Maraviroc treatment for hospitalized participants with non-severe COVID-19 at risk of progression: a randomized, proof-of-concept clinical trial

Abstract

Background: Therapeutic options for hospitalized people with COVID-19 remain limited, especially for people with non-severe COVID-19 at risk of progression. The anti-inflammatory role of maraviroc, a CCR5 antagonists, makes it a good candidate for therapeutic strategies for COVID-19.

Methods: This was a proof-of-concept, phase II, parallel, open label clinical trial, to evaluate the safety and efficacy of maraviroc (300 mg, bid), CCR5 antagonist, combined with standard of care (SoC) treatment compared to SoC alone during 14 days, in hospitalized people with mild COVID-19 with pneumonia and ambient air oxygen saturation >94 %. Demographical, clinical, and analytical data were assayed at day 0, 7, 14 and 28.

Results: Thirty-three participants were included, 17 in the control and 16 in the maraviroc group. The proportion of participants who experienced COVID-19 progression was 2.8 times higher in the control group than in the maraviroc group, with three participants admitted in intensive care unit versus none in the maraviroc group. The only variable associated with the time to severe COVID-19 progression was maraviroc treatment. The median time on oxygen therapy was 11 days in the control group, while the two participants in the maraviroc group had oxygen therapy for one and four days. Grade 3-4 events were only present in the control group. Maraviroc treatment was associated with a better neutrophil/lymphocyte ratio and lactate dehydrogenase, IL-6 and TNF-α levels at day 7.

Conclusions: We observed a beneficial role of maraviroc in hospitalized participants with mild COVID-19 at risk of progression at admission.

Keywords: CCR5; COVID-19; IL-6 and TNF-α; Maraviroc; Neutrophil/lymphocyte ratio.