CCR1 antagonist treatment in patients hospitalized with COVID-19A multi-centric, randomized, double-blind, and placebo-controlled clinical phase II trial

Phase 1

• Conditions: Patients with acute SARS-CoV-2 infection, proven by a positive SARS-CoV-2 PCR test. The health status of the patients at inclusion in the clinical trial is rated 5 - 6 according to the WHO scale (see protocol, CATCOVID_v1.2, 27.09.2021, page 13). Patients are at high risk of severe disease progression with ARDS and/or multiple organ failure, and at high risk of mortality.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000613-16-DE
• Lead Sponsor: Charité – Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-08
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

In order to be eligible to participate in this study, a patient must meet all of the following inclusion
criteria:

1. Age = 18 years
2. Male or non-pregnant*/non-breast-feeding female
3. Subject understands the clinical trial and signed the informed consent form
4. Positive laboratory-confirmed SARS-CoV-2 PCR test
Allergy to dexamethasone
5. WHO clinical progression scale 5-6
6. Onset of COVID-19 symptoms < 10 days before randomization

*negative pregnancy test

See protocol, CATCOVID_v1.2, 27.09.2021: Chapter 7 (Study Population); Subchapter 7.1, page 37f.
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 208
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 208

Exclusion Criteria

Exclusion Criteria:

1. Patient has a chance of survival < 48 hours at time of randomization
2. Participation in another interventional clinical trial
3. Specific immunomodulatory treatment for COVID-19 according to the S3 living guideline for > 72 hours before randomization
4. Other indications for systemic or inhaled glucocorticoid treatment
5. Immunosuppressive medication within the last 30 days before randomization
6. Immunosuppressive disease
7. Chronic inflammatory airways disease (e.g., COPD)
8. Renal failure requiring dialysis
9. Acute (or acute on chronic) liver failure, Chronic liver failure (Child-Pugh class C)
10. Chronic heart failure NYHA III/IV
11. Acute right heart failure
12. Clear evidence of active tuberculosis, bacterial, fungal, viral, or other infection (besides SARS-CoV-2)
13. Current or regular treatment with Chloramphenicol*
14. Current or regular treatment with Nefazodone*
15. Current or regular treatment with Cimetidin*
16. Current or regular treatment with macrolide antibiotics*
17. Current or regular treatment with azole antimycotics*
18. Treatment with Phenytoin**
19. Person is placed in an institution based on an official or judicial order
20. Person who is dependent on the Sponsor, Principal Investigators, or the study site

*Please note that only clinically relevant strong CYP3A4 inhibitors were considered, please note that
protease inhibitors will not be relevant for this study as patients with an immunosuppressive disease
are excluded (see also section 8.1.4).
** Please note that only strong CYP3A4 inducers were considered (see also section 8.1.4)

See protocol, CATCOVID_v1.2, 27.09.2021: Chapter 7 (Study Population); Subchapter 7.1, page 37f.

Study & Design

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