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CCR1 antagonist treatment in patients hospitalized with COVID-19

Organizational Data

DRKS-ID:
DRKS00024465
Recruitment Status:
Recruiting stopped (after recruiting started)
Date of registration in DRKS:
2021-11-04
Last update in DRKS:
2023-04-25
Registration type:
Prospective

Acronym/abbreviation of the study

CATCOVID

URL of the study

No Entry

Brief summary in lay language

Treatment of the excessive inflammatory response in patients with COVID-19 using an inhibitor of the chemokine receptor CCR1. Inhibition of CCR1 is expected to block a specific activation pathway of the excessive inflammation and thereby mitigate the severity of the disease course.

Brief summary in scientific language

This clinical phase II trial, CATCOVID, will evaluate a novel treatment strategy based on the inhibition of the C-C chemokine receptor 1 (CCR1). This chemokine receptor was found to be highly expressed in COVID-19 patients with severe to critical disease. The CCR1 antagonist may reduce hyperinflammation and subsequent tissue damage resulting in ARDS, multi-organ failure, and death.

Health condition or problem studied

Free text:
COVID-19 - SARS-CoV-2 infection
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
CCR-1 inhibitor BAY86-5277, per os, 4x600mg / d (q6h) for 10d
Arm 2:
Placebo = Diluent, active macrogol 400 based solution, d (q6h) for 10 d

Endpoints

Primary outcome:
ventilator-free days at day 28
Secondary outcome:
WHO clinical progression scale, Severity of gas exchange impairment (paO2/FiO2), Duration in days of supplemental oxygen, Duration in days of MV, ICU-free days, Duration in days of hospitalization, SOFA at Day 1, 10, 28, Mortality

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Placebo
Phase:
II
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Investigator/therapist
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting stopped (after recruiting started)
Reason if recruiting stopped or withdrawn:
No further recruitment possible due to course of pandemic

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center BG Klinikum Unfallkrankenhaus Berlin gGmbH, Klink für Anästhesiologie, Intensiv- u. Schmerzmedizin, Berlin
  • University medical center Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie Würzburg
  • University medical center Charite, Medizinische Klinik m.S. Infektiologie und Pneumologie Berlin
  • University medical center Zentrum f. Innere Medizin II, Abt. Tropenmedizin und Infektionskrankheiten u. Sektion Nephrologie Rostock
  • University medical center Klinik und Poliklinik für Anästhesiologie und Intensivtherapie Leipzig

Recruitment period and number of participants

Planned study start date:
2021-12-01
Actual study start date:
2021-12-22
Planned study completion date:
2024-06-30
Actual Study Completion Date:
2023-03-20
Target Sample Size:
208
Final Sample Size:
5

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Positive laboratory-confirmed SARS-CoV-2 PCR test, WHO clinical progression scale 5-6, Onset of COVID-19 symptoms < 10 days before randomization, Age ≥ 18 years, Male or non-pregnant/non-breast-feeding female, Subject understands the clinical trial and signed the informed consent form

Exclusion Criteria

Patients has a chance of survival < 48 hours at time of randomization, Participation in another interventional clinical trial, Specific immunomodulatory treatment for COVID-19 according to the german S3 living guideline on therapy for patient hospitalized for COVID-19 longer than 72 hours before randomization, Other indications for systemic or inhaled glucocorticoid treatment, Immunosuppressive medication within the last 30 days before randomization, Immunosuppressive disease, Chronic inflammatory airways disease (e.g., COPD), Renal failure requiring dialysis, Chronic liver failure (Child-Pugh class C), Acute (or acute on chronic) liver failure Chronic heart failure NYHA III/IV, Acute right heart failure, Clear evidence of active tuberculosis, bacterial, fungal, viral, or other infection (besides SARSCoV-2), Current or regular treatment with Chloramphenicol, Current or regular treatment with Nefazodone, Current or regular treatment with Cimetidin, Current or regular treatment with macrolide antibiotics, Current or regular treatment with azole antimycotics, Treatment with Phenytoin, Person is placed in an institution based on an official or judicial order, Person who is dependent on the Sponsor, Principal Investigators, or the study site

Addresses

Primary Sponsor

Charité Campus Benjamin Franklin, Medizinische Klinik für Kardiologie
Prof. Ulf Landmesser
Hindenburgdamm 30
12200 Berlin
Germany
Telephone:
+4930450513702
Fax:
No Entry
Contact per E-Mail
URL:
http://www.charite.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Berlin Institute of Health at Charité, Digital Health Center
Prof. Dr. Roland Eils
Kapelle-Ufer 2
10117 Berlin
Germany
Telephone:
+49-30-450 543 084
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Medizinische Klinik für Kardiologie
Prof. Dr. Ulf Landmesser
Hindenburgdamm 30
12200 Berlin
Germany
Telephone:
+49 30 450 513 702
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Berlin Institute of Health at Charité, Digital Health Center
Prof. Dr. Roland Eils
Kapelle-Ufer 2
10117 Berlin
Germany
Telephone:
+49-30-450 543 084
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Bildung und Forschung Dienstsitz Berlin
Friedrichstraße 130 B
10117 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bmbf.de

Ethics Committee

Address Ethics Committee

Geschäftsstelle der Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig c/o Zentrale Poststelle
Liebigstraße 18
04103 Leipzig
Germany
Telephone:
+49-341-9715490
Fax:
+49-341-9715499
Contact per E-Mail
URL:
http://home.uni-leipzig.de/ethik

Vote of leading Ethics Committee

Date of ethics committee application:
2021-06-14
Ethics committee number:
315/21-ff
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-10-29

Other Address Ethics Committee

Ethikkommission an der Medizinischen Fakultät der Universität Rostock im Institut für Rechtsmedizin
St.-Georg-Str. 108
18055 Rostock
Germany
Telephone:
+49-381-4949904
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of the Ethics Committee

Vote of the Ethics Committee:
Approved
Date of the vote:
2022-03-17

Further identification numbers

Other primary registry ID:
20016611 - Zentrales Studienregister (ZSR) der Charité
EudraCT Number:
2021-000613-16
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry