Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04828564
Status:
UNKNOWN
Last Update Posted:
2021-04-02
First Post:
2021-04-01
Brief Title:
Efficacy and Safety of Favipiravir and Ribavirin Formulation for Treatment of COVID-19
Sponsor:
The Scientific and Technological Research Council of Turkey
Organization:
The Scientific and Technological Research Council of Turkey
Study Overview
Official Title:
An Open-Label Multicenter Parallel-Group Randomized Phase IIIII Study to Evaluate the Efficacy and Safety of Favipiravir and Ribavirin Formulation for Treatment of COVID-19
Status:
UNKNOWN
Status Verified Date:
2021-04
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:
COVID-19
Brief Summary:
This is a national multicenter open-label randomized phase IIIII trial that evaluates the efficacy and safety of favipiravir and ribavirin in the treatment of patients with confirmed COVID-19 observed within 72 hours Approximately 100 patients will be randomized in 11 ratio and divided into two groups
Detailed Description:
The clinical picture of COVID-19 disease is in a broad spectrum which includes asymptomatic infection a mild upper respiratory tract infection respiratory failure and even severe viral pneumonia with death The alarming levels of spread and severity of COVID-19 caused a global emergency and this outbreak has been characterized as a pandemic by the World Health Organization WHO
Coronavirus entry into host cells is an important determinant of viral infectivity and pathogenesis SARS-CoV S1 contains a receptor-binding domain RBD that specifically recognizes angiotensin-converting enzyme 2 ACE2 as its receptor SARS-CoV spike needs to be proteolytically activated at the S1S2 boundary such that S1 dissociates and S2 undergoes a dramatic structural change These SARS-CoV entry-activating proteases include cell surface protease TMPRSS2 and lysosomal proteases cathepsins These features of SARS-CoV entry contribute to its rapid spread and severe symptoms and high fatality rates of infected patients
Ribavirin is a guanosine analog that interferes with the replication of RNA and DNA viruses Ribavirin was used during the Severe Acute Respiratory Syndrome SARS outbreak in combination with corticosteroids which have an anti-inflammatory effect Favipiravir is a substrate for viral RNA-dependent RNA polymerase RdRp and showed anti-influenza virus activity Favipiravir is effective against other RNA viruses poliovirus rhinovirus and respiratory syncytial virus and evaluated and developed as a broad spectrum anti-RNA virus drug including lethal RNA virus infections
According to national guidelines Favipiravir treatment is applied to COVID-19 infection in Turkey The main purpose of this study is to obtain efficacy and safety data for ribavirin and favipiravir in the Turkish patient cohort diagnosed with COVID-19
This study designed as an open-label multicenter parallel-group randomized phase IIIII clinical drug trial
This study will be conducted in 4 sites
Coronavirus entry into host cells is an important determinant of viral infectivity and pathogenesis SARS-CoV S1 contains a receptor-binding domain RBD that specifically recognizes angiotensin-converting enzyme 2 ACE2 as its receptor SARS-CoV spike needs to be proteolytically activated at the S1S2 boundary such that S1 dissociates and S2 undergoes a dramatic structural change These SARS-CoV entry-activating proteases include cell surface protease TMPRSS2 and lysosomal proteases cathepsins These features of SARS-CoV entry contribute to its rapid spread and severe symptoms and high fatality rates of infected patients
Ribavirin is a guanosine analog that interferes with the replication of RNA and DNA viruses Ribavirin was used during the Severe Acute Respiratory Syndrome SARS outbreak in combination with corticosteroids which have an anti-inflammatory effect Favipiravir is a substrate for viral RNA-dependent RNA polymerase RdRp and showed anti-influenza virus activity Favipiravir is effective against other RNA viruses poliovirus rhinovirus and respiratory syncytial virus and evaluated and developed as a broad spectrum anti-RNA virus drug including lethal RNA virus infections
According to national guidelines Favipiravir treatment is applied to COVID-19 infection in Turkey The main purpose of this study is to obtain efficacy and safety data for ribavirin and favipiravir in the Turkish patient cohort diagnosed with COVID-19
This study designed as an open-label multicenter parallel-group randomized phase IIIII clinical drug trial
This study will be conducted in 4 sites
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