NCT04762186: ACT-COVID-19

Viable Human SARS-CoV-2 Specific T Cell Transfer in Patients at Risk for Severe COVID-19

Terminated Phase 1 Last updated 15 September 2022

What this trial tests

Phase 1 trial testing human SARS-CoV 2 specific T lymphocytes in Moderate COVID-19-infection in 1 participant. Terminated before completion.

Timeline

8 December 2021

Primary endpoint
3 August 2022

3 August 2022

Quick facts

Lead sponsor	Universitätsklinikum Köln
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	8 December 2021
Primary completion	3 August 2022
Estimated completion	3 August 2022
Sites	1 location across Germany

Drugs / interventions tested

• human SARS-CoV 2 specific T lymphocytes — full drug profile →

Conditions studied

• Moderate COVID-19-infection — all drugs for Moderate COVID-19-infection →

Sponsor

Universitätsklinikum Köln — full company profile →

Who can join

Adults 18 to 99, any sex, with Moderate COVID-19-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC

Publications & conference data

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

1. Regulatory T Cells as Predictors of Clinical Course in Hospitalised COVID-19 Patients.
   Caldrer S, Mazzi C, Bernardi M, Prato M, et al · · 2021 · cited 30× · PMID 34925369 · DOI 10.3389/fimmu.2021.789735
2. 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
3. Pathogen-specific T Cells: Targeting Old Enemies and New Invaders in Transplantation and Beyond.
   Papadopoulou A, Alvanou M, Karavalakis G, Tzannou I, et al · · 2023 · cited 11× · PMID 36698615 · DOI 10.1097/hs9.0000000000000809
4. An outlook on antigen-specific adoptive immunotherapy for viral infections with a focus on COVID-19.
   Monzavi SM, Naderi M, Ahmadbeigi N, Kajbafzadeh AM, et al · · 2021 · cited 9× · PMID 34217004 · DOI 10.1016/j.cellimm.2021.104398
5. Effective virus-specific T-cell therapy for high-risk SARS-CoV-2 infections in hematopoietic stem cell transplant recipients: initial case studies and literature review.
   Gopcsa L, Réti M, Andrikovics H, Bobek I, et al · · 2024 · cited 7× · PMID 37414968 · DOI 10.1007/s11357-023-00858-7
6. Rapid Manufacturing of Highly Cytotoxic Clinical-Grade SARS-CoV-2-specific T Cell Products Covering SARS-CoV-2 and Its Variants for Adoptive T Cell Therapy.
   Bonifacius A, Tischer-Zimmermann S, Santamorena MM, Mausberg P, et al · · 2022 · cited 6× · PMID 35480981 · DOI 10.3389/fbioe.2022.867042
7. Antigen-Specific T Cells and SARS-CoV-2 Infection: Current Approaches and Future Possibilities.
   Nova Z, Zemanek T, Botek N. · · 2022 · cited 1× · PMID 36499448 · DOI 10.3390/ijms232315122
8. An overview of the recent findings of cell-based therapies for the treatment and management of COVID-19.
   Ghaffari S, Kazerooni H, Salehi-Najafabadi A. · · 2021 · cited 1× · PMID 34634685 · DOI 10.1016/j.intimp.2021.108226