NCT04500418

Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients

Terminated Phase 2 Last updated 29 March 2022

What this trial tests

Phase 2 trial testing Cenicriviroc (CVC) in Covid19 in 45 participants. Terminated before completion.

Timeline

25 August 2020

Primary endpoint
27 July 2021

27 July 2021

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	45
Start date	25 August 2020
Primary completion	27 July 2021
Estimated completion	27 July 2021
Sites	1 location across Germany

Drugs / interventions tested

• Cenicriviroc (CVC) — full drug profile →
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Charite University, Berlin, Germany

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to test Cenicriviroc (CVC) as a means to reduce the severity of the lung disease COVID-19 caused by an infection with SARS-CoV-2. The safety of CVC, when administered to COVID-19 patients, will also be assessed. Furthermore, the clinical trial aims to answer the question of whether patients with pre-existing conditions, who have an increased risk of severe COVID-19 progression, benefit more and particularly from CVC. CVC is an orally available dual inhibitor of the chemokine receptors CCR2 and CCR5, which is expected to reduce (hyper-) inflammation in COVID-19.

The main goal of the study is to determine whether CVC helps increase the number of patients who are symptom-free and not hospitalized after 14 days compared to a placebo. Approximately 66.7% of the patients enrolled in the study will receive CVC and 33.3% will get an optically identical pill (placebo).

Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 8, 15, 22, and 29 and 85. All subjects will undergo a series of clinical, safety, and laboratory assessments. Blood samples and oropharyngeal (OP) swabs will be obtained on Day 1; 3, 5 (while hospitalized); and Day 8, 15 and 29 (if able to return to clinic or still hospitalized). The presence of anti-SARS-CoV-2 antibodies will be determined on Days 29 and 85.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CCL5/CCR5 axis in human diseases and related treatments.
   Zeng Z, Lan T, Wei Y, Wei X. · · 2022 · cited 254× · PMID 34514075 · DOI 10.1016/j.gendis.2021.08.004
2. Overview of SARS-CoV-2 infection in adults living with HIV.
   Ambrosioni J, Blanco JL, Reyes-Urueña JM, Davies MA, et al · · 2021 · cited 159× · PMID 33915101 · DOI 10.1016/s2352-3018(21)00070-9
3. Role of chemokine systems in cancer and inflammatory diseases.
   Li H, Wu M, Zhao X. · · 2022 · cited 85× · PMID 35702353 · DOI 10.1002/mco2.147
4. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
   Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
5. Role of CCL2/CCR2 axis in the pathogenesis of COVID-19 and possible Treatments: All options on the Table.
   Ranjbar M, Rahimi A, Baghernejadan Z, Ghorbani A, et al · · 2022 · cited 48× · PMID 36252475 · DOI 10.1016/j.intimp.2022.109325
6. Type I interferon response in astrocytes promotes brain metastasis by enhancing monocytic myeloid cell recruitment.
   Ma W, Oliveira-Nunes MC, Xu K, Kossenkov A, et al · · 2023 · cited 47× · PMID 37149684 · DOI 10.1038/s41467-023-38252-8
7. A regulatory T cell signature distinguishes the immune landscape of COVID-19 patients from those with other respiratory infections.
   Vick SC, Frutoso M, Mair F, Konecny AJ, et al · · 2021 · cited 46× · PMID 34757794 · DOI 10.1126/sciadv.abj0274
8. COVID-19-Induced Modifications in the Tumor Microenvironment: Do They Affect Cancer Reawakening and Metastatic Relapse?
   Francescangeli F, De Angelis ML, Baiocchi M, Rossi R, et al · · 2020 · cited 29× · PMID 33194755 · DOI 10.3389/fonc.2020.592891