A Phase 2 interventional study of Convalescent plasma in Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), sponsored by King Abdullah International Medical Research Center. Withdrawn at 1 site in Saudi Arabia. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2018-11-21.
Sponsored by King Abdullah International Medical Research Center · Phase 2, Interventional, and Treatment
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.
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
Browse Respiratory Distress Syndrome studies →King Abdullah International Medical Research Center is the lead sponsor of 44 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enrolled patients will receive 2 units of the convalescent plasma after meeting the eligibility criteria
Biological: Convalescent plasma
Convalescent plasma from patients who recently recovered from MERS-CoV, HCWs who had potential exposure and subjects who are willing to donate plasma and have their blood tested for anti MERS-CoV serology and RT-PCR after obtaining their consent
Hospital mortality
Hospital mortality will be death in the ICU during the same hospital admission
Time frame: Death in the Hospital (ICU or ward) before or at 6 months after enrollment
ICU mortality
Death in the ICU during the same hospital admission.
Time frame: Death in the ICU at or after 90 days of enrollment
ICU Length of Stay
Number of calendar days between admission and final discharge from ICU.
Time frame: Number of days in ICU with an average expected duration of 10 days.
Duration of Mechanical Ventilation
Number of calendar days between start and final liberation from mechanical ventilation.
Time frame: Number of days of mechanical ventilation with an expected average duration of 8 days
Viral load in tracheal aspirate
viral clearance from all sampled sites by day 3 after administration of CP
Time frame: Serial levels in the first 28 days of enrollment
Inflammatory markers,
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)
Time frame: Serial levels in the first 28 days of enrollment
Anti-MERS-CoV antibodies
anti-MERS-CoV antibody level before and after administration of CP.
Time frame: Serial levels in the first 28 days of enrollment
Chest X ray
X ray changes at day 0, 1, 3, 7, 14, 21 and 28
Time frame: Serial changes in the X ray till day 28
This study is withdrawn, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
King Abdullah International Medical Research Center