An Experiment to Evaluate the Safety of agenT-797 in COVID-19 Patients With Severe Difficulty Breathing.

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1 Study of AGENT-797 to treat moderate to severe acute respiratory syndrome in COVID-19 patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AgenTus Therapeutics, Inc.; MiNK Therapeutics

Criteria

Inclusion Criteria:

1. Voluntarily agree to participate and ability to provide informed consent or have duly appointed health care proxy with the authority to consent.

2. ≥ 18 years of age.

3. Confirmed diagnosis of SARS-CoV-2 infection by polymerase chain reaction test or equivalent approved test.

4. Inpatient hospitalization.

5. Evidence of SARS-CoV-2 infection with the diagnosis of moderate to severe ARDS per Berlin definition (ARDS 2012), no more than 2 weeks prior to study enrollment.

6. Patients, 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:

1. Currently participating and receiving study therapy of an investigational agent that is not registered for any other indication.

Note: Patients may receive the standard of care for SARS-CoV-2 infection as per institutional practices.

2. Presence of comorbidities limiting expected survival of < 1 month.

3. Any comorbidity which in the opinion of the Investigator may preclude/confound study required safety and efficacy assessments.

4. Clinically significant cardiomyopathy.

5. Receipt of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to first dose of study treatment.

6. Known hypersensitivity to natural killer (NK) cells or their preservation solution.

7. Active systemic bacterial or fungal infection or viral co-infection.

8. Legally incapacitated or has limited legal capacity.

9. Pregnant or lactating women.