Anti-MERS-CoV Convalescent Plasma Therapy

Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) Clinical Trial

Official title:

Anti-MERS-COV Convalescent Plasma Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02190799
• Other study ID #: RC13-244
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: November 2016

Study information

• Verified date: November 2018
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Respiratory Distress Syndrome (& [Hyaline Membrane Disease])
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Intensive Care Unit, King Abdulaziz Medical City	Riyadh,

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chest X ray	X ray changes at day 0, 1, 3, 7, 14, 21 and 28	Serial changes in the X ray till day 28
Primary	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	ICU mortality	Death in the ICU during the same hospital admission.	Death in the ICU at or after 90 days of enrollment
Secondary	ICU Length of Stay	Number of calendar days between admission and final discharge from ICU.	Number of days in ICU with an average expected duration of 10 days.
Secondary	Duration of Mechanical Ventilation	Number of calendar days between start and final liberation from mechanical ventilation.	Number of days of mechanical ventilation with an expected average duration of 8 days
Secondary	Viral load in tracheal aspirate	viral clearance from all sampled sites by day 3 after administration of CP	Serial levels in the first 28 days of enrollment
Secondary	Inflammatory markers,	Epidermal Growth Factor (EGF), Eotaxin, Granulocyte colony-stimulating factor (G-CSF), Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interferon(IFN)-?, IFN-a2, Interleukin (IL)-10, IL-12(p40), IL-12(p70), IL-13, IL-15, IL-17, IL-1ra, IL-1a, IL-1ß, 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-1ß, Tumor Necrosis Factor-a (TNF-a), TNF-ß, Vascular Endothelial Growth Factor (VEGF)	Serial levels in the first 28 days of enrollment
Secondary	Anti-MERS-CoV antibodies	anti-MERS-CoV antibody level before and after administration of CP.	Serial levels in the first 28 days of enrollment