Randomized, open, blank controlled trial for the efficacy and safety of recombinant human interferon alpha 1beta in the treatment of Wuhan patients with novel coronavirus pneumonia (COVID-19)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000030480

Enrollment

Unknown

Registered

2020-03-03

Start date

2020-03-03

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

Interferon Therapy Group:Standard treatment + cerrokin (recombinant human interferon alpha 1beta) 10UG BID is administered by nebulization for 10 days.

Control group:Standard treatment + blank

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Clinically diagnosed patients with COVID-19, including: on the basis of meeting the criteria for suspected cases, one of the following etiology evidence: (1) real-time fluorescent RT-PCR detection of SARS-Cov-2 nucleic acid samples in respiratory or blood samples; (2) Sequencing of viral genes in respiratory specimens or blood specimens, highly homologous to known SARS-Cov-2; 3. The interval between the onset of symptoms and random enrollment is within 7 days. The onset of symptoms is mainly based on fever. Cough, diarrhea or other related symptoms can be used for the evidence of onset symptoms if without fever.

Exclusion criteria

Exclusion criteria: 1. Any situation where the programme cannot be carried out safely; 2. Patients who have used interferon or remedesivir; 3. No clinical manifestations and chest imaging findings; 4. Known allergy or hypersensitivity to interferon (including asthma); 5. Disabled in patients with uncontrolled autoimmune diseases; 6. Patients with severe heart disease, decompensated liver disease, renal insufficiency (CrCL <50ml / min), and those with abnormal bone marrow function are prohibited; 7. Epilepsy and impaired central nervous system function; 8. Pregnancy: Positive pregnancy test for women of childbearing age; 9. Breastfeeding women have not stopped breastfeeding; 10. The patient may be transferred to a non-participating hospital within 72 hours.

Design outcomes

Primary

Measure	Time frame
Incidence of side effects;	—

Countries

China

Contacts

Public ContactHuilan Zhang

Department of Respiratory and Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

huilanz_76@163.com+86 15391532171

Outcome results

None listed

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