Clinical Trial: Anti-MERS-COV Convalescent Plasma Therapy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Anti-MERS-COV Convalescent Plasma Therapy

Brief Summary: Since the first report of the Middle East Respiratory Syndrome Corona virus (MERS- CoV) in September 2012, more than 800 cases have been reported to the World Health Organization (WHO) with substantial mortality.

Detailed Summary: World knowledge about this virus is accumulating but data about the clinical presentations of infected patients and common treatments, including ribavirin, interferon and methylprednisolone, lack evidence. Although drugs with anti- coronavirus (CoV) activities have been identified, as yet no anti- MERs- CoV drug has been approved and a vaccine has yet to be developed. Previous reports on other viral infections including SARS have suggested that convalescent plasma or serum is effective where no other treatment is available or in an emergency. A recently completed systematic review and meta-analysis by the University of Nottingham - World Health Organization Collaborating Center indicates that convalescent plasma therapy may be the most promising near-term therapy patients with for MERS- CoV infection. In this study, investigators will study the pharmacokinetics of immunoglobulin in response to convalescent plasma administration in order to inform a much larger study which will investigate the efficacy of convalescent plasma. Plasma will be collected from patients who recently recovered from MERS-CoV, Health Care Workers who had potential exposure and are tested for anti MERS-CoV serology and RT-PCR after obtaining their consent. This convalescent plasma will be stored in the blood bank as per their policies and procedures. Patients with MERS-CoV positive after meeting the eligibility criteria will receive 2 units of convalescent plasma . Clinical data as well as the standard laboratory studies will be collected at baseline, 30 mins after first dose, 30 mins after second dose, day 1, 3, 7, 14, 28 of hospital stay after enrollment.
Sponsor: King Abdullah International Medical Research Center

Current Primary Outcome: Hospital mortality [ Time Frame: Death in the Hospital (ICU or ward) before or at 6 months after enrollment ]

Hospital mortality will be death in the ICU during the same hospital admission


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ICU mortality [ Time Frame: Death in the ICU at or after 90 days of enrollment ]
    Death in the ICU during the same hospital admission.
  • ICU Length of Stay [ Time Frame: Number of days in ICU with an average expected duration of 10 days. ]
    Number of calendar days between admission and final discharge from ICU.
  • Duration of Mechanical Ventilation [ Time Frame: Number of days of mechanical ventillation with an expected average duration of 8 days ]
    Number of calendar days between start and final liberation from mechanical ventilation.
  • Viral load in tracheal aspirate [ Time Frame: Serial levels in the first 28 days of enrollment ]
  • Inflammatory markers, [ Time Frame: Serial levels in the first 28 days of enrollment ]
    Epidermal Growth Factor (EGF), Eotaxin, Granulocyte colony-stimulating factor (G-CSF), Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interferon(IFN)-γ, IFN-a2, Interleukin (IL)-10, IL-12(p40), IL-12(p70), IL-13, IL-15, IL-17, IL-1ra, IL-1a, IL-1β, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, Interferon gamma-induced protein (IP)-10, Monocyte Chemotactic Protein (MCP)-1, Macrophage Inflammatory Protein (MIP)-1a, MIP-1β, Tumor Necrosis Factor-α (TNF-a), TNF-β, Vascular Endothelial Growth Factor (VEGF)
  • Anti-MERS-CoV antibodies [ Time Frame: Serial levels in the first 28 days of enrollment ]


Original Secondary Outcome: Same as current

Information By: King Abdullah International Medical Research Center

Dates:
Date Received: June 12, 2014
Date Started: May 2014
Date Completion: June 2017
Last Updated: August 30, 2016
Last Verified: August 2016