A Multicenter, Randomized, Controlled trial for Recombinant Super-Compound Interferon (rSIFN-co) in the Treatment of 2019 Novel Coronavirus (2019-nCoV) Infected Pneumonia

A Multicenter, Randomized, Controlled trial for Recombinant Super-Compound Interferon (rSIFN-co) in the Treatment of Novel Coronavirus (2019-nCoV) Pneumonia

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029638

Enrollment

Unknown

Registered

2020-02-08

Start date

2020-02-10

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Novel Coronavirus (2019-nCoV) Pneumonia

Interventions

Treatment group:baseline antiviral treatment (lopinavir / ritonavir or abidol) and inhaled with rSIFN-co

Control group:baseline antiviral treatment (lopinavir / ritonavir or abidol) and inhaled with interferon-a

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years; 2. Real-time fluorescent RT-PCR for respiratory or blood specimens to detect novel coronavirus nucleic acid positive; 3. The sequence of virus genes in respiratory or blood samples was highly homologous with the known novel coronavirus; 4. A common or severe type of new type of coronavirus pneumonia was diagnosed. The common patients diagnosed with novel coronavirus pneumonia that have fever, respiratory symptoms, and imaging shows pneumonia. Some severe patients could be included. Accord with any of the following: (1) Respiratory distress, RR >= 30 times / minute; (2) In resting state, means oxygen saturation <= 93%; (3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <= 300mmHg.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients who cannot be inhaled by atomization; 3. Patients who are intolerant or allergic to interferon preparations; 4. Other patients were judged unsuitable for inclusion in the trial by researchers.

Design outcomes

Primary

Measure	Time frame
disease remission;time to clinical improvement;overall rates of clinical improvement assessed at days 7, 14, and 28;time to chest CT improvement; time to virus nucleic acid negative-conversion;overall rates of radiological improvement on days 7, 14, and 28;overall rates of virus nucleic acid negative-conversion on qRT-PCR in nasopharyngeal swabs samples on days 7, 14, and 28;serious adverse events;	—

Measure

Time frame

disease remission;time to clinical improvement;overall rates of clinical improvement assessed at days 7, 14, and 28;time to chest CT improvement; time to virus nucleic acid negative-conversion;overall rates of radiological improvement on days 7, 14, and 28;overall rates of virus nucleic acid negative-conversion on qRT-PCR in nasopharyngeal swabs samples on days 7, 14, and 28;serious adverse events;

—

Secondary

Measure	Time frame
time to discharge;mortality;deterioration rate;adverse events;	—

Countries

China

Contacts

Public ContactLunxu Liu

West China Hospital, Sichuan University

lunxu_liu@aliyun.com+86 18980601525

Outcome results

None listed

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