Clinical trial NCT04293887: Efficacy and Safety of IFN-α2β in the Treatment of Novel Coronavirus Patients
Official title: Randomized, Open, Blank Control Study on the Efficacy and Safety of Recombinant Human Interferon α1β in the Treatment of Patients With New Type of Coronavirus Infection in Wuhan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: COVID-19
Recombinant Human Interferon α1β
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 not limited to interferon α) based on actual conditions. , Lopinavir / ritonavir, remdesivir, single / polyclonal antibodies against coronavirus), explore the most effective antiviral treatment options.

The first phase will assess the efficacy and safety of interferon alpha compared to standard treatment for approximately 328 hospitalized adult patients diagnosed with a new coronavirus infection in Wuhan.

Patients with COVID-19 within 7 days of onset of symptoms were screened and randomly assigned as soon as possible after screening (within 24 hours). Patients will be allocated in a 1: 1 ratio, receiving the interferon alpha treatment group or only the standard treatment group. Patients who do not meet the inclusion and exclusion criteria are only allowed to be re-screened once, provided that the time from symptom onset to randomization remains within 7 days.

This study planned to randomize approximately 328 adult subjects. It will be stratified according to whether the onset time is ≤ 3 days, and randomly divided into groups of 1: 1, receiving standard treatment or interferon alpha atomization twice a day, 1 stick (10ug) each time, treatment course For 10 days. Subjects and all research center staff were not blinded.

The primary endpoint of this study was the incidence of side effects within 14 days of enrollment. Therefore, a 14-day visit is essential for the data needed for this endpoint. Every effort should be made to ensure that this study visit is completed in a timely manner.

Out-of-hospital treatment or discharge will reach the discharge standard on the day of implementation and will be implemented in accordance with the Health and Medical Commission's "Unknown Viral Pneumonia Diagnosis and Treatment Plan (Trial)". For patients treated outside the hospital or who have been discharged, final assessments are performed by phone and using a questionnaire (if applicable).

Eligibility 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.

Primary outcomes:
measure: The incidence of side effects
timeFrame: Within 14 days after enrollment
measure: The incidence of side effects
timeFrame: Within 14 days after enrollment
measure: The incidence of side effects
timeFrame: Within 14 days after enrollment
Secondary outcomes:
measure: Time from patient enrollment to clinical remission
timeFrame: Within 14 days after enrollment
measure: Proportion of patients with normal body
timeFrame: Within 14 days after enrollment
measure: Proportion of patients without dyspnea
timeFrame: Within 14 days after enrollment
measure: Proportion of patients without cough
timeFrame: Within 14 days after enrollment
measure: Proportion
timeFrame: Within 14 days after enrollment
measure: The negative conversion rate of new coronavirus nucleic acid
timeFrame: Within 14 days after enrollment
measure: Proportion
timeFrame: within 28 days after enrollment
measure: Frequency of serious adverse drug events.
timeFrame: within 28 days after enrollment
Other outcomes:
Locations:
Study officials:
References:
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