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NCT04870411: COVADIS

Immunological Response to COVID-19 Vaccine in Patients With Autoimmune and Inflammatory Diseases Treated With Immunosuppressants and/or Biologics

Terminated Last updated 12 September 2025
What this trial tests

trial testing Blood sample in Autoimmune Diseases in 78 participants. Terminated before completion.

Timeline
12 May 2021
Primary endpoint
31 August 2021
13 March 2022

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
StatusTerminated
Study typeOBSERVATIONAL
Enrollment78
Start date12 May 2021
Primary completion31 August 2021
Estimated completion13 March 2022
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Autoimmune Diseases or Inflammatory Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Vaccination against the new coronavirus (SARS-CoV-2) was extended to patients at risk of severe forms of Covid-19, including in particular patients with autoimmune and inflammatory diseases treated by immunosuppressants and/or biologics. In this particular population, the effectiveness of vaccines, in particular influenza and pneumococcal vaccinations, is often reduced, especially in case of treatment with rituximab and / or methotrexate. Regarding the SARS-CoV-2 vaccine, the studies that allowed the marketing authorization of the available vaccines did not include patients treated with immunosuppressants or immunomodulators. Thus, the impact of treatments on the production of neutralizing antibodies and specific T lymphocytes is not known. The goal of this study is to assess the immune response to the SARS-CoV-2 vaccine in patients with autoimmune and inflammatory diseases treated with immunosuppressants or immunomodulators.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immunogenicity of BNT162b2 vaccine against the Alpha and Delta variants in immunocompromised patients with systemic inflammatory diseases.
    Hadjadj J, Planas D, Ouedrani A, Buffier S, et al · · 2022 · cited 50× · PMID 35022159 · DOI 10.1136/annrheumdis-2021-221508
  2. Longitudinal analysis of serum neutralization of SARS-CoV-2 Omicron BA.2, BA.4, and BA.5 in patients receiving monoclonal antibodies.
    Bruel T, Stéfic K, Nguyen Y, Toniutti D, et al · · 2022 · cited 47× · PMID 36450283 · DOI 10.1016/j.xcrm.2022.100850
  3. Longitudinal analysis of serum neutralization of SARS-CoV-2 Omicron BA.2, BA.4 and BA.5 in patients receiving monoclonal antibodies
    Bruel T, Stéfic K, Nguyen Y, Toniutti D, et al · · 2022 · cited 3× · DOI 10.1101/2022.08.12.22278699
  4. Immunogenicity of BNT162b2 vaccine Against the Alpha and Delta Variants in Immunocompromised Patients
    Hadjadj J, Planas D, Ouedrani A, Buffier S, et al · · 2021 · cited 2× · DOI 10.1101/2021.08.08.21261766
  5. Seroneutralization of Omicron BA.1 and BA.2 in patients receiving anti-SARS-CoV-2 monoclonal antibodies
    Bruel T, Hadjadj J, Maes P, Planas D, et al · · 2022 · cited 1× · DOI 10.1101/2022.03.09.22272066

Verify or expand the search:

Other trials of Blood sample

Trials testing the same drug.

Other recruiting trials for Autoimmune Diseases

Currently open trials in the same condition.

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04870411.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing