COVID-19 Infection in Patients Receiving Anti-CD20 Therapy

NCT04884477 | Completed

• 1 other identifier: 21-001374
• Study Type: observational
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to determine if patients with compromised B-cell function due to anti-CD20 therapy and newly diagnosed COVID-19 infection benefit from convalescent plasma.

Conditions

COVID-19; Immunosuppressed Host; Convalescent Plasma; Anti-CD20 Therapy

Keywords

COVID-19; anti-CD20 therapy; convalescent plasma

Outcome Measures

Primary Outcomes (1)

• Change in WHO Clinical Progression scale

  In this observational study examining the use of convalescent plasma (CP) for treatment of CD20-depleted patients with COVID-19, we will describe the clinical course of these patients and conduct a comparative treatment analysis. "Time zero" will be considered the date the patient first tested positive for COVID-19, and the time-dependent nature of CP transfusion will be explicitly used in the analysis. The primary outcome of interest is the WHO ordinal outcome score measured repeatedly over 90-day follow-up. The WHO ordinal scale for Clinical Improvement ranges from 0 uninfected to 8 for Dead. Lower scores are seen with better clinical outcomes.

  90 days

Secondary Outcomes (2)

• 90-day mortality

  90 days

• ICU-free days

  90 days

Study Arms (2)

COVID-19 with previous anti-CD20 therapy and Convalescent plasma

Patients with COVID-19, treated in the past 3 years with anti-CD20 therapy and who received Convalescent plasma in addition to standard treatment for COVID-19

Biological: Convalescent Plasma

COVID-19 with previous anti-CD20 therapy and no convalescent plasma

Patients with COVID-19, treated in the past 3 years with anti-CD20 therapy treated with standard COVID-19 treatment and who did not receive Convalescent plasma treatment for COVID-19

Interventions

Convalescent Plasma BIOLOGICAL

Convalescent Plasma

COVID-19 with previous anti-CD20 therapy and Convalescent plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients hospitalized in any hospital of the Mayo Clinic Enterprise and enrolled in the Mayo Clinic COVID-19 registry.

You may qualify if:

• Diagnosis of COVID-19 infection
• Positive SARS CoV2 PCR
• Enrolled in the Mayo Clinic COVID-19 registry
• History of treatment with anti-CD20 drugs within past 3 years

You may not qualify if:

• Patients who declined to have their chart reviewed for research purpose.
• Patients who have received convalescent plasma within the previous 3 months of COVID-19 diagnosis
• Patients who have received monoclonal antibodies that target SARS-CoV-2 in the past three months

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mary Kasten, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 13, 2021
• Study Start: June 1, 2021
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)