Last Verified: | February/29/2020 |
First Submitted: | February/14/2020 |
Estimated Enrollment Submitted: | March/1/2020 |
First Posted: | March/2/2020 |
Last Update Submitted: | March/1/2020 |
Last Update Posted: | March/2/2020 |
Actual Study Start Date: | February/29/2020 |
Estimated Primary Completion Date: | May/29/2020 |
Estimated Study Completion Date: | June/29/2020 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Experimental: Standard therapy + interferon therapy Standard treatment + recombinant human interferon α1β 10ug Bid was administered by nebulization for 10 days. | Drug: Standard therapy + interferon therapy Saline needle 2ml + recombinant human interferon α1β10ug bid nebulization inhalation |
No Intervention: Standard therapy + blank therapy Standard therapy |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: 1. Age ≥ 18 years; 2. Clinically diagnosed patients with new type of coronavirus pneumonia, including: in accordance with the criteria for suspected cases, have one of the following etiology evidence: ① Real-time fluorescence RT-PCR of respiratory specimens or blood specimens for detection of new coronavirus nucleic acid; ② Sequencing of viral genes in respiratory specimens or blood specimens, highly homologous to known new coronavirus 3. The time interval between the onset of symptoms and random enrollment is within 7 days. The onset of symptoms is mainly based on fever. If there is no fever, cough, diarrhea or other related symptoms can be used. 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. |