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Cenicriviroc for the treatment of COVID-19: first interim results of a randomised, placebo-controlled, investigator-initiated, double-blind phase II trial

Kurth et al., Journal of Global Antimicrobial Resistance, doi:10.1016/j.jgar.2022.12.004, NCT04500418
Mar 2023  
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Mortality -167% Improvement Relative Risk Ventilation -167% Oxygen therapy -500% Recovery -100% Hospitalization time -17% Cenicriviroc  Kurth et al.  LATE TREATMENT  DB RCT Is late treatment with cenicriviroc beneficial for COVID-19? Double-blind RCT 30 patients in Germany (September - December 2020) Higher need for oxygen therapy (p=0.26) and worse recovery (p=0.55), not sig. c19early.org Kurth et al., J. Global Antimicrobial .., Mar 2023 Favorscenicriviroc Favorscontrol 0 0.5 1 1.5 2+
RCT 30 hospitalized COVID-19 patients showing no significant difference in clinical improvement with cenicriviroc (CVC) treatment compared to placebo.
risk of death, 166.7% higher, RR 2.67, p = 1.00, treatment 1 of 18 (5.6%), control 0 of 12 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 166.7% higher, RR 2.67, p = 1.00, treatment 1 of 18 (5.6%), control 0 of 12 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of oxygen therapy, 500.0% higher, RR 6.00, p = 0.26, treatment 3 of 18 (16.7%), control 0 of 12 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of no recovery, 100% higher, OR 2.00, p = 0.55, treatment 17, control 12, inverted to make OR<1 favor treatment, RR approximated with OR.
hospitalization time, 16.7% higher, relative time 1.17, p = 0.42, treatment median 7.0 IQR 5.0 n=17, control median 6.0 IQR 3.4 n=12.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kurth et al., 31 Mar 2023, Double Blind Randomized Controlled Trial, placebo-controlled, Germany, peer-reviewed, median age 61.0, 18 authors, study period 1 September, 2020 - 29 December, 2020, average treatment delay 8.8 days, trial NCT04500418 (history). Contact: kurth@charite.de, frank.tacke@charite.de.
This PaperCenicrivirocAll
Abstract: Journal of Global Antimicrobial Resistance 32 (2023) 44–47 Contents lists available at ScienceDirect Journal of Global Antimicrobial Resistance journal homepage: www.elsevier.com/locate/jgar Short Communication Cenicriviroc for the treatment of COVID-19: first interim results of a randomised, placebo-controlled, investigator-initiated, double-blind phase II trial Florian Kurth a,b,1,∗, Elisa T. Helbig a,1, Lena J. Lippert a,1, Charlotte Thibeault a, Gianluca Barbone c, Marius A. Eckart c, Martin Kluge c, Tobias Puengel c, Münevver Demir c, Robert Röhle d,e, Theresa Keller d, Christoph Ruwwe-Glösenkamp a, Martin Witzenrath a,f, Norbert Suttorp a, Christof von Kalle g, Leif E. Sander a, Christoph Jochum c, Frank Tacke c,∗∗ a Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Infectious Diseases and Respiratory Medicine, Berlin, Germany b Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine and Department of Medicine I, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany c Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Hepatology and Gastroenterology, Berlin, Germany d Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Biometry and Clinical Epidemiology, Berlin, Germany e Berlin Institute of Health at Charité – Universitätsmedizin Berlin, Berlin, Germany f German Centre for Lung Research (DZL), Gießen, Germany g Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Clinical Study Centre (CSC), Berlin, Germany a r t i c l e i n f o Article history: Received 29 November 2021 Revised 2 June 2022 Accepted 12 December 2022 Available online 23 December 2022 Editor by: Prof Marco Falcone Keywords: Cenicriviroc COVID-19 Clinical trial SARS-CoV-2 ARDS a b s t r a c t Objectives: C-C-chemokine receptors (CCRs) are expressed on a variety of immune cells and play an important role in many immune processes, particularly leukocyte migration. Comprehensive preclinical research demonstrated CCR2/CCR5-dependent pathways as pivotal for the pathophysiology of severe COVID19. Here we report human data on use of a chemokine receptor inhibitor in patients with COVID-19. Methods: Interim results of a 2:1 randomised, placebo-controlled, investigator-initiated trial on the CCR2/CCR5-inhibitor Cenicriviroc (CVC) 150 mg BID orally for 28 d in hospitalised patients with moderate to severe COVID-19 are reported. The primary endpoint is the subject’s responder status defined by achieving grade 1 or 2 on the 7-point ordinal scale of clinical improvement on day 15. Results: Of the 30 patients randomised, 18 were assigned to receive CVC and 12 to placebo. Efficient CCR2- and CCR5 inhibition was demonstrated through CCL2 and CCL4 elevation in CVC-treated patients (485% and 80% increase on day 3 compared to the baseline, respectively). In the modified intention-totreat population, 82.4% of patients (14/17) in the CVC group met the primary endpoint, as did 91.7% (11/12) in the placebo group (OR = 0.5, 95% CI = 0.04–3.41). One patient treated with CVC died of progressive acute respiratory distress syndrome, and the remaining had a favourable outcome. Overall, treatment with CVC was well tolerated,..
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Late treatment
is less effective
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