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