CAMOSTAT IS NOT EFFECTIVE for MILD-MODERATE COVID-19 in A PHASE 2 TRIAL of ACTIV-2
Topics in Antiviral Medicine
; 30(1 SUPPL):41, 2022.
Artículo
en Inglés
| EMBASE | ID: covidwho-1880388
ABSTRACT
Background:
Camostat, a serine protease inhibitor, prevents activation of the SARS-CoV-2 spike protein and blocks SARS-CoV-2 infection in vitro. We studied the safety and antiviral and clinical efficacy of orally administered camostat in non-hospitalized adults with mild-moderate COVID-19.Methods:
ACTIV-2/A5401 is a platform trial to evaluate therapies for non-hospitalized adults with mild-moderate COVID-19. In a Phase II portion of the study, participants were enrolled within 10 days of COVID-19 related symptom onset and randomized to camostat 200 mg orally every 6 hours for 7 days or the pooled placebo group. Objectives were to evaluate the safety and efficacy of camostat to reduce the duration of COVID-19 symptoms and increase the proportion of participants with SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) from nasopharyngeal (NP) swabs on days 3, 7, and 14. Participants completed a study diary from day 0 to day 28 scoring COVID-19 symptoms as absent, mild, moderate, or severe.Results:
Of the 224 participants enrolled from 54 US sites, 215 participants (108 camostat, 107 placebo) initiated study intervention and formed the modified intent-to-treat population. Fifty-four percent were female, >99% cis-gender, 85% White, 9% Black, and 51% Latinx. Median age was 37 years;47% reported ≤5 days of symptoms at study entry and 26% met the protocol definition of higher risk of progression to severe COVID-19. Most frequent symptoms on day 0 were cough (86%), fatigue (85%), nasal obstruction/congestion (71%) and body/muscle aches (71%). There was no significant difference between camostat and placebo arms in grade 3 or higher adverse events (7.4% vs. 6.5%, respectively). Median (Q1, Q3) time to symptom improvement was 9 days for both camostat (5, 20) and placebo (6, 19). There were no significant differences in the proportion of participants with NP SARS-CoV-2 RNA<="" div="">Conclusion:
Camostat was well-tolerated. Despite compelling in vitro data, camostat did not show evidence of antiviral or clinical efficacy in ACTIV-2/A5401. This highlights the critical importance of randomized controlled trials in the evaluation of therapies for COVID-19.
antivirus agent; camostat; placebo; adult; clinical trial; conference abstract; controlled study; coronavirus disease 2019; coughing; drug safety; drug therapy; fatigue; female; gender; Hispanic; human; in vitro study; limit of quantitation; male; myalgia; nasopharyngeal swab; nonhuman; nose obstruction; oral drug administration; phase 2 clinical trial; randomized controlled trial; Severe acute respiratory syndrome coronavirus 2
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Colección:
Bases de datos de organismos internacionales
Base de datos:
EMBASE
Tipo de estudio:
Estudio experimental
/
Ensayo controlado aleatorizado
Idioma:
Inglés
Revista:
Topics in Antiviral Medicine
Año:
2022
Tipo del documento:
Artículo
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