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A single-center,random,single-blind clinical research in SARS-CoV-2 infected patient to evaluate the effectiveness and safety by inhalating recombinant human interferon alpha2b aerosol

A single-center,random,single-blind clinical research in SARS-CoV-2 infected patient to evaluate the effectiveness and safety by inhalating recombinant human interferon alpha2b aerosol

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062797
Enrollment
Unknown
Registered
2022-08-19
Start date
2022-10-24
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

COVID-19

Interventions

Intervention group:Inhalation of Recombinant human interferon alpha2b aerosol
Control group:Inhalation of saline

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. 18 years old at least. 2. Tested positive for SARS-CoV-2 and categorized as mild,moderate or non-symptomatic SARS-CoV-2 infector according to the Ver.9 guild book for COVID-19. 3. Subject must committed to take specified contraception. 4. Subject must sufficiently understand the research progress. 5. ICF which approved by ethic committee must be signed. 6. Subject must commit to obey the requirement from researchers.

Exclusion criteria

Exclusion criteria: 1. Subject has much probability to proceed to severe or critical COVID-19. 2. Conducting or about to conduct mechanical ventilation. 3. With infection other than COVID-19. 4. HIV infector. 5. ALT/AST>1.5 ULN in screening period. 6. Allergy to any ingredient in investigation therapy. 7. Subject with any medical condition that unsuitable for this trial. 8. Subject accepted therapy that probably interfere the evaluation of investigation therapy. 9. Subject accepted plasma therapy. 10. Subject has been enrolled in clinical trials in 30 days. 11. Subject isn't thought compatible with currently on-going clinical trials. 12. Female subject in pregnancy of breast-feeding period or having plan to have a baby. 13. Couple of male subject is planing to have a baby.

Design outcomes

Primary

MeasureTime frame
Time to turn negative for SARS-CoV-2 test;

Secondary

MeasureTime frame
Comprehensive safety;

Countries

China

Contacts

Public ContactXiaohong Fan

Shanghai Public Health Clinical Center

fanxiaohong@shphc.org.cn+86 18916081980

Outcome results

None listed

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