Ignite Creation Date:
2024-05-06 @ 2:20 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04293887
Status:
UNKNOWN
Last Update Posted:
2020-03-03
First Post:
2020-02-15
Brief Title:
Efficacy and Safety of IFN-α2β in the Treatment of Novel Coronavirus Patients
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
New coronavirus infection is an important cause of public health emergencies at home and abroad which seriously affects peoples 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 8422 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 highThere 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 MERSThe 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 Commissions 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
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 Commissions 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None