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COVID-19 PneumoniaPhase 1NCT04900454

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

A Phase 1 study testing DVX201 in people with COVID-19 Pneumonia, run by Coeptis Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) cell therapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
COVID-19 Pneumonia
What is being tested?
DVX201
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Aug 2021to 1 Jul 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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:
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Medical Center

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase 1 Study of DVX201, an Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19

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.

Being tested
DVX201
Keywords
NK cells, Cell therapy, Allogeneic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DVX201Biological

    Single infusion of DVX201, an allogeneic NK cell therapy derived from CD34+ hematopoietic stem cells

Study groups in NCT04900454
Study groupRoleWhat they receive
DVX201 infusionExperimentalSubjects will enroll and the MTD and/or the recommended phase 2 dose of DVX201 will be determined utilizing a modified "3+3" enrollment schema. This study will enroll a minimum 3 subjects who each receive a single dose of DVX201 and who are evaluable for toxicities at each dose level. Depending on the occurrence of DLTs and the number of dose levels evaluated, additional subjects may be enrolled (approximately 3-15 additional subjects). All subjects will be followed for 28 days post infusion of DVX201.
Receives: Biological: DVX201

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities (DLT)

    DLTs defined as grade 3 or greater infusion related reactions within 24 hours and any treatment emergent toxicity grade 3 or greater within 7 days apart from known complications of COVID-19

    Measured: 7 days

Secondary outcomes (5)

  1. reduction/clearance of viral load/viral shedding

    time in days to clearance of virus

    Measured: through study completion, an average of 28 days post cell infusion

  2. Oxygen requirements

    Time in days on supplemental oxygen and time in days to resolution of hypoxia

    Measured: through study completion, an average of 28 days post cell infusion

  3. Disease progression

    Incidence of disease progression to ICU admission and/or ventilatory support

    Measured: through study completion, an average of 28 days post cell infusion

  4. CRS

    Incidence of cytokine release syndrome requiring clinical intervention

    Measured: through study completion, an average of 28 days post cell infusion

  5. hospital discharge

    Time in days post infusion of DVX201 to hospital discharge

    Measured: through study completion, an average of 28 days post cell infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2021
  2. Study start1 Aug 2021
  3. Primary completion7 Jun 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an, open-label, non-randomized Phase 1 dose-finding study of DVX201 in patients hospitalized with COVID-19. Subjects will enroll and the MTD and/or the RP2D of DVX201 will be determined utilizing a modified "3+3" enrollment schema.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04900454
Sponsor's protocol ID
DVX201-COV-01
Other IDs
RG1121470
Status last verified
Mar 2024
First submitted
20 May 2021
Last updated
8 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DVX201 in people with COVID-19 Pneumonia, run by Coeptis Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (DLT) (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04900454.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.

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