COVID-19 VaccinE Response in Rheumatology Patients

(COVER Trial)

Recruiting at 6 trial locations

Overseen By Simi Sodhi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Jeffrey Curtis

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests an extra dose of the COVID-19 vaccine in patients with autoimmune diseases. It aims to see if pausing their medications temporarily can make the vaccine more effective. The goal is to improve their immune response to COVID-19.

Research Team

Jeffrey R Curtis, MD MS MPH

Principal Investigator

Foundation for Advancing Science Technology Education and Research

Eligibility Criteria

Inclusion Criteria

Must be 18 years of age or older

Must be scheduled for an additional dose of mRNA COVID-19 vaccination booster (or with plans to schedule booster) within the next 30 days

Currently receiving one of the medications described in Table 1

Exclusion Criteria

You are taking medication that boosts your immune system for something other than rheumatologic conditions (like organ transplant).

You have received any vaccine other than COVID-19 vaccine within two weeks before your COVID-19 vaccine booster shot.

Already received a non-mRNA COVID-19 vaccine dose (J&J)

Treatment Details

Interventions

• Abatacept (Immunomodulatory Therapy)
• Baricitinib (Immunomodulatory Therapy)
• Canakinumab Injection (Immunomodulatory Therapy)
• Ixekizumab (Immunomodulatory Therapy)
• Secukinumab (Immunomodulatory Therapy)
• TNF Inhibitor (Immunomodulatory Therapy)
• Tofacitinib (Immunomodulatory Therapy)
• Upadacitinib (Immunomodulatory Therapy)

Participant Groups

Group I: Treatment Interruption - UPA Experimental Treatment 1 Intervention

Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster

Group II: Treatment Interruption - TOF Experimental Treatment 1 Intervention

Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster

Group III: Treatment Interruption - TNFi SQ Experimental Treatment 1 Intervention

Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster

Group IV: Treatment Interruption - SEC Experimental Treatment 1 Intervention

Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster

Group V: Treatment Interruption - IXE Experimental Treatment 1 Intervention

Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster

Group VI: Treatment Interruption - CAN Experimental Treatment 1 Intervention

Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster

Group VII: Treatment Interruption - BAR Experimental Treatment 1 Intervention

Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster

Group VIII: Treatment Interruption - ABA Experimental Treatment 1 Intervention

Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster

Group IX: Treatment Continuation Active Control 1 Intervention

Treatment Continuation of All Immunomodulatory Therapy at the time of COVID Vaccine Booster

Who Is Running the Clinical Trial?

Jeffrey Curtis

Lead Sponsor

Trials

1

Recruited

1,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Illumination Health

Collaborator

Trials

3

Recruited

1,300+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois