A Clinical Trial to Evaluate the Safety of agenT-797 in COVID-19 Participants With ARDS (NCT04582201) | Clinical Trial Compass
CompletedPhase 1
A Clinical Trial to Evaluate the Safety of agenT-797 in COVID-19 Participants With ARDS
United States20 participantsStarted 2020-09-21
Plain-language summary
A Phase 1 study of agenT-797 to treat moderate to severe acute respiratory syndrome in Coronavirus disease 2019 (COVID-19) participants.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Voluntarily agree to participate and ability to provide informed consent or have duly appointed health care proxy with the authority to consent.
* Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by polymerase chain reaction test or equivalent approved test.
* Inpatient hospitalization.
* Evidence of SARS-CoV-2 infection with the diagnosis of moderate to severe ARDS per Berlin definition, no more than 2 weeks prior to study enrollment.
* Participants, or duly appointed health care proxy with the authority to consent, must consent to placement of a central venous access line for the administration of agenT-797.
Exclusion Criteria:
* Currently participating and receiving study therapy of an investigational agent that is not registered for any other indication. Note: Participants may receive the standard of care for SARS-CoV-2 infection as per institutional practices.
* Presence of comorbidities limiting expected survival of \<1 month.
* Any comorbidity which in the opinion of the investigator may preclude/confound study required safety and efficacy assessments.
* Clinically significant cardiomyopathy.
* Receipt of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to first dose of study treatment.
* Known hypersensitivity to natural killer cells or their preservation solution.
* Active systemic bacterial or fungal infection or viral co-infection.
* Legally i…
What they're measuring
1
Number of Participants with Treatment-emergent Adverse Events
Timeframe: Baseline through Month 6
2
Number of Participants with Dose-limiting Toxicities