A clinical study of a new virus adsorption therapy in patients with severe COVID-19 infection

JRCT ID: jRCTs052200134

Registered date:15/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19 infection
• Date of first enrollment: 13/08/2021
• Target sample size: 25
• Study type: Interventional
• Intervention(s): blood adsorption therapy

Outcome(s)

• Primary Outcome: The ratio of the patients who were able to withdraw from the ventilator or ECMO

Secondary Outcome

The ratio of the patients who turned negative for virus in the blood
Improvement of respiratory function (PaO2/FiO2 ratio)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who show positive for nucleic acid of SARS-CoV-2 in the blood at the pre-enrollment test
2) Patients who need on artificial ventilator or ECMO
3) Patients who voluntarily give a written consent after receiving a thorough explanation and having an adequate understanding to be enrolled in the study
4) Patients whose age is 18 or elder when obtaining the consent . If the patient is under 20, the consent shuld be obtained from a legal representative such as a person in parental authority in addition to the patient itself.

Exclude criteria

1) Patients whose circulatory dynamics is unstable and difficult to put on the adsorption therapy
2) Patients who are participating other interventional clinical studies
3) Patients who are pregnant or possibly pregnant or lactating
4) Patients judged by the principal investigator or subinvestigator inappropriate to be enrolled in the study

Related Information

• Primary Sponsor: Isaka Yoshitaka
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development