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oXiris Membrane in Treating Critically Ill Hospitalized Adult Patients with novel coronavirus pneumonia (COVID-19)

The Effect and Safety of oXiris Membrane Treating Critically Ill Hospitalized Adult Patients with novel coronavirus pneumonia (COVID-19): a Single Center Prospective Open-label Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030477
Enrollment
Unknown
Registered
2020-03-03
Start date
2020-03-04
Completion date
Unknown
Last updated
2020-03-09

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

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Case series:oXiris membrane

Sponsors

Department of Nephrology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Written informed consent from patients or representative; 2. Aged over 18 years; 3. Fullfill the diagnostic criteria of critically ill 2019-nCoV Respiratory Disease; 2019-nCoV diagnosis confirmed by the combination of epidemiology, clinical manifestation and virus PCR results of respiratory specimen; Critically ill patients should include one of the followings at least: 1) respritary failure, mechanical ventilation required; 2) shock; 3) complicated with other organ failures, require ICU admission.

Exclusion criteria

Exclusion criteria: 1. Respiratory failure explained with other lung conditions, including influenza virus, bacterial infection, fungi infection, non-infectious causes; 2. Comorbidities including lupus, vasculitis, APS et al. 3. Concurrent use of anti-IL6 receptor antibody; 4. Malignancy; 5. Pregnancy; 6. Potential tranfer to other hospital during the trial; 7. Other potential conditions determined by the investigators.

Design outcomes

Primary

MeasureTime frame
28 day mortality;

Secondary

MeasureTime frame
Clinical improvement scores at Day 28;Mechanical ventilation time;vasopressor time;Duration of fever;Duration of ICU care;Cytokine measurement (TNF-alpha, IL-6, IL-10);Adverse effect;

Countries

China

Contacts

Public ContactXuemei Li

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

lixmpumch@126.com+86 13911467356

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026