Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)

Bobrow et al., NCT04478071, VSTAT, NCT04478071, Mar 2025
Late treatmentDouble-blind RCT · NCT04478071 · 448 patients · USA
Vadadustat for COVID-19
VSTAT Bobrow et al. NCT04478071 · March 2025
Outcome
Improvement
Relative Risk · 95% CI
Lower progression with vadadustat
Not statistically significant · p = 0.36
RCT 448 hospitalized COVID-19 patients in the USA showing no significant differences with vadadustat.
Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments1. Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
OutcomeImprovementEffect · pTreatmentControl
risk of death 2.7% higher · RR 1.03 · p = 1.00 2.7% higherRR 1.03p = 1.00 19 of 221 (8.6%) 19 of 227 (8.4%) treatment 19 of 221 (8.6%), control 19 of 227 (8.4%)day 28
risk of progression 16.2% lower · RR 0.84 · p = 0.36 16.2% lowerRR 0.84p = 0.36 43 of 216 (19.9%) 53 of 223 (23.8%) treatment 43 of 216 (19.9%), control 53 of 223 (23.8%)NIAID ordinal score ≥6NNT 26day 14
risk of no recovery 8.4% lower · RR 0.92 · p = 0.60 8.4% lowerRR 0.92p = 0.60 58 of 214 (27.1%) 66 of 223 (29.6%) treatment 58 of 214 (27.1%), control 66 of 223 (29.6%)MSOFA 0NNT 40day 14

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates.

Bobrow et al., 25 Mar 2025, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 1 author, average treatment delay 7.0 days, trial NCT04478071 (history) (VSTAT). Contact: Bentley.J.Bobrow@uth.tmc.edu.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org November 2026 USA Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines Vietnam Japan Argentina Nepal Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Uzbekistan India China Venezuela DR Congo Madagascar Thailand Uganda Egypt Nigeria Taiwan Fiji Zambia Bosnia-Herzegovina Jordan Georgia Switzerland Dominican Republic Bolivia Côte d'Ivoire Eritrea Togo Bulgaria Greece Slovakia Iceland New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel Haiti North Macedonia Hong Kong Qatar Panama Serbia USA favored high-profit treatments.The average efficacy of treatments was very low.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 USA Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines Vietnam Japan Argentina Nepal Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Uzbekistan India China Venezuela DR Congo Madagascar Thailand Uganda Egypt Taiwan Fiji Zambia Jordan Georgia Switzerland Dominican Rep. Bolivia Côte d'Ivoire Eritrea Togo Sri Lanka Bulgaria Greece Slovakia New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel North Macedonia Hong Kong Qatar Panama Serbia USA favored high-profit treatments.The average efficacy was very low.High-cost protocols reduce early treatment,and forgo complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
Late treatment
is less effective