What you need to know
Hackensack Meridian Health has treated 1,000 patients in it’s COVID-19 clinical trials.
From antiviral drugs to immunotherapies, to the potential treatment properties of antibodies in the blood of COVID-19 survivors, the patients have been treated over the course of 10 clinical trials, as well as through compassionate use and expanded use access. The trials include treatments from major pharmaceutical companies as well as investigator-initiated research aimed at turning the tide against the coronavirus pandemic.
At Hackensack Meridian Health, the number of patients receiving access to these latest treatments is expected to grow with enrollments in the coming days and weeks.
The trials include:
- CYNK-001. The CYNK-001 immunotherapy made by Celularity, Inc. is aimed at bolstering patients’ immune response, and is approved in cancer applications. The U.S. Food and Drug Administration also recently authorized the therapy as an investigational new drug for use in adult COVID-19 patients, amid the spreading pandemic. John Theurer Cancer Center will be the first site in the Phase I/II clinical trial, which will assess its effectiveness in treating infected patients. Hackensack Meridian Health is the first to test this therapy for COVID-19.
- Remdesivir. An antiviral drug developed by Gilead Sciences to respond to Ebola and Marburg viruses, the therapy is currently being investigated at five sites: Hackensack University Medical Center, Jersey Shore University Medical Center, JFK Medical Center, Bayshore Medical Center, and Ocean Medical Center (totaling three trials). HUMC is conducting two Phase III trials, one evaluating the safety and effectiveness in severe COVID-19 cases, and the other in moderate cases as compared to standard of care. JFK, Jersey Shore, Bayshore, and Ocean are conducting an expanded access treatment protocol in the hospital for the coronavirus cases. Additionally, across the network compassionate use of the drug is allowed in pediatric and pregnant cases.
- Acalabrutinib. A medicine approved to treat mantle cell lymphoma, a kind of non-Hodgkin’s lymphoma, and made by AstraZeneca is also being tested. Hackensack Meridian Health is the first to test this kinase inhibitor.
- Sarilumab. A monoclonal antibody by Regeneron intended for arthritis treatments is being tested. The adaptive, Phase II/III, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of the treatment in COVID-19 patients is open and enrolling at Hackensack University Medical Center, JFK Medical Center, and Jersey Shore University Medical Center.
- Tocilizumab. An immunosuppressive drug used to treat arthritis manufactured by Genentech. The trial at HMH enrolled patients at Hackensack University Medical Center.
- Hydroxychloroquine. The immunosuppressive drug used to treat and prevent malaria was investigated at JFK Medical Center as a COVID-19 preventative among high-risk healthcare workers. Patients are no longer being enrolled in this trial.
- Convalescent plasma – Hackensack. HUMC is recruiting recovered and recovering COVID-19 patients to test their blood for antibodies in response to the virus. Patients with promising titers of antibodies will be asked to donate plasma, which may be helpful for sick COVID-19 patients. This trial is unique to HUMC.
- Convalescent plasma – network-wide. Sites across the Hackensack Meridian Health network are taking part in the FDA/Red Cross-led National Expanded Access Program.
The trials have specific criteria, following various guidelines at different phases of the investigational process, and are under the guidance of the Hackensack Meridian Health Office of Research Administration, which set up a research committee in the earliest days of the pandemic.
For more information on the ORA, reach out to Cheryl Fittizzi, vice president of Research and Regulatory Affairs, at email@example.com.