RESEARCH TRIANGLE PARK, NC / ACCESSWIRE / November 1, 2021 / Rho, a full-service contract research organization (CRO) with a proven track record of drug development success, today announced that it will be the Statistical and Clinical Coordinating Center for the COVID-19 Vaccine in Autoimmune Disease Non-Responders study. This clinical trial will assess the antibody response to an extra dose of an authorized or approved COVID-19 vaccine in people with autoimmune diseases who did not respond to an original COVID-19 vaccine regimen. The trial also will investigate whether pausing immunosuppressive therapy for autoimmune diseases improves the antibody response to an extra dose of a COVID-19 vaccine in this population. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and is being conducted by the NIAID-funded Autoimmunity Centers of Excellence.
"As a strategic, long-term partner of the NIH with diverse study experience and unmatched customer service, our team is honored to work on another important COVID-19 vaccine study," said Dr. Laura Helms Reece. "This study allows us to support an investigation of how best to protect this vulnerable patient population."
An estimated 8% of Americans have an autoimmune disease, including a disproportionate number of people in the minority communities most severely impacted by COVID-19. Researchers have reported higher rates of severe COVID-19 cases and death in people with autoimmune disease than in the general population. It is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both.
As the Statistical and Clinical Coordinating Center for the COVID-19 Vaccine in Autoimmune Disease Non-Responders study, Rho will provide project management, clinical monitoring, data management, statistical programming and analysis, client support, and pharmacovigilance. Rho will procure and manage vendors, including translation services (if requested), electronic Patient Reported Outcome (ePRO) (electronic diary), public-facing website, and vendors for procurement of study supplies. Rho will also provide oversight of the central clinical laboratory, ICON.
The study team will enroll approximately 600 participants ages 18 years and older at 15 to 20 sites nationwide. Participants must have had a negative or suboptimal antibody response to two doses of the Moderna COVID-19 vaccine, two doses of the Pfizer-BioNTech COVID-19 vaccine, or one dose of the Johnson & Johnson COVID-19 vaccine, all of which must have been received prior to enrollment. Participants also must be taking one of three immunosuppressive therapies: mycophenolate mofetil (MMF) or mycophenolic acid (MPA); methotrexate (MTX); or B cell-depleting drugs.
Study participants will be followed for a total of 13 months. Preliminary results are expected in mid-December 2021.
To learn more about the COVID-19 Vaccine in Autoimmune Disease Non-Responders trial, please click here.
About Rho
Rho, a privately held contract research organization (CRO) located in Research Triangle Park, NC, provides a full range of clinical research services across the entire drug development process. For more than 35 years, Rho has been a trusted partner to leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Facebook, LinkedIn and Twitter.
MEDIA CONTACT:
Kelly Maicon (on behalf of Rho)
LARGEMOUTH COMMUNICATIONS
m: 919.741.9784
kmaicon@largemouthpr.com
SOURCE: Rho
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https://www.accesswire.com/670548/Rho-to-Coordinate-NIAID-COVID19-Vaccine-Study-in-Autoimmune-Disease-NonResponders
