A randomized, open label, parallel controlled trial of evaluating the efficacy of recombinant cytokine gene-derived protein injection for clearing novel coronavirus in patients with novel coronavirus pneumonia (COVID-19)

A randomized, open label, parallel controlled trial for evaluating the efficacy of recombinant cytokine gene-derived protein injection on clearing novel coronavirus in patients with novel coronavirus pneumonia (COVID-19)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029496

Enrollment

Unknown

Registered

2020-02-03

Start date

2020-01-29

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

Intervention A:On the basis of routine medical treatment, the patients were given Novaferon Atomization inhalation, 20ug each time, twice a day, 7-14 days.

intervention B:On the basis of routine medical treatment, the patients were given lopinavir / ritonavir tablets (Kaletra) twice a day, twice each time, 7-14 days.

intervention C:On the basis of routine medical treatment, combined with Novafron and Kaletra, the usage and course of treatment are the same as above.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) aged 18 to 70 years; (2) Light and heavy patients with new coronavirus infection confirmed by etiology.

Exclusion criteria

Exclusion criteria: (1) any situation in which the program cannot proceed safely; (2) allergic constitution; (3) serious basic diseases affecting survival, including uncontrolled malignant tumors with multiple metastases that cannot be resected, blood diseases, malignant fluid, active bleeding, severe malnutrition, HIV, etc.; The main organ function is abnormal (4) liver function was obviously abnormal: ALT/AST increased by more than 5 times the normal upper limit, increase of total bilirubin more than 2 times of normal upper limit; (5) obstructive pneumonia, severe pulmonary fibrosis, alveolar proteinosis and allergic alveolitis caused by lung tumors; (6) pregnancy: positive pregnancy test for women of child-bearing age; (7) the patient may be transferred to a non-participating hospital within 72h; (8) continuous use of immunosuppressants or organ transplants within the past 6 months; (9) in vitro life support patients (ECMO, ECCO2R, RRT); (10) expected survival no more than 48 hours.

Design outcomes

Primary

Measure	Time frame
novel coronavirus nucleic acid clearance rate;	—

Secondary

Measure	Time frame
time till the SARS-CoV-2 clearance;	—

Countries

China

Contacts

Public ContactGong Guozhong

The Second Xiangya Hospital of Cental South University

gongguozhong@csu.edu.cn+86 13873104819

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026