Skip to content

A multicenter, randomized, open, controlled clinical study to evaluate the efficacy and safety of recombinant cytokine gene-derived protein injection in combination with standard therapy in patients with novel coronavirus infection

A multicenter, randomized, open, controlled clinical study to evaluate the efficacy and safety of recombinant cytokine gene-derived protein injection in combination with standard therapy in patients with novel coronavirus infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029573
Enrollment
Unknown
Registered
2020-02-05
Start date
2020-02-06
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

Interventions

Mild Type Group A:antiviral therapy and Chinese medicine treatment
Mild Type Group B:antiviral therapy, Chinese medicine treatment, and Novaferon atomization
Common and Heavy Type Group C:antiviral therapy and Chinese medicine treatment
Common and Heavy Type Group C:antiviral therapy, Chinese medicine treatment, and Novaferon atomization

Sponsors

The First Affiliated Hospital of Medical College of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: o be enrolled, all the following criteria must be met: 1) the confirmed patient (or legal guardian) agrees to participate in the study and signs the informed consent; 2) Aged 18-65 years, gender not limited; 3) the time interval between symptom onset and random enrollment was within 8 days (symptom onset was mainly determined by the time of fever); 4) real-time fluorescence rt-pcr detection of respiratory tract or blood samples in patients with positive nucleic acid of novel coronavirus; 5) diagnosis of mild, common or severe cases according to the diagnosis and treatment plan for pneumonia caused by novel coronavirus (trial version 5): A. Mild: the clinical symptoms were mild, and no pneumonia was found on imaging; B. Common type: symptoms such as fever and respiratory tract, and manifestations of pneumonia can be seen on imaging; C. Heavy: meets any of the following: A. respiratory distress, respiratory frequency >= 30 times/min; B. At rest, oxygen saturation (SaO2) <= 93%; C. Arterial partial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <= 300mmHg.

Exclusion criteria

Exclusion criteria: You cannot be enrolled if you meet any of the following criteria: 1) any situation that cannot allow the program to proceed safely; 2) allergic constitution, allergic to more than one kind of food or medicine; 3) patients with severe basic diseases that affect survival, including uncontrolled clinically significant heart, lung, kidney, digestion, blood diseases, neuropsychiatric diseases, immune diseases, metabolic diseases, malignant tumors, and severe malnutrition; 4) pregnant or lactating women; 5) patients may be transferred to non-participating hospitals within 72 hours; 6) patients who have been on immunosuppressive agents or organ transplants for nearly 6 months; 7) critically ill patients diagnosed according to the diagnosis and treatment plan for pneumonia caused by novel coronavirus infection (trial fifth edition); 8) those who are unable to cooperate in mental state, suffer from mental illness, have no self-control and cannot express clearly; 9) a history of HBV, HCV, TPPA, HIV and pancreatitis before infection; 10) participants in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The time required for RNA Yin conversion of novel coronavirus in respiratory or blood specimens was compared between treatment groups The difference of;

Secondary

MeasureTime frame
Differences in mean clinical recovery time between treatment groups were compared;The proportion of subjects for the novel coronavirus RNA in respiratory or blood samples at day 7 of treatment was compared between treatment groups;RNA negative ratio of subjects for The novel coronavirus in respiratory or blood samples at day 14 of treatment was compared between treatment groups;In the light cohort, the proportion of subjects who progressed to pneumonia at day 7 of treatment was compared between treatment groups;Pneumonia severity index at day 14 of treatment was compared between treatment groups in the general and heavy cohort (PSI) differences, chest imaging differences (chest CT);In normal subjects,the ratio of subjects who progressed to severe pneumonia on day 14 of treatment were compared between treatment groups;In normal and heavy queues,the ration of Progression to critical pneumonia at day 14 of treatment were compared between treatment groups;The proportion of subjects who died of illness at day 28 and day 84 were compared between treatment groups;

Countries

China

Contacts

Public ContactLi Lanjuan

The First Affiliated Hospital of Medical College of Zhejiang University

ljli@zju.edu.cn+86 13906514210

Outcome results

None listed

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