An expanded access record providing Convalescent Plasma in COVID-19, sponsored by Hackensack Meridian Health. No longer available at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-12.
Sponsored by Hackensack Meridian Health · Expanded access
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.
This expanded access program will provide access to investigational convalescent plasma for patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. Following enrollment on the protocol and provision of informed consent, patients will be transfused with approximately 200-500 mL of ABO compatible convalescent plasma obtained from individuals who have recovered from documented infection with SARS-CoV-2 and who have been found to have high anti-SARS-CoV2 titers. Safety information collected will include serious adverse events judged to be related to the administration of convalescent plasma. Other information to be collected retrospectively will include patient demographics, resource utilization (total length of stay, days in ICU, days intubated, and survival to discharge from the facility.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
Browse COVID-19 studies →Hackensack Meridian Health is the lead sponsor of 111 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 11 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Severe COVID-19 is defined by one or more of the following:
Life-threatening COVID-19 is defined as one or more of the following:
Fresh or frozen plasma will be infused one time to patients with COVID-19 infection
Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.
No contact was published for this record. The registry link below has the sponsor’s details.
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Hackensack Meridian Health