NCT04900454

Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19

Completed Phase 1 Last updated 8 April 2024

What this trial tests

Phase 1 trial testing DVX201 in COVID-19 Pneumonia in 12 participants. Completed in 1 July 2022.

Timeline

1 August 2021

Primary endpoint
7 June 2022

1 July 2022

Quick facts

Lead sponsor	Coeptis Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 August 2021
Primary completion	7 June 2022
Estimated completion	1 July 2022
Sites	1 location across United States

Drugs / interventions tested

• DVX201 — full drug profile →

Conditions studied

• COVID-19 Pneumonia — all drugs for COVID-19 Pneumonia →

Sponsor

Coeptis Therapeutics — full company profile →

Who can join

Adults 18 to 80, any sex, with COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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) cell therapy. NK cells are a normal part of your immune system that have the ability to identify and kill cells in the body that are infected by viruses such as COVID-19. There is evidence that both NK cell exhaustion and low numbers of NK cell in the blood occur in COVID-19 patients, and this may contribute to worsening of the infection. Therefore, infusion of healthy functional NK cells (like DVX201) may help overcome COVID-19 infection and prevent progression of the disease. This study is being done to look at the safety and tolerability of DVX201 in patients with COVID-19 and to gather information on how COVID-19 responds to treatment with DVX201.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Natural Killer Cells in SARS-CoV-2 Infection: Pathophysiology and Therapeutic Implications.
   Di Vito C, Calcaterra F, Coianiz N, Terzoli S, et al · · 2022 · cited 55× · PMID 35844604 · DOI 10.3389/fimmu.2022.888248
2. Innate and Adaptive Immunity during SARS-CoV-2 Infection: Biomolecular Cellular Markers and Mechanisms.
   Brown B, Ojha V, Fricke I, Al-Sheboul SA, et al · · 2023 · cited 32× · PMID 36851285 · DOI 10.3390/vaccines11020408
3. Glycoprotein Targeted CAR-NK Cells for the Treatment of SARS-CoV-2 Infection.
   Christodoulou I, Rahnama R, Ravich JW, Seo J, et al · · 2021 · cited 23× · PMID 35003077 · DOI 10.3389/fimmu.2021.763460
4. Natural killer cells and their exosomes in viral infections and related therapeutic approaches: where are we?
   Razizadeh MH, Zafarani A, Taghavi-Farahabadi M, Khorramdelazad H, et al · · 2023 · cited 17× · PMID 37749597 · DOI 10.1186/s12964-023-01266-2
5. Exploring the Utility of NK Cells in COVID-19.
   Deng X, Terunuma H, Nieda M. · · 2022 · cited 17× · PMID 35625739 · DOI 10.3390/biomedicines10051002
6. Cellular therapies for the treatment and prevention of SARS-CoV-2 infection.
   Conway SR, Keller MD, Bollard CM. · · 2022 · cited 16× · PMID 35240679 · DOI 10.1182/blood.2021012249
7. Next-generation treatments: Immunotherapy and advanced therapies for COVID-19.
   Arevalo-Romero JA, Chingaté-López SM, Camacho BA, Alméciga-Díaz CJ, et al · · 2024 · cited 13× · PMID 38434363 · DOI 10.1016/j.heliyon.2024.e26423
8. Bracing NK cell based therapy to relegate pulmonary inflammation in COVID-19.
   Jeyaraman M, Muthu S, Bapat A, Jain R, et al · · 2021 · cited 11× · PMID 34312598 · DOI 10.1016/j.heliyon.2021.e07635