Specified clinical trial for ECMO system for COVID-19 resipiratory failure

JRCT ID: jRCTs052200053

Registered date:07/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Severe respiratory failure due to COVID-19
• Date of first enrollment: 26/11/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): The highly efficient novel extracorporeal membrane oxygenation (ECMO) system will be used for patients with severe respiratory failure due to Coronavirus disease 2019 (COVID-19) refractory to to optimal medical management, standard surgical procedure, oxygen therapy, physical therapy and mechanical ventilator other than ECMO

Outcome(s)

• Primary Outcome: Exchange or withdrawal of trial device associated with device malfunction which affects patient's safety during trial device support (including withdrawal of trial device after patient death due to malfunction related adverse event)

Secondary Outcome

1) Total support period of a trial device
2) Removal of mechanical ventilation during device support and interval between implantation of a trial device and withdrawal of mechanical ventilation
3) All death during device support
4) Device-related death between implantation and 7days after withdrawal of a trial device
5) Adverse events and device failure
6) Changes in partial pressure of oxygen in the arterial blood (PaO2)
7) Changes in partial pressure of carbon dioxide in the arterial blood (PaCO2)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Severe respiratory failure due to COVID-19 including suspected cases
2) Severe respiratory failure refractory to optimal medical management, standard surgical procedure, oxygen therapy, physical therapy and mechanical ventilator other than ECMO
3) Aged 16 and over
4) Written informed consent of the patient or his/her relatives

Exclude criteria

1) Unfavorable or technically challenging cardiac and/or vascular anatomy
2) Irreversible chronic organ failure (heart, lung, liver and kidney etc.) (except when the primary investigator deems it as a sign of acute heart failure)
3) End stage malignancy
4) Contraindicated for anticoagulation
5) Participating or planning to participate in another clinical trial at time of study entry (except diagnostic device)
6) Deemed unsuitable by the primary investigator for other reasons

Related Information

• Primary Sponsor: Fukushima Norihide
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED)