ClinicalTrials.gov
ClinicalTrials.gov Menu

Anti-MERS-CoV Convalescent Plasma Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02190799
Recruitment Status : Withdrawn
First Posted : July 15, 2014
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
King Abdullah International Medical Research Center

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) Biological: Convalescent plasma Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: Death in the ICU at or after 90 days of enrollment ]
    Death in the ICU during the same hospital admission.

  2. 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.

  3. 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.

  4. 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

  5. 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)

  6. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
Saudi Arabia
Intensive Care Unit, King Abdulaziz Medical City
Riyadh,, Saudi Arabia, 11426
Sponsors and Collaborators
King Abdullah International Medical Research Center
Investigators
Principal Investigator: Yaseen M Arabi, MD King Abdullah International Medical Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT02190799     History of Changes
Other Study ID Numbers: RC13-244
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

Keywords provided by King Abdullah International Medical Research Center:
Corona Virus
Convalescent plasma
Serology

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases