Efficacy and Safety of IFN-α2β in the Treatment of Novel Coronavirus Patients

• Status: Not yet recruiting
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

New coronavirus infection is an important cause of public health emergencies at home and abroad, which seriously affects people's health and social stability. The outbreak of SRAR-COV in China in 2003 caused serious social impact. From January 2002 to August 7, 2003, there were a total of 8,422 cases worldwide, involving 32 countries and regions, of which 919 cases were fatal, with a fatality rate of nearly 11%. The fatality rate of elderly patients and patients with underlying diseases was even more high.There is no precise and effective treatment for coronavirus infection. In vitro, IFN-α2β has inhibitory effects on MERS-CoV and closely related coronavirus severe acute respiratory syndrome (SARS) -CoV. A study showed the effects of interferon-α2β and ribavirin on the replication of nCoV isolates hCoV-EMC / 2012 in Vero and LLC-MK2 cells. The combined application may be useful for the management of patients with nCoV infection in the future. At present, the combination therapy of interferon α2β and ribavirin has been successfully applied in the initial treatment and prevention of SARS and MERS.The purpose of this study was to evaluate the efficacy and safety of recombinant human interferon α1β in treating patients with new coronavirus infection in Wuhan.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tongji Hospital
• Treatments: Interferons

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.