In response to the COVID-19 crisis, the California Institute for Regenerative Medicine (CIRM) funded a clinical study with the following goals:
Help identify and screen potential convalescent plasma donors, analyze the antibody properties present in convalescent plasma, and determine whether these antibodies correlate with clinical outcome observed in COVID-19 patients treated with convalescent plasma.
How we are going to do it
This study is led by City of Hope in Duarte, California and the Translational Genomics Research Institute (TGen) in Flagstaff, Arizona. It is supported by a network of medical sites across California, including the CIRM-funded Alpha Stem Cell Clinics, and multiple hospitals in medically underserved communities.
To accomplish our mission, we are providing the following services at no cost:
- A rapid-response screening program to screen potential COVID-19 convalescent plasma donors, particularly in underserved communities.
- A laboratory center that can analyze the anti-SARS-CoV-2 antibodies properties in COVID-19 convalescent plasma.
- An analysis of the clinical course of the disease in COVID-19 patients to identify whether antibody properties correlate with clinical benefit of COVID-19 convalescent plasma.
What we need to fulfill our mission
To meet our goal, we are looking for COVID-19 convalescent volunteers to be screened for eligibility to donate plasma, or who are willing to donate blood to support our research efforts.
We are also looking for treating physicians who are willing to send us retaining samples from the plasma units they infuse in COVID-19 patients, and to collect blood samples and clinical data from COVID-19 patients, before and after convalescent plasma infusion.
With your help, we will develop a bank of convalescent plasma in California and learn whether and how convalescent plasma can help COVID-19 patients.
Who are we?
Our team is composed of immunology experts at City of Hope in Duarte, California, under the leadership of John A. Zaia, M.D., the Aaron D. Miller and Edith Miller Chair for Gene Therapy, and at the Translational Genomics Research Institute (TGen) in Flagstaff, Arizona, under the leadership of John Altin, Ph.D.
In late 2016, City of Hope and TGen formed an alliance to accelerate research discoveries into cures for patients. City of Hope is a leader in the fields of hematologic malignancies, bone marrow transplantation and select solid tumors, while TGen brings best-in-class genomic and informatics expertise to efficiently advance basic science for therapeutics, biomarkers and diagnostics. Together, they will be responsible for the sophisticated analysis of antibody characteristics in convalescent plasma and correlation to clinical outcomes.
This project is also supported by local institutions, including certain CIRM Alpha Stem Cell Clinics and regional medical centers.
Our clinical advisory panel includes Michael J. Joyner, M.D., from The Mayo Clinic, Evan Bloch, M.D., from Johns Hopkins School of Medicine and Sheila M. Young, M.D., from Charles R. Drew University of Medicine and Science.
Joyner is leading a national expanded access program (EAP) sponsored by the U.S. government to coordinate the collection and distribution of COVID-19 convalescent plasma for the treatment of individuals with severe or life-threatening disease.
Bloch, associate professor of immunology at Johns Hopkins, is facilitating an ongoing clinical trial using COVID-19 convalescent plasma.
Young, adjunct assistant professor, is managing the mobile COVID-19 testing site at Charles R. Drew University of Medicine and Science in South Los Angeles.
What lab tests are we performing?
We are analyzing the following samples:
- Blood samples from COVID-19 convalescent volunteers
- Retained samples from plasma units infused in COVID-19 patients
- Blood samples from COVID-19 patients, before and after infusion with convalescent plasma
We determine if there are anti-SARS-CoV-2 antibodies present in the blood of COVID-19 convalescent volunteers using an immunoassay (Positive vs. Negative). This is the only information that will be shared with convalescent volunteers. The other samples from the plasma units and COVID-19 patients will be analyzed for their concentration of SARS-CoV-2 antibodies, using a more quantitative assay. We will also determine exactly what parts of the virus are targeted by SARS-CoV-2 antibodies in each sample, using a PepSeq assay. Finally, we will assess in a petri dish the ability of anti-SARS-CoV-2 antibodies to prevent viral infection using a neutralization assay. In addition, based on the convalescent donor history, we may perform a nose/throat swab to detect the presence of SARS-CoV-2 by PCR. If the convalescent donors and COVID-19 patients agree, we will store leftover samples to perform additional studies in the future.