Status:
UNKNOWN
Efficacy and Safety of IFN-α2β in the Treatment of Novel Coronavirus Patients
Lead Sponsor:
Tongji Hospital
Conditions:
COVID-19
Recombinant Human Interferon α1β
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
This study is a multi-center, randomized, open, blank-controlled, multi-stage clinical study. As there are no effective treatments, the project team will evaluate possible treatments (including but no...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- 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
- 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
- Any situation where the programme cannot be carried out safely;
- Patients who have used interferon or remedesivir;
- No clinical manifestations and chest imaging findings
- Known allergy or hypersensitivity to interferon (including asthma);
- Disabled in patients with uncontrolled autoimmune diseases;
- Patients with severe heart disease, decompensated liver disease, renal insufficiency (CrCL \<50ml / min), and those with abnormal bone marrow function are prohibited;
- Epilepsy and impaired central nervous system function;
- Pregnancy: Positive pregnancy test for women of childbearing age;
- Breastfeeding women have not stopped breastfeeding;
- The patient may be transferred to a non-participating hospital within 72 hours.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2020
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT04293887
Start Date
March 1 2020
End Date
June 30 2020
Last Update
March 3 2020
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