Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Rheumatic Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs Ospedale San Raffaele

Milan, 20132, Italy

About this study

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:

Adalimumab withdrawal in patients with IBD
Adalimumab continuation in patients with IBD
Adalimumab withdrawal in patients with RA, PsA, axSpA, and nrxSpA
Adalimumab continuation in patients with RA, PsA, axSpA, and nrxSpA n = 312 subjects for groups 1+3 together and 312 subjects for groups 2+4 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 (yes/no)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age ≥ 18 years
diagnosis of immune-mediated inflammatory disease:

IBD: CD, UC or undetermined colitis
Rheumatic diseases: RA, PsA, axSpA, and nrx SpA
patients treated with adalimumab for IMID at time of SARS-CoV-2 infection diagnosis
COVID-19 positive PCR test
minimum treatment duration on adalimumab of 3 months before SARS-CoV-2 infection diagnosis
minimum follow-up of one month after SARS-CoV-2 infection diagnosis

Exclusion criteria

Adalimumab withdrawal for other reasons than SARS-CoV-2 infection
Patients with COPD or lung co-morbidities
Pregnant, parturient, or breastfeeding woman
Minor person (non-emancipated)
Adult person under legal protection (any form of public guardianship)
Adult person incapable of giving consent and not under legal protection
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.

Treatment and study plan

Adalimumab

Drug

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.

Primary outcomes

composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death

Time frame: first month after the diagnosis of SARS-CoV-2 infection

The primary endpoint is the occurrence of a severe SARS-CoV-2 infection, which will be defined by a composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death, during the first month after the diagnosis of SARS-CoV-2 infection.

Secondary outcomes

occurrence of IMID flare

Time frame: from diagnosis of SARS-CoV-2 infection to enrollment

to measure the occurrence of IMID flare, which will be assessed by the occurrence of a disease flare until last clinical visit, to evaluate risk factors for severe COVID-19, and to evaluate risk factors for IMID flare. IMID flare is defined by patient requiring medical intervention (additional treatment and/or dose escalation and/or surgery and/or hospitalization).

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: COV-ADA

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jan 31, 2023
Registry last updated: Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed