TCB008 in Patients With COVID-19

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase II safety and tolerability study of expanded gamma delta T cell lymphocytes (TCB008) in patients diagnosed with COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TC Biopharm

Criteria

Inclusion Criteria:

1. Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF);

• willingness and capability to complete all the study procedures

2. Age 18-65 years (inclusive) at the time of signing ICF

3. Any gender

4. Patients with a positive diagnosis of COVID-19 either identified in the community as at risk of progression of disease or

• already hospitalized with new changes on CXR or CT scan compatible with COVID19, or

• patients requiring supplemental oxygen, but for whom dexamethasone is not yet indicated according to current standard of care recommendations.

The product would be indicated for patients categorized as per the WHO ordinal scale 2,3 or 4: i.e., ambulatory (or community identified) patients with limitations of activity, judged as at risk for progression of disease, as well as hospitalized patients not yet requiring oxygen therapy or receiving non-invasive low flow oxygen therapy, which does not yet indicate the need to commence dexamethasone therapy.

Exclusion Criteria:

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