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A Randomized, Parallel Group, Single-Blind, Phase 2 Study to Evaluate the immune response of two classes of SARS-CoV-2 Vaccines (COVID-19) employed as Second Boost in Patients under current Rituximab Therapy and no humoral response after standard mRNA vaccination

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Trial Profile

A Randomized, Parallel Group, Single-Blind, Phase 2 Study to Evaluate the immune response of two classes of SARS-CoV-2 Vaccines (COVID-19) employed as Second Boost in Patients under current Rituximab Therapy and no humoral response after standard mRNA vaccination

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Sep 2023

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At a glance

  • Drugs AZD 1222 (Primary) ; Elasomeran (Primary) ; Tozinameran (Primary)
  • Indications COVID 2019 infections
  • Focus Pharmacodynamics

    • Most Recent Events

    • 08 Sep 2023 Planned number of patients changed from 60 to 68.
    • 17 Aug 2022 Results of open label extension published in the Annals of the Rheumatic Diseases
    • 13 Jan 2022 Primary endpoint (Difference in SARS-CoV-2 antibody seroconversion rate by week 4 after vaccination boost at baseline between 3rd mRNA SARS-CoV-2 (Biontech/Pfizer or Moderna) and vector SARS-CoV-2 vaccine (AstraZeneca) ) has not been met according to the results published in the Annals of the Rheumatic Diseases
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