Trials Sponsors Conditions Drugs Pricing

Conditions

Moderate COVID-19-infection

Keywords

COVID-19T-CellSARS-CoV-2InfusionAdoptiveAllogeneic

Outcome Measures

Primary Outcomes (1)

Phase I: Dose-limiting toxicities
Dose-limiting toxicities until Day 28 after infusion of SARS-CoV-2- specific T cells
28 days

Secondary Outcomes (7)

Phase I: Safety
3 Month
Phase I: Acute graft- vs. -host disease
100 days after enrollment
Phase I: Clinical status
100 days after enrollment
Phase I: Hospitalization
100 days after enrollment
Phase I: SARS-CoV-2 PCR positivity
100 days after enrollment
+2 more secondary outcomes

Study Arms (1)

Dose escalation

EXPERIMENTAL

SARS CoV-2 infected participants will receive a single infusion over 15 to 30 minutes

Drug: human SARS-CoV 2 specific T lymphocytes

Interventions

human SARS-CoV 2 specific T lymphocytesDrug

In dose level one, SARS-CoV-2 infected patients will receive 1,000 viable human SARS CoV-2 specific T lymphocytes per kg BW. In dose level two SARS-CoV-2 infected patients will receive 5,000 viable human SARS CoV-2 specific T lymphocytes per kg BW. In parallel, all patients will receive the current SoC treatment for COVID-19.

Dose escalation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 years or above
Written informed consent from the trial subject has been obtained

Sponsors & Collaborators

ZKS Köln
Othercollaborator
Hannover Medical School
Othercollaborator
Universitätsklinikum Köln

Study Sites (1)

Department I for Internal Medicine University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

Philipp Köhler, Dr.
Department I for Internal Medicine University Hospital of Cologne
PRINCIPAL INVESTIGATOR

Enrollment

1 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Masking Details: During the dose-escalation phase, the study participants and the study team are aware of the treatment as this is an open label trial.
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 21, 2021

Study Start

December 8, 2021

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Dose escalation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Dose escalation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations