Clinical trial
Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse
Name
COV-ADA
Description
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.
Trial arms
Trial start
2022-04-27
Estimated PCD
2022-10-31
Trial end
2022-10-31
Status
Completed
Treatment
Adalimumab
Adalimumab is a fully human, high-affinity, recombinant anti-tumor necrosis factor (TNF) alpha monoclonal antibody used to treat rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn disease, ulcerative colitis, etc.
Adalimumab is a fully human, high-affinity, recombinant immunoglobulin G (IgG) anti-TNF alpha monoclonal antibody. It is a molecule comprising 1330 amino acids and has a molecular weight of approximately 148 kDa.\[4\] It inhibits the binding of TNF alpha (both soluble and membrane-bound) to its receptor. Specifically, it inhibits TNF alpha's interaction with p55 (TNFR1) and p75 (TNFR2) cell surface TNF receptors, which in turn interferes with cytokine-driven inflammatory processes. It is identical in structure and function to the naturally occurring human IgG1 and thus has high selectivity for TNF alpha and has low immunogenic potential.
Size
49
Primary endpoint
composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death
first month after the diagnosis of SARS-CoV-2 infection
Eligibility criteria
Inclusion Criteria:
1. age ≥ 18 years
2. diagnosis of immune-mediated inflammatory disease:
1. IBD: CD, UC or undetermined colitis
2. Rheumatic diseases: RA, PsA, axSpA, and nrx SpA
3. patients treated with adalimumab for IMID at time of SARS-CoV-2 infection diagnosis
4. COVID-19 positive PCR test
5. minimum treatment duration on adalimumab of 3 months before SARS-CoV-2 infection diagnosis
6. minimum follow-up of one month after SARS-CoV-2 infection diagnosis
Exclusion Criteria:
1. Adalimumab withdrawal for other reasons than SARS-CoV-2 infection
2. Patients with COPD or lung co-morbidities
3. Pregnant, parturient, or breastfeeding woman
4. Minor person (non-emancipated)
5. Adult person under legal protection (any form of public guardianship)
6. Adult person incapable of giving consent and not under legal protection
7. Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}
Updated at
2023-01-31
1 organization
Organization
IRCCS San Raffaele