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A clinical study of new aerosol inhalation in the treatment of severe patients with respiratory virus infection

A clinical study on the treatment of severe COVID-19 patients with a new aerosol inhalation agent

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040847
Enrollment
Unknown
Registered
2020-12-11
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-04-12

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

Control Group:Standard care
Aerosol inhalation:Standard care plus aerosol inhalation

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 70 years old; 2.The diagnostic criteria of subjects clearly defined as "SARS-CoV-2 infected pneumonia" shall be based on the criteria of severe patients stipulated in the "Novel Coronavirus Infected Pneumonia Protocol (Trial version vii)" issued by the National Health Commission; 3. Patients can receive aerosol inhalation; 4. Consent to sign a written informed statement prior to the beginning of the study.

Exclusion criteria

Exclusion criteria: 1. Pneumonia caused by other viruses, except for 2019-nCov; 2. Clear bacterial infection; 3. Subjects who have used antiviral drugs and may need another antiviral treatment during the study; 4. There are serious non-infectious pulmonary diseases, including tuberculosis, pulmonary edema and pulmonary embolism; 5. Severe liver and kidney dysfunction; 6. Participating in other clinical studies within 30 days before administration; 7. Allergic to type 1 interferon; 8. Pregnant or lactating women; 9.In any other case, if the investigator thinks it is not suitable for the trial, or it may increase the risk of the subject or interfere with the clinical trial.

Design outcomes

Primary

MeasureTime frame
Viral load;Clinical Symptoms (Fever, Cough...);Inflammation;Pulmonary imaging;In-hospital days;

Secondary

MeasureTime frame
routine blood test;blood biochemical;routine urine test;Blood oxygen;

Countries

China

Contacts

Public ContactWeihui Fu

Shanghai Public Health Clinical Center

fuweihui4011@163.com+86 18939871029

Outcome results

None listed

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