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NCT04881396: ROMANOV
Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine
trial testing Evaluation of the immunogenicity of the vaccine in haemodialysis patients in COVID-19 Vaccines in 99 participants. Completed in 15 February 2022.
15 February 2022
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 99 |
| Start date | 10 May 2021 |
| Primary completion | 15 February 2022 |
| Estimated completion | 15 February 2022 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Evaluation of the immunogenicity of the vaccine in haemodialysis patients — full drug profile →
Conditions studied
- COVID-19 Vaccines — all drugs for COVID-19 Vaccines →
- Hemodialysis Complication — all drugs for Hemodialysis Complication →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
Adults 18 to 130, any sex, with COVID-19 Vaccines or Hemodialysis Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). However, vaccine efficiency is known to be decreased in haemodialysis patients. This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in haemodialysis patients. The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in haemodialysis patients.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A prospective observational study for justification, safety, and efficacy of a third dose of mRNA vaccine in patients receiving maintenance hemodialysis.
Espi M, Charmetant X, Barba T, Mathieu C, et al · · 2022 · cited 72× · PMID 34856313 · DOI 10.1016/j.kint.2021.10.040 -
SARS-CoV-2 vaccination in patients receiving kidney replacement therapies: where are we now with the protective immune response?
Toapanta N, Bestard O, Soler MJ. · · 2021 · cited 5× · PMID 34289072 · DOI 10.1093/ndt/gfab227 -
Justification, safety, and efficacy of a third dose of mRNA vaccine in maintenance hemodialysis patients: a prospective observational study
Espi M, Charmetant X, Barba T, Pelletier C, et al · · 2021 · cited 2× · DOI 10.1101/2021.07.02.21259913
Verify or expand the search:
- PubMed search for NCT04881396
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COVID-19 Vaccines
Currently open trials in the same condition.
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- NCT05096260 — Getting to Yes, Michigan! (G2YMI) · NA · active not recruiting
Other Hospices Civils de Lyon trials
Trials by the same sponsor.
- NCT07569536 — Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock · Phase 3 · not yet recruiting
- NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
- NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
- NCT07474532 — Attitudes and Beliefs Related to Benzodiazepine Deprescribing · not yet recruiting
- NCT07313007 — Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04881396 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 10 May 2022
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/NCT04881396.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing