EUCTR2021-000417-16-DE
Active, not recruiting
Phase 1
A Phase I / randomized Phase II trial to analyse safety and efficacy of human SARS-CoV 2 specific T lymphocyte transfer in patients with COVID-19 in need of treatment or at risk of severe COVID-19 - ACT-COVID19
niversity of Cologne0 sites51 target enrollmentApril 1, 2021
ConditionsPatients who are tested positive for SARS-CoV-2 by PCR from upper or lower respiratory sites and are at increased risk for developing critical disease presenting with moderate disease-WHO ordinal scale 4 with at least one additional risk factor for disease progression or -WHO ordinal scale 5MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients who are tested positive for SARS-CoV-2 by PCR from upper or lower respiratory sites and are at increased risk for developing critical disease presenting with moderate disease-WHO ordinal scale 4 with at least one additional risk factor for disease progression or -WHO ordinal scale 5
- Sponsor
- niversity of Cologne
- Enrollment
- 51
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For phase I and II
- •1\. Ability to understand the purpose and risks of the study and provide signed and dated informed consent (participants \= 18 years of age)
- •2\. Willing to follow contraception guidelines
- •3\. Tested positive for SARS\-CoV\-2 by PCR \<72 hours prior to inclusion
- •4\. A maximum of 14 days between onset of symptoms and
- •5\. WHO score 4 with at least one additional risk factor for disease progression
- •Acceptable risk factors are:
- •a. Radiographically proven lung infiltrates
- •b. Immunosuppression either by malignant disease or its treatment, or other underlying diseases leading to immunodeficiency or underlying diseases that require treatment resulting in immunosuppression
- •c. Immunosuppressive drugs, including steroids at a prednisolone equivalent of \<1 mg/kg BW. 6mg dexamethasone per os or intravenous 1x/d (SOC) are allowed, but are not considered as inclusion criterion in the sense of immunosuppressive treatment
Exclusion Criteria
- •For phase I and II
- •1\. Participation in any other clinical trial of an experimental agent treatment
- •2\. Active or history of GvHD
- •3\. History of CAR\-T\-Cell Therapy
- •4\. COVID\-19 WHO ordinal scale \=6
- •5\. Anticipated life\-expectancy \<72 hours
- •6\. Expected duration of hospital stay \<72 hours
- •7\. Sepsis\-induced leukopenia or thrombocytopenia (leukocytes \<1000/µl or platelets \<50\.000/µl). If the cytopenias result from underlying hematologic disease or its treatment, this will not be
- •regarded as exclusion criterion.
- •8\. CT pneumonia score \=13, if CT has been performed as SoC
Outcomes
Primary Outcomes
Not specified
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