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

Single-arm study for assessment of safety and usefulness of the highly efficient novel extracorporeal membrane oxygenation (ECMO) system use as respiratory failure due to Coronavirus disease 2019 (COVID-19): Study protocol for multiple-center, single-arm specified clinical trial. - COVID-19_ECMO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052200053

Enrollment

Registered

2020-09-07

Start date

2020-11-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe respiratory failure due to COVID-19 COVID-19, severe respiratory failure

Interventions

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 optim

ECMO, high durability

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Contacts

Public ContactNorihide Fukushima

National Cerebral and Cardiovascular Center

nori@ncvc.go.jp+81-6-6171-1070

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026