Clinical trial NCT02190799: Anti-MERS-CoV Convalescent Plasma Therapy
Official title: Anti-MERS-COV Convalescent Plasma Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Respiratory Distress Syndrome (& [Hyaline Membrane Disease])
Keywords: Corona Virus
Convalescent plasma
Serology
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Hospital mortality
timeFrame: Death in the Hospital (ICU or ward) before or at 6 months after enrollment
Secondary outcomes:
measure: ICU mortality
timeFrame: Death in the ICU at or after 90 days of enrollment
measure: ICU Length of Stay
timeFrame: Number of days in ICU with an average expected duration of 10 days.
measure: Duration of Mechanical Ventilation
timeFrame: Number of days of mechanical ventilation with an expected average duration of 8 days
measure: Viral load in tracheal aspirate
timeFrame: Serial levels in the first 28 days of enrollment
measure: Inflammatory markers,
timeFrame: Serial levels in the first 28 days of enrollment
measure: Anti-MERS-CoV antibodies
timeFrame: Serial levels in the first 28 days of enrollment
Other outcomes:
measure: Chest X ray
timeFrame: Serial changes in the X ray till day 28
Locations:
city: Riyadh,
country: Saudi Arabia
facility: Intensive Care Unit, King Abdulaziz Medical City
Study officials:
affiliation: King Abdullah International Medical Research Center
name: Yaseen M Arabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arabi Y, Balkhy H, Hajeer AH, Bouchama A, Hayden FG, Al-Omari A, Al-Hameed FM, Taha Y, Shindo N, Whitehead J, Merson L, AlJohani S, Al-Khairy K, Carson G, Luke TC, Hensley L, Al-Dawood A, Al-Qahtani S, Modjarrad K, Sadat M, Rohde G, Leport C, Fowler R. Feasibility, safety, clinical, and laboratory effects of convalescent plasma therapy for patients with Middle East respiratory syndrome coronavirus infection: a study protocol. Springerplus. 2015 Nov 19;4:709. doi: 10.1186/s40064-015-1490-9. eCollection 2015.