Saudi Outcomes of ECMO-treated MERS-CoV Patients

NCT02627378 | Completed Phase 1 DMC

• 1 other identifier: A-00190
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

A highly pathogenic human coronavirus causing respiratory disease emerged in Saudi Arabia in 2012. This viral infection termed Middle East respiratory syndrome coronavirus (MERS-CoV) is associated with high mortality rate in approximately 36% of reported patients. The World Health Organization (WHO) reported 1,374 laboratory-confirmed worldwide infections, including at least 490 related deaths, from September, 2012, to July 24, 2015.2 The higher incidence of MERS-CoV infections in Saudi Arabia may be related to multiple factors, including seasonality, increased proactive screening, poor infection control measures, low relative humidity, and high temperature. Infected patients with MERS-CoV usually have abnormal findings on chest radiography, ranging from subtle to extensive unilateral and bilateral abnormalities. MERS progresses rapidly to respiratory failure, in approximately 2/3 of infected patients, which has a high mortality rate, particularly in immunocompromised patients. Extracorporeal membrane oxygenation (ECMO) has emerged as a rescue therapy in patients with refractory hypoxemia during the H1N1 epidemic.The use of veno-venous (VV)-ECMO provides respiratory support for patients with respiratory failure, whereas the use of veno-arterial (VA)-ECMO could be helpful in those with cardiorespiratory failure.10 However, the survival rate of the infected patients with H1N1 who required the use of ECMO varies considerably among the Caucasian and Asian countries (90% survival in Sweden and 83% in the UK13 vs. 35% in Japan). This large discrepancy could be explained with lack of satisfactory equipment, therapeutic guidelines, training of staff, and effective systems allowing patient transfer to the dedicated ECMO centres. Guery and co-investigators described the use of ECMO in two French patients with cardiorespiratory failure secondary to MERS-CoV infection.This has been extended for treatment of refractory hypoxemic respiratory failure during the Saudi MERS-CoV outbreak.

Conditions

MERS-CoV Infection; Refractory Hypoxemia

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  In-hospital mortality

  For 2 months after admission to hospital

Secondary Outcomes (20)

• Use of antiviral medications

  For 2 months after admission to hospital

• Use of steroid medications

  For 2 months after admission to hospital

• Use of interferons

  For 2 months after admission to hospital

• Use of immunoglobulin

  For 2 months after admission to hospital

• Use of vasopressor medications

  For 2 months after admission to hospital

Other Outcomes (11)

• Number of participants with diabetes milletus on blood glucose test

  For 1 month before admission to hospital

• Number of participants with pregnancy on pregnancy test

  For 9 months before admission to hospital

• Number of participants with hypertension on blood pressure recordings

  For 1 month before admission to hospital

Study Arms (2)

Extracorporeal Membrane Oxygenation

ACTIVE COMPARATOR

Patients received Extracorporeal Membrane Oxygenation (ECMO) support

Other: Extracorporeal Membrane Oxygenation

Non Extracorporeal Membrane Oxygenation

PLACEBO COMPARATOR

Patients did not receive Extracorporeal Membrane Oxygenation (ECMO) support

Other: Non Extracorporeal Membrane Oxygenation

Interventions

Extracorporeal Membrane Oxygenation OTHER

Patients received veno-venous Extracorporeal Membrane Oxygenation (ECMO) support

Extracorporeal Membrane Oxygenation

Non Extracorporeal Membrane Oxygenation OTHER

Patients received no Extracorporeal Membrane Oxygenation (ECMO) support

Non Extracorporeal Membrane Oxygenation

Eligibility Criteria

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

You may qualify if:

• Positive infection with Middle East Respiratory Syndrome virus
• Refractory hypoxemic respiratory failure
• Eligible for use of extracorporeal membrane oxygenation support (ECMO)

You may not qualify if:

• Neonates
• Children
• Patients treated with ECMO for primary cardiac failure
• Following heart transplantation
• Following lung transplantation
• Following cardiac surgery
• Patients with an alternative diagnosis who had no virus isolated

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead
• Ministry of Health, Saudi Arabia: collaborator
• King Abdulaziz University: collaborator

Study Sites (1)

Dammam University KFHU

Khobar, EP, 31952, Saudi Arabia

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Anees Sindi, FRCPC

  King Abdulaziz University, Jeddah, Saudi Arabia

  PRINCIPAL INVESTIGATOR

• Muhammed S Alshahrani, FRCPC

  University of Dammam, Dammam, Saudi Arabia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 10, 2015
• Study Start: September 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)