Clinical Trial: MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b: a Multicenter, Placebo-controlled, Double-blind Randomized Trial
Brief Summary: This is a placebo-controlled clinical trial to assess the feasibility, efficacy and safety of a combination of lopinavir/ritonavir and Interferon beta-1b in hospitalized patients with MERS.
Detailed Summary: The aim of this study is to investigate the feasibility , efficacy and safety of lopinavir /ritonavir and recombinant Interferon beta-1b combination given with optimal supportive care compared to placebo with optimal supportive care for patients with laboratory-confirmed MERS-CoV infection requiring hospital admission.
Sponsor: King Abdullah International Medical Research Center
Current Primary Outcome: 90-day mortality [ Time Frame: 90-day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Organ support-free days (e.g., supplemental O2, ventilator, extracorporeal membrane oxygenation (ECMO), renal replacement and vasopressors) [ Time Frame: 28 days ]
- RT-PCR cycle threshold value in the lower respiratory samples [ Time Frame: At randomization and every 3 days afterwards, until 3 consecutive samples are negative or reaching a maximum of 90 days ]
- Sequential organ failure assessment (SOFA) scores [ Time Frame: Days 1, 3, 5, 7, 14, and 28 ]
- Length of stay in ICU [ Time Frame: Up to one year from enrollment ]
- Length of stay in hospital [ Time Frame: Up to one year from enrollment ]
- Duration of mechanical ventilation [ Time Frame: Up to one year from enrollment ]
- Hospital-acquired infections as assessed by the NHSN 2016 definitions [ Time Frame: Up to one year from enrollment ]Infections will be reported as per the NHSN 2016 definitions, as number of events per devise day or ICU day as appropriate.
- Serial chest radiograph findings [ Time Frame: 28 day ]
- Number of Patients with Adverse drug reactions related to the treatment [ Time Frame: From enrollment to 28 day ]
- Karnofsky Performance Scale [ Time Frame: 90-day ]
- ICU mortality [ Time Frame: Up to one year from enrollment ]
- Hospital mortality [ Time Frame: Up to one year from enrollment ]
- 28-day mortality [ Time Frame: 28-day ]
Original Secondary Outcome: Same as current
Information By: King Abdullah International Medical Research Center
Dates:
Date Received: June 20, 2016
Date Started: July 2016
Date Completion: July 2018
Last Updated: November 28, 2016
Last Verified: November 2016