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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT04742595
Eligibility Criteria:
Inclusion criteria:
Immunocompromised patients with hematological malignances and diagnosis of COVID-19 \> 3 weeks prior to study entry, treated with at least one SOC therapy (i.e., remdesivir, monoclonal antibody \[bebtelovimab or newer one\], paxlovid, molnupiravir, corticosteroids, other EUA or FDA-approved therapies) with progression of symptoms in the following 14 days after treatment started, of at least 1 category on the 8 ordinal category on the 8 ordinal category WHO scale, or CT chest/CXR shows progression of pneumonia or increase oxygen requirements of at least 2 liters from baseline. Patients should not show signs of improvement before enrollment.
* World health organization (WHO) scale:
1. Not hospitalized and no COVID-19 related symptoms;
2. Not hospitalized, with COVID-19 related symptoms;
3. Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care (used if hospitalization was extended for infection-control or other nonmedical reasons);
4. Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related to COVID-19);
5. Hospitalized, requiring any supplemental oxygen by nasal cannula;
6. Hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices;
7. Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and
8. Death.
Immunocompromised patient with hematological malignances is defined as:
* Recipients of an allogeneic stem cell transplantation or other form of cell therapy, for example CAR T-cell therapy
* Patients with hematological malignancies who have been in MRD-negative CR for less than 3 years from the completion of their last treatment.
* Patients with hematological malignancies who have been in MRD-negative CR for more than 3 years from the completion of their last therapy and have a peripheral blood CD4 count \<200x109cells/liter
* Patients with hematological malignances who are not in MRD-negative CR and are not expected to require anticancer treatment for at least 28 days after the CTLs infusion.
English and non-English speaking patients. Written informed consent and/or signed assent from patient, parent or guardian. Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study.
Willingness to comply with the study protocol requirements.
Exclusion criteria:
* Patients receiving systemic steroids at time of enrollment (physiological substitutive therapy s allowed), or who have received ATG --within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment.
* Patients with other infections other than COVID-19
* Active acute or chronic GVHD.
* Patients receiving immunosuppressive therapy
* Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04742595
Study Brief:
Protocol Section:
NCT04742595