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A Randomised Phase II Trial in Early COVID-19, Assessing Use of Camostat by Blocking SARS-CoV-2 Spike Protein-initiated Membrane Fusion

Dhaliwal et al., NCT04455815, SPIKE-1, NCT04455815
Mar 2022  
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Hospitalization 14% Improvement Relative Risk Camostat  SPIKE-1  EARLY TREATMENT  RCT Is early treatment with camostat beneficial for COVID-19? RCT 34 patients in the United Kingdom Trial underpowered to detect differences c19early.org Dhaliwal et al., NCT04455815, March 2022 Favorscamostat Favorscontrol 0 0.5 1 1.5 2+
Early terminated RCT with 34 patients showing no significant differences with camostat treatment.
Standard of Care (SOC): SOC for COVID-19 in the study country, the United Kingdom, is poor with low average efficacy for approved treatments1. The United Kingdom focused on expensive high-profit treatments, approving only one low-cost treatment, which required a prescription and had limited adoption. The high-cost prescription treatment strategy reduces the probability of treatment—especially early—due to access and cost barriers, and eliminates complementary and synergistic benefits seen with many low-cost treatments.
risk of hospitalization, 14.3% lower, RR 0.86, p = 1.00, treatment 2 of 14 (14.3%), control 3 of 18 (16.7%), NNT 42.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Dhaliwal et al., 3 Mar 2022, Randomized Controlled Trial, United Kingdom, preprint, 1 author, trial NCT04455815 (history) (SPIKE-1).
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