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A randomized, placebo-controlled study to evaluate safety and pharmacokinetics of inhaled ribavirin.
Couroux, Peter; Brkovic, Alexandre; Vittitow, Jason L; Israel, Robert J; Pamidi, Chinna; Patel, Jignesh; Barakat, Maxime.
  • Couroux P; Cliantha Research, Mississauga, Ontario, Canada.
  • Brkovic A; Bausch Health, Laval, Quebec, Canada.
  • Vittitow JL; Bausch Health, Bridgewater, New Jersey, USA.
  • Israel RJ; Bausch Health, Bridgewater, New Jersey, USA.
  • Pamidi C; Cliantha Research, Mississauga, Ontario, Canada.
  • Patel J; Cliantha Research, Mississauga, Ontario, Canada.
  • Barakat M; Bausch Health, Laval, Quebec, Canada.
Clin Transl Sci ; 15(9): 2159-2171, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-1891527
ABSTRACT
Ribavirin is an inosine monophosphate dehydrogenase inhibitor. Studies suggest ribavirin aerosol could be a safe and efficacious treatment option in the fight against coronaviruses. However, current treatment is long (12-18 h per day, 3-7 days), limiting clinical utility. A reduction in treatment time would reduce treatment burden. We aimed to evaluate safety and pharmacokinetics (PK) of four, single-dose regimens of ribavirin aerosol in healthy volunteers. Thirty-two subjects were randomized, to four cohorts of aerosolized ribavirin (active) or placebo. Cohort 1 received 50 mg/ml ribavirin/placebo (10 ml total volume); cohort 2, 50 mg/ml ribavirin/placebo (20 ml total volume); cohort 3, 100 mg/ml ribavirin/placebo (10 ml total volume); and cohort 4, 100 mg/ml ribavirin/placebo (20 ml total volume). Intense safety monitoring and PK sampling took place on days 1, 2, 3, and 40. Subjects were (mean ± SD, active vs. placebo) aged 57 ± 4.5 vs. 60 ± 2.5 years; 83% vs. 88% were female; and 75% vs. 50% were Caucasian. Some 12.5% (3/24) and 25% (2/8) experienced at least one treatment-emergent adverse event (TEAE) (two moderate; five mild) in the active and placebo groups, respectively. No clinically significant safety concerns were reported. Mean maximum observed concentration (Cmax ) and area under the curve (AUC) values were higher in cohort 4, whereas cohorts 2 and 3 showed similar PK values. Ribavirin absorption reached Cmax within 2 h across cohorts. Four single-dose regimens of ribavirin aerosol demonstrated systemic exposure with minimal systemic effects. Results support continued clinical development of ribavirin aerosol as a treatment option in patients with coronaviruses.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Ribavirin Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Female / Humans / Male Language: English Journal: Clin Transl Sci Year: 2022 Document Type: Article Affiliation country: Cts.13350

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Ribavirin Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Female / Humans / Male Language: English Journal: Clin Transl Sci Year: 2022 Document Type: Article Affiliation country: Cts.13350