Overview

This trial is active, not recruiting.

Condition respiratory distress syndrome (& [hyaline membrane disease])
Treatment convalescent plasma
Phase phase 2
Sponsor King Abdullah International Medical Research Center
Start date May 2014
End date May 2017
Trial size 20 participants
Trial identifier NCT02190799, RC13-244

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Enrolled patients will receive 2 units of the convalescent plasma after meeting the eligibility criteria
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 Outcomes

Measure
Hospital mortality
time frame: Death in the Hospital (ICU or ward) before or at 6 months after enrollment

Secondary Outcomes

Measure
ICU mortality
time frame: Death in the ICU at or after 90 days of enrollment
ICU Length of Stay
time frame: Number of days in ICU with an average expected duration of 10 days.
Duration of Mechanical Ventilation
time frame: Number of days of mechanical ventillation with an expected average duration of 8 days
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
Anti-MERS-CoV antibodies
time frame: Serial levels in the first 28 days of enrollment

Eligibility Criteria

Male or female participants at least 14 years old.

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.

Additional Information

Official title Anti-MERS-COV Convalescent Plasma Therapy
Principal investigator Yaseen M Arabi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by King Abdullah International Medical Research Center.