A trial to test the safety and efficacy of a new drug (human immune cells against COVID-19, administered intravenously) for patients with COVID-19 in need of treatment or at risk for severe COVID-19

Phase 1

• 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; MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000417-16-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-01
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 51

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
enrollment
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
d. Receipt of an autologous transplant within the last 5 years
e. Receipt of an allogeneic transplant within the last 5 years or ongoing immunosuppression OR
6. WHO score Score 5
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

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
9. Any other Steroids = 1mg/kg Prednisolon-equivalent/kg BW, besides 6mg Dexamethasone i.v. or p.o. 1x/d as SoC for COVID-19
10. Therapeutic donor lymphocyte infusion (DLI) less than 100 days prior to IMP infusion
11. Known hypersensitivity to iron dextran
12. Known pre-existing human anti-mouse antibodies (HAMAs)
13. Contraindication against mandatory protocol-inherent comedication(s): antihistamine and/or
acetaminophen
14. Pregnant or breast feeding
15. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator's judgment, precludes the subject’s safe participation in and completion of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified