Anti-MERS-CoV Convalescent Plasma Therapy
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|ClinicalTrials.gov Identifier: NCT02190799|
Recruitment Status : Withdrawn
First Posted : July 15, 2014
Last Update Posted : November 21, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Respiratory Distress Syndrome (& [Hyaline Membrane Disease])||Biological: Convalescent plasma||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anti-MERS-COV Convalescent Plasma Therapy|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Convalescent plasma
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 [ 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
- 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 ventilation 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 ]viral clearance from all sampled sites by day 3 after administration of CP
- 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 ]anti-MERS-CoV antibody level before and after administration of CP.
- Chest X ray [ Time Frame: Serial changes in the X ray till day 28 ]X ray changes at day 0, 1, 3, 7, 14, 21 and 28
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|Ages Eligible for Study:||14 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age greater than or equal to 14 years of age
- Inpatients who are MERS-COV positive (by PCR)
- Willingness to have blood, respiratory and urine samples obtained and stored for subsequent analysis.
- Clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily not MERS-CoV in origin.
- History of allergic reaction to blood or plasma products (as judged by the investigator)
- Known IgA deficiency
- Medical conditions in which receipt of 500mL volume may be detrimental to the patient (e.g., decompensated congestive heart failure)
- Females who are pregnant or breast feeding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190799
|Intensive Care Unit, King Abdulaziz Medical City|
|Riyadh,, Saudi Arabia, 11426|
|Principal Investigator:||Yaseen M Arabi, MD||King Abdullah International Medical Research Center|
|Responsible Party:||King Abdullah International Medical Research Center|
|Other Study ID Numbers:||
|First Posted:||July 15, 2014 Key Record Dates|
|Last Update Posted:||November 21, 2018|
|Last Verified:||November 2018|
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Hyaline Membrane Disease
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases