Cell therapy using thymic Treg cells to manage immune response in COVID-19 and ARDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of allogeneic thymic regulatory T cells (thyTreg) in patients experiencing immune hyperactivation due to COVID-19 and acute respiratory distress syndrome (ARDS). The study employs a sequential parallel group design and aims to determine if these specialized Treg cells can help restore immune balance and reduce excessive inflammation. Participants will receive either 5 million or 10 million thyTreg cells, with the goal of improving clinical outcomes and preventing multi-organ failure associated with severe respiratory conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient over 18 to 65 years of age
2. Patient Informed and non-opposed to the research by his medical doctor during hospitalization
3. Patient with clinical, radiological, gasometric and immunological criteria defined as:

   1. Acute respiratory failure secondary to acute lung injury of noncardiogenic cause
   2. Pulmonary abnormalities compatible with bilateral alveoloinsterstitial infiltrates by chest imaging (radiograph or scan)
   3. PaO2/FiO2≤ 300 Presence of at least one of the following markers of inflammation: IL6 \> 40 pg/ml or ferritin \>300 ng/ml or CRP \>3 mg/dl or increasing over the last 24 hours

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Body mass index \>35
3. Patients not expected to survive 48 hours after enrolment based on clinical assessment
4. Patients with an extracorporeal respiratory support
5. Neutropenia (absolute neutrophil count \<1000/uL)
6. Thrombocytopenia (absolute neutrophil count \<50000/uL)
7. Positive serology for HBV, HCV, or HIV at Screening
8. Life expectancy of less than 6 months due to other pathologies
9. History of significant underlying pulmonary disease requiring oxygen therapy prior to inclusion.
10. Patients with a history of autoimmune diseases
11. Patients with a history of hematopoietic neoplasia or oncology disease
12. Patients with a history of hematopoietic or solid organ transplant
13. Patients with a congenital or induced immunodeficiency
14. Patients received thymoglobulin, basiliximab or any anti-T-cell therapies within 6 moths prior to the screening visit
15. Patients received other cell therapy in the last 12 months
16. Patients received intravenous immunoglobulin (IVIg) within 5 moths prior to the screening visit
17. Patients who have participated or is participating in a clinical research study evaluating COVID-19 or ARDS within 30 days prior to the screening visit

Where it's running

• Hospital General Universitario Gregorio Marañon
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Rafael Correa-Rocha, PhD — Hospital General Universitario Gregorio Marañon
• Study coordinator: Marta Martínez-Bonet, PhD
• Email: marta.mbonet@iisgm.com
• Phone: 34 915866455

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.