and antibody therapeutics.

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The Hajj pilgrimage, held in the Kingdom of Saudi Arabia, is among the largest mass gatherings in the world. More than 2.5 million Muslim pilgrims assemble from over 180 countries worldwide to perform Hajj. The Saudi government recognized the potential risks associated with this event since the first novel coronavirus disease 2019 (COVID-19) case was detected in the country on March 2, 2020. The return of possibly infected pilgrims to their countries after this huge mass gathering event could have turned Hajj into a superspreading event during the global COVID-19 pandemic. A multidisciplinary Saudi team from governmental sectors, including the Global Center for Mass Gatherings Medicine, shared in the assessment, planning, execution, and success of this holy event to prevent the spread of disease. The World Health Organization welcomed the Saudi government's decision to protect the wellbeing and safety of pilgrims and strengthen regional and global health security. A total of 1,000 pilgrims from 160 different countries were randomly selected to perform the rituals. Of all the pilgrims, healthcare personnel, and nonmedical employees facilitating the rituals, no confirmed cases of COVID-19 were identified during or after Hajj. This article highlights the success of the risk mitigation plan in place during the Hajj pilgrimage in 2020 (1441 Hijri year) during the COVID-19 pandemic and the efforts of the Saudi government to prevent associated outbreaks.