Evidence map›Paper›PMID 37460756›Full record

Trial reportNature medicine2023

SARS-CoV-2-specific T cell therapy for severe COVID-19: a randomized phase 1/2 trial.

Anastasia Papadopoulou, George Karavalakis, Efthymia Papadopoulou, Aliki Xochelli, Zoi Bousiou, Anastasios Vogiatzoglou, Penelope-Georgia Papayanni, Aphrodite Georgakopoulou, Maria Giannaki, Fani Stavridou and 33 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
6.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Adoptive T-cell therapy for virus-associated diseases.Clinical microbiology reviews · 2025
    Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. A novel platform for engineered AAV-based vaccines.Molecular therapy. Methods & clinical development · 2025
    Article
  14. Virus-Specific T-Cell Therapy for the Management of Viral Infections in the Immunocompromised.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2025
    Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

43 authors at 7 institutions in 2 countries.

Anastasia PapadopoulouHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.ORCID http://orcid.org/0000-0001-5385-8738
George Karavalakis *Hematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Efthymia Papadopoulou *Department of Respiratory Medicine, George Papanikolaou Hospital, Thessaloniki, Greece.ORCID http://orcid.org/0000-0002-2415-0842
Aliki XochelliDepartment of Immunology, National Peripheral Histocompatibility Center, Hippokration General Hospital, Thessaloniki, Greece.
Zoi BousiouHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Anastasios VogiatzoglouDepartment of Respiratory Medicine, George Papanikolaou Hospital, Thessaloniki, Greece.
Penelope-Georgia PapayanniHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Aphrodite GeorgakopoulouHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Maria GiannakiHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Fani StavridouHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Ioanna VallianouHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Maria KammenouHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Evangelia VarsamoudiHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Vasiliki PapadimitriouHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Chrysavgi Giannaki'A' Intensive Care Unit, George Papanikolaou Hospital, Thessaloniki, Greece.
Maria Sileli'B' Intensive Care Unit, George Papanikolaou Hospital, Thessaloniki, Greece.
Zoi StergioudaDepartment of Anesthesiology, George Papanikolaou Hospital, Thessaloniki, Greece.
Garyfallia StefanouECONCARE LP, Athens, Greece.
Georgia KourlabaDepartment of Nursing, University of Peloponnese, Tripolis, Greece.
George GounelasECONCARE LP, Athens, Greece.
Maria TriantafyllidouHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Eleni SiotouHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Antonia KaraglaniEuromedica Arogi Rehabilitation Center, Thessaloniki, Greece.
Eleni ZotouHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.ORCID http://orcid.org/0009-0008-7113-378X
Georgia ChatzikaDepartment of Immunology, National Peripheral Histocompatibility Center, Hippokration General Hospital, Thessaloniki, Greece.
Anna BouklaDepartment of Immunology, National Peripheral Histocompatibility Center, Hippokration General Hospital, Thessaloniki, Greece.
Apostolia PapalexandriHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Maria-Georgia KoutraHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Dimitra ApostolouDepartment of Respiratory Failure, George Papanikolaou Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Georgia PitsiouDepartment of Respiratory Failure, George Papanikolaou Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Petros Morfesis1st Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Michalis Doumas2nd Propedeutic Department of Internal Medicine, Hippokrateio Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Theodoros KarampatakisDepartment of Microbiology, George Papanikolaou Hospital, Thessaloniki, Greece.
Nikolaos Kapravelos'B' Intensive Care Unit, George Papanikolaou Hospital, Thessaloniki, Greece.
Militsa Bitzani'A' Intensive Care Unit, George Papanikolaou Hospital, Thessaloniki, Greece.
Maria TheodorakopoulouNational and Kapodistrian University of Athens, Evaggelismos General Hospital, Athens, Greece.
Eva SerasliDepartment of Respiratory Medicine, George Papanikolaou Hospital, Thessaloniki, Greece.
Grigorios GeorgolopoulosHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.ORCID http://orcid.org/0000-0002-9906-4797
Ioanna SakellariHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.
Asimina FylaktouDepartment of Immunology, National Peripheral Histocompatibility Center, Hippokration General Hospital, Thessaloniki, Greece.
Stavros TryfonDepartment of Respiratory Medicine, George Papanikolaou Hospital, Thessaloniki, Greece.ORCID http://orcid.org/0000-0001-5102-0480
Achilles AnagnostopoulosHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece.ORCID http://orcid.org/0000-0003-4384-9031
Evangelia YannakiHematopoietic Cell Transplantation Unit, Department of Hematology Gene and Cell Therapy Center, George Papanikolaou Hospital, Thessaloniki, Greece. eyannaki@u.washington.edu.ORCID http://orcid.org/0000-0002-9849-1279
G. Papanikolaou General Hospital · GRAristotle University of Thessaloniki · GRHippocration General Hospital · GREuromedica · GRNational and Kapodistrian University of Athens · GRUniversity of Peloponnese · GRUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite advances, few therapeutics have shown efficacy in severe coronavirus disease 2019 (COVID-19). In a different context, virus-specific T cells have proven safe and effective. We conducted a randomized (2:1), open-label, phase 1/2 trial to evaluate the safety and efficacy of off-the-shelf, partially human leukocyte antigen (HLA)-matched, convalescent donor-derived severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific T cells (CoV-2-STs) in combination with standard of care (SoC) in patients with severe COVID-19 compared to SoC during Delta variant predominance. After a dose-escalated phase 1 safety study, 90 participants were randomized to receive CoV-2-ST+SoC (n = 60) or SoC only (n = 30). The co-primary objectives of the study were the composite of time to recovery and 30-d recovery rate and the in vivo expansion of CoV-2-STs in patients receiving CoV-2-ST+SoC over SoC. The key secondary objective was survival on day 60. CoV-2-ST+SoC treatment was safe and well tolerated. The study met the primary composite endpoint (CoV-2-ST+SoC versus SoC: recovery rate 65% versus 38%, P = 0.017; median recovery time 11 d versus not reached, P = 0.052, respectively; rate ratio for recovery 1.71 (95% confidence interval 1.03-2.83, P = 0.036)) and the co-primary objective of significant CoV-2-ST expansion compared to SοC (CoV-2-ST+SoC versus SoC, P = 0.047). Overall, in hospitalized patients with severe COVID-19, adoptive immunotherapy with CoV-2-STs was feasible and safe. Larger trials are needed to strengthen the preliminary evidence of clinical benefit in severe COVID-19. EudraCT identifier: 2021-001022-22 .

Indexed as

COVID-19Cell- and Tissue-Based TherapyHumansImmunotherapy, AdoptiveSARS-CoV-2Treatment Outcome

Identifiers

PMID37460756
OpenAlexW4384522341

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.