Anti-MERS-CoV Convalescent Plasma Therapy

• ClinicalTrials.gov Identifier: NCT02190799
• Recruitment Status: Withdrawn
• First Posted: July 15, 2014
• Last Update Posted: November 21, 2018
• Sponsor: King Abdullah International Medical Research Center
• Information provided by (Responsible Party): King Abdullah International Medical Research Center

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: King Abdullah International Medical Research Center
• ClinicalTrials.gov Identifier: NCT02190799
• Other Study ID Numbers: RC13-244
• First Posted: July 15, 2014
• 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; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases