Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT05135650
Eligibility Criteria:
Inclusion Criteria:
* Patients (or legally authorized representative if applicable) must be capable of understanding and providing a written informed consent
* Patients must be at least 18 years of age, of any gender, race, or ethnicity
* Patients must be undergoing HCT (any donor or stem cell source including autologous or cord blood)
* History of prior transplants are permitted
* History of COVID-19, history of vaccination for SARS-CoV-2, positive polymerase chain reaction (PCR) of a respiratory specimen for SARS-CoV-2 as long as it is not within four weeks from conditioning, or seropositivity for SARS-CoV-2 are permitted
* History of SARS-CoV-2 infection or vaccination of the donor are permitted.
* Post-enrollment vaccination is anticipated and permitted
* Administration of intravenous immunoglobulin therapy (IVIG) before or during the study is permitted
Exclusion Criteria:
* Signs or symptoms of uncontrolled, active infection
* Positive PCR result for SARS-CoV-2 within four weeks of scheduled conditioning
* Pregnant or breastfeeding (this population is generally not cleared for transplant)
* Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart
* Previous anaphylaxis or severe hypersensitivity reaction, including angioedema, to a mAb
* Previous reaction to a mAb that required medical attention
* Participants of other clinical studies that preclude the use of other investigational compounds
* Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol or unlikely to survive to the end of study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05135650
Study Brief:
Protocol Section:
NCT05135650