Status:
COMPLETED
Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19
Lead Sponsor:
Coeptis Therapeutics
Collaborating Sponsors:
Fred Hutchinson Cancer Center
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This study is being done to determine the highest tolerated dose of an investigational cell therapy called DVX201 in patients hospitalized with COVID-19. DVX201 is an allogeneic NK (natural killer) ce...
Eligibility Criteria
Inclusion
- Be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
- Be between 18 and 80 years of age and weigh at least 40 kg, inclusive, at time of informed consent
- Be confirmed positive for COVID-19 (SARS-CoV-2) infection as determined by validated clinical PCR assay or by a hospital validated serological test within 7 days of consent
- Symptomatic onset within 7 days of signing consent
- Require hospitalization and meet the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scans)
- Able to maintain a SpO2 ≥ 93% at rest. Supplemental oxygen to a maximum 4L by low flow O2-delivery is allowed, but not required
- Meet 2 out of the 3 following criteria:
- i. IL-6 \< 150 pg/mL ii. CRP \< 100 mg/L (10 mg/dL) iii. Ferritin \< 1000 ng/mL
- Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study and for a minimum of 90 days after study treatment
Exclusion
- Weight less than 40 kg
- Be ventilator dependent or be diagnosed with ARDS or multi-system organ failure
- Have elevated oxygen requirement exceeding 4L oxygen by nasal cannula
- Expected intubation within 24 hours per investigators assessment
- Expected discharge from hospital within 72 hours of planned DVX201 date of infusion
- Have a known hypersensitivity to constituents of DVX201, such as DMSO or atinhistamine medications
- Have a history of symptomatic pulmonary or chronic pulmonary disease or severe asthma on chronic therapy for treatment
- Have a history of baseline requirement of supplemental oxygen prior to COVID-19 diagnosis
- Active autoimmune disorder or other medical condition requiring systemic immunosuppressive therapy (including steroids at \> 5 mg prednisone or equivalent daily)
- Be pregnant or breast-feeding
- Have inadequate organ function as defined by:
- Acute or chronic kidney injury requiring intermittent or continuous venovenous hemodialysis or estimated GFR of \< 60 mL/min/1.73 m2
- Abnormal liver function defined by AST (aspartate aminotransferase), ALT (alanine aminotransferase) or alkaline phosphatase ≥ 5 times the upper limit of normal
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04900454
Start Date
August 1 2021
End Date
July 1 2022
Last Update
April 8 2024
Active Locations (1)
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1
Fred Hutch/University of Washington Medical Center
Seattle, Washington, United States, 98109