Ribavirin aerosol in hospitalized adults with respiratory distress and COVID‐19: An open‐label trial. Issue 1 (3rd November 2022)

• Record Type: Journal Article
• Authors: Poulakou, Garyfallia; Barakat, Maxime; Israel, Robert J.; Bacci, Marcelo R.
• Other Names: Abril Juan Francisco Moreno Hoyos investigator.; Álvarez Samuel Navarro investigator.; Fonseca Fernando Luiz Affonso investigator.; Kainis Ilias investigator.; Kalomoiri Smaragdi investigator.; Leontis Konstantinos investigator.; Metallidis Symeon investigator.; Panagopoulos Periklis investigator.; Papastamopoulos Vasileios investigator.; Ragognete Henrique Gitti investigator.; Ramacciotti Eduardo investigator.; Rapti Vasiliki investigator.; Sakka Vissaria investigator.; Syrigos Konstantinos N. investigator.; Tsoukalas George investigator.; Xynogalas Ioannis investigator.
• Is Part Of: Clinical and translational science. Volume 16:Issue 1(2023)
• Page Start: 165
• Page End: 174
• Publication Date: 2022-11-03
• Subjects: Medicine, Experimental -- Periodicals; Medical innovations -- Periodicals; 616.027
• DOI: 10.1111/cts.13436
• Languages: English
• ISSNs: 1752-8054

Abstract

Abstract: There is an unmet medical need for effective treatments for hospitalized patients with coronavirus disease 2019 (COVID‐19). Ribavirin is a broad‐spectrum antiviral with demonstrated in vitro activity against multiple viruses, including severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2). This trial evaluated the potential of ribavirin inhalation solution (ribavirin aerosol) to reduce COVID‐19 disease severity in adults with confirmed SARS‐CoV‐2 infection and a diagnosis of respiratory distress. This phase I, multicenter, open‐label, nonrandomized trial was conducted from February 2021 through August 2021. Patients received ribavirin aerosol (100 mg/ml for 30 min or 50 mg/ml for 60 min) twice daily for up to 6 days. The primary end point was change from baseline in clinical status severity, rated on a 7‐point scale (1 [death]; 7 [not hospitalized; no limitations on activities]), at day 7 (or end‐of‐treatment/early termination) and day 30 (follow‐up). Fifty‐one patients were treated with ribavirin aerosol (mean age, 51.5 years; 78.4% men); mean number of doses was 9.7 (range, 1–12). Improvement of ≥1 level in clinical status severity was observed in 31.4% (16/51) and 78.4% (40/51) of patients at end‐of‐treatment and day 30, respectively. Of 21 patients who required a ventilator, 16 (76.2%) were able to discontinue ventilator use. Five patients (9.8%) died between end‐of‐treatment and day 30. Three patients (5.9%) discontinued study treatment due to adverse events. No deaths were considered related to study treatment. These data provide preliminary evidence that ribavirin aerosol may be an efficacious treatment for respiratory distress in adults with COVID‐19.