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

TMPRSS2 inhibitors for COVID-19

21st treatment shown to reduce risk in April 2021, now with p = 0.00063 from 29 studies.
Lower risk for mortality, ventilation, and recovery.

No treatment is 100% effective.
Protocols combine treatments.

Early terminated RCT with 34 patients showing no significant differences with camostat treatment.
Standard of Care (SOC) for COVID-19 in the study country, the United Kingdom, is very poor with very low average efficacy for approved treatments1. The United Kingdom focused on expensive high-profit treatments, approving only one low-cost early treatment, which required a prescription and had limited adoption. The high-cost prescription treatment strategy reduces the probability of early treatment due to access and cost barriers, and eliminates complementary and synergistic benefits seen with many low-cost treatments.
Study covers TMPRSS2 inhibitors and camostat.
OutcomeImprovementEffect · pTreatmentControl
risk of hospitalization 14.3% lower · RR 0.86 · p = 1.00 14.3% lowerRR 0.86p = 1.00 2 of 14 (14.3%) 3 of 18 (16.7%) 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).
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org November 2026 United Kingdom Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines USA Brazil France Italy Canada Pakistan Spain Vietnam Japan Nepal Iran Bangladesh Ethiopia Ghana Mexico South Korea Saudi Arabia Algeria Morocco Yemen Poland Uzbekistan India China Venezuela DR Congo Madagascar Thailand Uganda Egypt Nigeria Taiwan Fiji Zambia Bosnia-Herzegovina Dominican Republic Bolivia Côte d'Ivoire Eritrea Togo Iceland New Zealand Mongolia Czechia Belarus Israel Haiti North Macedonia Hong Kong Qatar Panama Serbia The United Kingdom favored high-profit treatments.The average efficacy of treatments was moderate.High-cost protocols reduce early treatment, andforgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org November 2026 United Kingdom Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines USA Brazil France Italy Canada Pakistan Spain Vietnam Japan Iran Bangladesh Ethiopia Ghana Mexico South Korea Saudi Arabia Algeria Morocco Yemen Poland Uzbekistan India China Venezuela DR Congo Madagascar Thailand Uganda Egypt Taiwan Fiji Zambia Dominican Rep. Bolivia Côte d'Ivoire Eritrea Mongolia Czechia Belarus Israel North Macedonia Hong Kong Qatar Panama Serbia The UK favored high-profit treatments.The average efficacy was moderate.High-cost protocols reduce early treatment,and forgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%