Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05706038
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2023-01-30
Brief Title:
Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
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:
COV-ADA
Brief Summary:
This study is a retrospective pharmacological study of a historical cohort Collection of Retrospective data from February 2020 to 30 September 2021 The index date is the date of COVID-19 positive PCR test The data will be collected until last news last clinical visit or death
There are no defined study visits In the course of the study the clinical data recorded are those corresponding to the standard medical procedure
The goal of this study is to assess the impact on continuing or stopping adalimumab treatment on the occurrence of a severe COVID-19 Coronavirus Disease 2019 in patients with Immune-Mediated Inflammatory Disease IMID during the first month after the diagnosis of SARS-CoV-2 infection
To our knowledge no comparisons have been performed between IMID patients stopping or not their maintenance treatment In the context of the COVID-19 epidemic the goal is to minimize the risk of disease flare while simultaneously minimizing the risk of severe COVID-19 In this study we hypothesized that patients treated by adalimumab for IMID might not be susceptible to severe COVID-19 disease course
There are no defined study visits In the course of the study the clinical data recorded are those corresponding to the standard medical procedure
The goal of this study is to assess the impact on continuing or stopping adalimumab treatment on the occurrence of a severe COVID-19 Coronavirus Disease 2019 in patients with Immune-Mediated Inflammatory Disease IMID during the first month after the diagnosis of SARS-CoV-2 infection
To our knowledge no comparisons have been performed between IMID patients stopping or not their maintenance treatment In the context of the COVID-19 epidemic the goal is to minimize the risk of disease flare while simultaneously minimizing the risk of severe COVID-19 In this study we hypothesized that patients treated by adalimumab for IMID might not be susceptible to severe COVID-19 disease course
Detailed Description:
Immune-mediated inflammatory disease IBD or rheumatic disease patients treated with adalimumab with positive PCR COVID-19 diagnosis will be enrolled by physicians
There will be four predefined and balanced group
1 Adalimumab withdrawal in patients with IBD
2 Adalimumab continuation in patients with IBD
3 Adalimumab withdrawal in patients with RA PsA axSpA and nrxSpA
4 Adalimumab continuation in patients with RA PsA axSpA and nrxSpA n 312 subjects for groups 13 together and 312 subjects for groups 24 together
All data will be described by percentages categorical variables and mean - standard deviation and quartiles continuous variables The median time of follow-up survival data will also be detailed for each event of interest admission to intensive care unit need to a mechanical ventilation during hospitalization death Kaplan Meier curve will describe the probability of the occurrence of a severe SARS-CoV-2 infection see primary endpoint for definition
Time to analysis - better define - time to severity of the event Occurrence yesno
There will be four predefined and balanced group
1 Adalimumab withdrawal in patients with IBD
2 Adalimumab continuation in patients with IBD
3 Adalimumab withdrawal in patients with RA PsA axSpA and nrxSpA
4 Adalimumab continuation in patients with RA PsA axSpA and nrxSpA n 312 subjects for groups 13 together and 312 subjects for groups 24 together
All data will be described by percentages categorical variables and mean - standard deviation and quartiles continuous variables The median time of follow-up survival data will also be detailed for each event of interest admission to intensive care unit need to a mechanical ventilation during hospitalization death Kaplan Meier curve will describe the probability of the occurrence of a severe SARS-CoV-2 infection see primary endpoint for definition
Time to analysis - better define - time to severity of the event Occurrence yesno
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