Anti-MERS-CoV Convalescent Plasma Therapy

NCT02190799 | Withdrawn Phase 2 DMC

• 1 other identifier: RC13-244
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome (& [Hyaline Membrane Disease])

Keywords

Corona Virus; Convalescent plasma; Serology

Outcome Measures

Primary Outcomes (1)

• Hospital mortality

  Hospital mortality will be death in the ICU during the same hospital admission

  Death in the Hospital (ICU or ward) before or at 6 months after enrollment

Secondary Outcomes (6)

• ICU mortality

  Death in the ICU at or after 90 days of enrollment

• ICU Length of Stay

  Number of days in ICU with an average expected duration of 10 days.

• Duration of Mechanical Ventilation

  Number of days of mechanical ventilation with an expected average duration of 8 days

• Viral load in tracheal aspirate

  Serial levels in the first 28 days of enrollment

• Inflammatory markers,

  Serial levels in the first 28 days of enrollment

Other Outcomes (1)

• Chest X ray

  Serial changes in the X ray till day 28

Study Arms (1)

Convalescent plasma

EXPERIMENTAL

Enrolled patients will receive 2 units of the convalescent plasma after meeting the eligibility criteria

Biological: Convalescent plasma

Interventions

Convalescent plasma BIOLOGICAL

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

Convalescent plasma

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Sites (1)

Intensive Care Unit, King Abdulaziz Medical City

Riyadh, 11426, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 26618098 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hyaline Membrane Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Distress Syndrome, Newborn; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yaseen M Arabi, MD

  King Abdullah International Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: July 15, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

SA (1)