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VA CoronavirUs Research & Efficacy Studies-1 (VA CURES-1)

What is VA CURES-1?

VA CURES-1 is a nationwide multi-center, randomized, double-blind, placebo-controlled trial (RCT) among veterans hospitalized with COVID-19 and requiring supplemental oxygen. Whereas current therapies have improved the outcomes of patients with COVID-19, additional therapies are urgently needed to limit disease and increase survival. We are testing the effects of convalescent plasma, which is not currently an FDA-approved treatment for COVID-19.

What are the goals of VA CURES-1?

The primary goal of CURES-1 is to objectively determine whether convalescent plasma provides protection to prevent the progression to respiratory failure and death among veterans hospitalized with COVID-19 and requiring oxygen compared with the effects of a saline control.

The secondary goals are to identify which veterans are most likely to respond to convalescent plasma as well as the factors in plasma that are responsible for helping veterans to survive this serious infection.

What is convalescent plasma?

Convalescent plasma is fluid collected from the blood of volunteers who have successfully recovered from COVID-19. The plasma selected to be given in CURES-1 will have known active levels of neutralizing antibodies that inhibit the virus and, likely, other potentially beneficial factors. By inhibiting viral growth and the injury it causes, disease progression may be slowed or stopped. CURES-1 tests the assumption that convalescent plasma is superior to saline and will determine if the plasma is of benefit to veterans hospitalized with COVID-19.

How will the VA CURES-1 study be conducted?

  • In CURES-1, subjects are assigned randomly to receive intravenous plasma or saline. The assignment is blinded, so neither the Veteran nor the doctor will know which treatment has been given until the end of the study.
  • Over 700 veterans will be asked to participate at ≥ 25 VA hospitals.
  • Resources are provided to a collaborating local site investigator and study coordinator at each site.
  • Rigorous and consistent training is provided to and required of each participating site.
  • The CURES-1 trial is performed in accordance with International Conference on Harmonization Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and all applicable VA policies, regulations and procedures.
  • Rigorous statistical analyses will be applied to objectively determine whether or not convalescent is beneficial is veterans hospitalized with COVID-19.

The organizational and administrative/monitoring structure of this study will include the following components:

  • Administrative/Study Management
  • Monitoring
  • Clinical Science Research and Development
  • The Palo Alto CSPCC and the Study Chairs’ Office
  • The CSP Clinical Research Pharmacy Coordinating Center (CSPCRPCC)
  • Participating VA medical centers
  • The Executive Committee
  • The Data Monitoring Committee (DMC)
  • VA Central IRB
  • The CSP Site Monitoring, Auditing and Resource Team (SMART)

Who makes up the VA CURES-1 Leadership Team?

Position

Name and E-Mail Address

Study Chairs

Edward N. Janoff, MD

Edward.Janoff@va.gov

Sheldon T. Brown, MD

Sheldon.brown@va.gov

Steering Committee Members

Jeffrey L. Curtis, MD

Jeffrey.Curtis@va.gov

Robert Bonomo, MD

Robert.Bonomo@va.gov

National Study Coordinator

Ashlea Mayberry, BSN

Ashlea.Mayberry@va.gov

Study Biostatisticians

Mei-Chiung Shih, PhD

Mei-Chiung.Shih@va.gov

Ilana Belitskaya-Levy, PhD

Ilana.Belitskaya-Levy@va.gov

Study Project Manager

Lisa Zehm, MS

Lisa.Zehm@va.gov

Study Pharmacist

Elliott Miller, PharmD, MS

Elliott.Miller@va.gov

How can I learn more about VA CURES-1?

The CURES-1 protocol has been reviewed and approved by VA Central Institutional Review Board and CSRD Merit Review Board. It is registered on clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT04539275)

Contact the VA CURES-1 research team via email at: vacures1@va.gov



Questions about the R&D website? Email the Web Team.

Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.