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Prospective, open-label, controlled, multicenter cohort study of long-acting interferon plus ribavirin in patients with novel coronavirus pneumonia (COVID-19)

Prospective, open-label, controlled, multicenter cohort study of long-acting interferon plus ribavirin in patients with COVID-19 infection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030922
Enrollment
Unknown
Registered
2020-03-17
Start date
2020-02-26
Completion date
Unknown
Last updated
2020-03-23

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

A:Long-acting interferon alpha-2a (135ug) + ribavirin
B:Abidol + ribavirin

Sponsors

Foshan First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 65 years old; (2) Patients with mild or normal type who have been diagnosed with new type of coronavirus infection [in accordance with the diagnostic criteria of the Notice on Printing and Distributing New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Implementation) issued by the National Health and Medical Commission]; (3) According to the National Health and Health Commission's antiviral treatment for more than 10 days, the COVID-19 nucleic acid examination of the throat swabs/putum /stool samples was still positive or weakly positive.

Exclusion criteria

Exclusion criteria: (1) Female patients who are pregnant or planning to become pregnant within 7 months; (2) ALT is higher than 10 times the upper limit of normal value, or total bilirubin is highter than 2 times the upper limit of normal value, or the stage of decompensation of cirrhosis, or has had decompensation of cirrhosis; (3) The number of peripheral blood leukocytes and/or platelets is lower than the lower limit of normal value; (4) There are serious important organs such as cardiovascular,lung,kidney,brain lesions and fundus lesions; (5) Combined with autoimmune disease,mental illness,diabetes,and abnormal thyroid function (hyperthyroidism or hypothyroidism); (6) Those diagnosed or suspected of malignant tumors; (7) Those who are using immunosuppressive drugs or after organ transplantation or who are preparing to undergo organ transplantation; (8) Drug addicts or people with HIV infection; (9) Those who are allergic to interferon; (10) There are other situations in which interferon is not suitable for use by the doctor in charge; (11) Men who did not take effective contraception during and after the treatment period.

Design outcomes

Primary

MeasureTime frame
COVID-19 nucleic acid negative conversion rate;Causal mortality;All-cause mortality;

Secondary

MeasureTime frame
Causal mortality;COVID-19 nucleic acid negative conversion rate;All-cause mortality;

Countries

China

Contacts

Public ContactBin Zhang/Yinong Ye

Department of Infectious Diseases, Foshan First People's Hospital

FSYYN001@126.com+86 18038860666

Outcome results

None listed

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