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Autoimmune DiseasesCOVADISNCT04870411

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

An observational study of Autoimmune Diseases and Inflammatory Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Autoimmune Diseases, Inflammatory Disorder
What is being tested?
Blood sample
Type of treatment
Vaccines
How many people
78 participants
Where
1 siteFrance
Study dates
12 May 2021to 13 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics = 170 patients Patients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics = 30 patients

Who may be able to join

  • Group 1 :
  • Patient over 18 years old,
  • Patient informed and not opposed to participate
  • Patient followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis)
  • Treatment with immunosuppressant and / or immunomodulator
  • Group 2 :
Show all 10Show fewer
  • Patient over 18 years old,
  • Patient informed and not opposed to participate
  • Patient not followed for an autoimmune or inflammatory disease (vasculitis, systemic lupus, systemic sclerosis, non-infectious uveitis)
  • Absence of treatment with immunosuppressant and / or immunomodulator

Who cannot join

  • Contraindication to vaccination
  • Progressive cancer
  • Pregnant or breastfeeding woman
  • Current infection less than 3 weeks old
  • Weight less than 40 kg
  • Patient under tutor- or curator-ship
  • Patient without health insurance

Trial locations and contacts

1 site in 1 country.

France1 site

  • Internal medicine Service - Cochin Hospital

    Paris, 75014

Other trials in France

About this study

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.

Read more

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.

Being tested
Blood sample
Keywords
Covid-19, vaccine, SARS-CoV2, autoimmune diseases, immunosuppressants
Medical subject headings
Autoimmune Diseases, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleBiological

    Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination

Study groups in NCT04870411
Study groupRoleWhat they receive
Patients with auto-immune or autoinflammatory diseasesPatients with auto-immune or autoinflammatory diseases treated with immunosuppressants and/or biologics
Receives: Biological: Blood sample
Patients without auto-immune or autoinflammatory diseasesPatients without auto-immune or autoinflammatory diseases and not treated with immunosuppressants and/or biologics
Receives: Biological: Blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with neutralizing antibody

    Measured: 1 month after vaccination

Secondary outcomes (23)

  1. Proportion of patients with neutralizing antibody

    Measured: 3 months after vaccination

  2. Proportion of patients with neutralizing antibody

    Measured: 6 months after vaccination

  3. Proportion of patients with neutralizing antibody

    Measured: 12 months after vaccination

  4. Proportion of patients with anti-SARS-CoV2 specific T lymphocytes

    Measured: 1 month after vaccination

  5. Proportion of patients with anti-SARS-CoV2 specific T lymphocytes

    Measured: 3 months after vaccination

  6. Proportion of patients with anti-SARS-CoV2 specific T lymphocytes

    Measured: 6 months after vaccination

  7. Proportion of patients with anti-SARS-CoV2 specific T lymphocytes

    Measured: 12 months after vaccination

  8. Proportion of patients with symptomatic infection by Covid 19 during follow-up

    Measured: 1 month after vaccination

  9. Proportion of patients with symptomatic infection by Covid 19 during follow-up

    Measured: 3 months after vaccination

  10. Proportion of patients with symptomatic infection by Covid 19 during follow-up

    Measured: 6 months after vaccination

  11. Proportion of patients with symptomatic infection by Covid 19 during follow-up

    Measured: 12 months after vaccination

  12. Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment

    Measured: 1 month after vaccination

  13. Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment

    Measured: 3 months after vaccination

  14. Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment

    Measured: 6 months after vaccination

  15. Proportion of patients with neutralizing antibody and anti-SARS-CoV2 specific T cells according to the immunosuppressive or immunomodulative treatment

    Measured: 12 months after vaccination

  16. Proportion of patients with flair of autoimmune disease

    Measured: 1 month after vaccination

  17. Proportion of patients with flair of autoimmune disease

    Measured: 3 months after vaccination

  18. Proportion of patients with flair of autoimmune disease

    Measured: 6 months after vaccination

  19. Proportion of patients with flair of autoimmune disease

    Measured: 12 months after vaccination

  20. Proportion of patients with treatment-related adverse events grade 3 or 4

    Measured: 1 month after vaccination

  21. Proportion of patients with treatment-related adverse events grade 3 or 4

    Measured: 3 months after vaccination

  22. Proportion of patients with treatment-related adverse events grade 3 or 4

    Measured: 6 months after vaccination

  23. Proportion of patients with treatment-related adverse events grade 3 or 4

    Measured: 12 months after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2021
  2. Study start12 May 2021
  3. Primary completion31 Aug 2021
  4. Study completion13 Mar 2022

Why it stopped: Most of the patients were already vaccinated

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04870411
Sponsor's protocol ID
APHP210167
Other IDs
2021-A00181-40
Acronym
COVADIS
Status last verified
Sep 2025
First submitted
26 Mar 2021
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.

    PubMed 32105632

  • Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.

    PubMed 33378609

  • Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

    PubMed 33301246

  • Sacre K, Goulenok T, Bahuaud M, Francois C, Van der Haegen MC, Alexandra JF, Aucouturier P, Hurtado-Nedelec M, Moins-Teisserenc H, Batteux F, Papo T. Impaired long-term immune protection following pneumococcal 13-valent/23-valent polysaccharide vaccine in systemic lupus erythematosus (SLE). Ann Rheum Dis. 2018 Oct;77(10):1540-1542. doi: 10.1136/annrheumdis-2017-212789. Epub 2018 Feb 14. No abstract available.

    PubMed 29444908

  • Hadjadj J, Planas D, Ouedrani A, Buffier S, Delage L, Nguyen Y, Bruel T, Stolzenberg MC, Staropoli I, Ermak N, Macraigne L, Morbieu C, Henriquez S, Veyer D, Pere H, Casadevall M, Mouthon L, Rieux-Laucat F, Chatenoud L, Schwartz O, Terrier B. Immunogenicity of BNT162b2 vaccine against the Alpha and Delta variants in immunocompromised patients with systemic inflammatory diseases. Ann Rheum Dis. 2022 May;81(5):720-728. doi: 10.1136/annrheumdis-2021-221508. Epub 2022 Jan 12.

    PubMed 35022159

Questions about this trial

What is this clinical trial studying?

An observational study of Autoimmune Diseases and Inflammatory Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Most of the patients were already vaccinated). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with neutralizing antibody (time frame: 1 month after vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04870411, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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