An infusion of antibodies to COVID-19 for patients with B cell disorder, a randomized (randomized) study (COVID Compromise study).

Phase 1

• Conditions: COVID-19 disease due to an infection with SARS-CoV2-virus; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-006075-15-NL
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-19
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

•Patient is = 18 years of age, diagnosed with COVID-19 based on a positive PCR or antigen test.
•Hospitalized.
AND one of immunocompromised conditions/treatments below
B-cell inhibition related ICP
•Use of anti-CD19 or -CD20 directed antibody therapy in 6 months prior to inclusion.
•Previous or current treatment with drugs that significantly impair B cell function (e.g. ibrutinib, venetoclax, acalabrutinib, idelalisib etc) within 6 months prior to inclusion
Other immunosuppression/treatment related ICP
•Patients treated with bendamustine, purine analogues or anti-thymocyte globulin within 6 months prior to inclusion.
•Solid organ transplant patients that are taking systemic immunosuppressive drugs from at least three pharmacological classes.
Cellular therapy related ICP
•Allogeneic hematopoietic stem cell transplant (HSCT) in 12 months prior to inclusion.
•HSCT for which systemic therapy against graft-versus-host-disease is used.
•Recipient of CAR-T cells < 2 years prior to inclusion.
Disease related ICP
•Chronic B-cell leukemia´s: CLL, HCL, PLL, multiple myeloma, Waldenströms macroglobulinemia
Congenital ICP
•Congenital disorder resulting in severe B-cell dysfunction or depletion requiring immunoglobulin suppletion (e.g. agammaglobulinemia).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

Exclusion Criteria

•Has previously participated in this study.
•Has previously received convalescent plasma with high level neutralizing anti-SARS-CoV-2 antibodies (either in other study or in compassionate use program).
•Known hypersensitivity to treatment with immunoglobulins (WHO grade 3-4).
•Patient who has reached endpoint already at admission (direct adjunctive oxygen therapy in the form of high-flow nasal oxygen (HFNO), mechanical ventilation or ICU admission for other reason).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified