Efficacy and Safety of IFN-α2β in the Treatment of Novel Coronavirus Patients
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|ClinicalTrials.gov Identifier: NCT04293887|
Recruitment Status : Not yet recruiting
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Recombinant Human Interferon α1β||Drug: Recombinant human interferon α1β||Early Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||328 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||March 1, 2020|
|Estimated Primary Completion Date :||May 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Standard therapy + interferon therapy
Standard treatment + recombinant human interferon α1β 10ug Bid was administered by nebulization for 10 days.
Drug: Recombinant human interferon α1β
Saline needle 2ml + recombinant human interferon α1β10ug bid nebulization inhalation
No Intervention: Standard therapy + blank therapy
- The incidence of side effects [ Time Frame: Within 14 days after enrollment ]dyspnea
- The incidence of side effects [ Time Frame: Within 14 days after enrollment ]SPO2≤94%
- The incidence of side effects [ Time Frame: Within 14 days after enrollment ]respiratory rate ≥24 breaths/min in oxygen state)
- Time from patient enrollment to clinical remission [ Time Frame: Within 14 days after enrollment ]the patient had a normal body temperature of > for 24 hours (without taking antipyretic drugs or hormones) without self-consciousness Dyspnea or reduced dyspnea;
- Proportion of patients with normal body [ Time Frame: Within 14 days after enrollment ]Proportion of patients with normal body
- Proportion of patients without dyspnea [ Time Frame: Within 14 days after enrollment ]Proportion of patients without dyspnea
- Proportion of patients without cough [ Time Frame: Within 14 days after enrollment ]Proportion of patients without cough
- Proportion [ Time Frame: Within 14 days after enrollment ]Proportion of patients without oxygen treatment
- The negative conversion rate of new coronavirus nucleic acid [ Time Frame: Within 14 days after enrollment ]The negative conversion rate of new coronavirus nucleic acid
- Proportion [ Time Frame: within 28 days after enrollment ]Proportion of patients hospitalized/hospitalized in ICU
- Frequency of serious adverse drug events. [ Time Frame: within 28 days after enrollment ]Frequency of serious adverse drug events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293887
|Contact: Jianping Zhao, Ph.D.||13507138234||Zhaojp88@126.com|
|Contact: Huilan Zhang, Ph.D.||email@example.com|