NECTAR
Trial question
What is the role of fostamatinib in hospitalized patients with COVID-19 infection and hypoxemia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
47.5% female
52.5% male
N = 400
400 patients (190 female, 210 male).
Inclusion criteria: hospitalized patients with COVID-19 and hypoxemia.
Key exclusion criteria: onset of COVID-19 symptom > 14 days before randomization; hospitalization with hypoxemia for > 72 hours before randomization; pregnancy or lactation; incarceration; ESRD on dialysis; hemodynamic instability; severe renal artery stenosis.
Interventions
N=199 fostamatinib (at an oral dose of 150 mg BID for 14 days).
N=201 placebo (matching placebo for 14 days).
Primary outcome
Mean oxygen-free days to day 28
13.4 days
14.2 days
14.2 days
10.6 days
7.1 days
3.5 days
0.0 days
Fostamatinib
Placebo
No significant
difference ↔
No significant difference in mean oxygen-free days to day 28 (13.4 days vs. 14.2 days; MD -1.26, 95% CI -3.52 to 1).
Secondary outcomes
No significant difference in death at day 28 (11.3% vs. 8.1%; AD 3.2%, 95% CI -2.7 to 9.1).
No significant difference in alive and respiratory failure free at day 28 (85.5% vs. 88.9%; ARD -3.5, 95% CI -10.3 to 3.2).
Safety outcomes
No significant differences in serious adverse events, ALT.
Significant difference in AST elevation (11.6% vs. 5.5%).
Conclusion
In hospitalized patients with COVID-19 and hypoxemia, fostamatinib was not superior to placebo with respect to mean oxygen-free days to day 28.
Reference
Sean P Collins, Matthew S Shotwell, Jeffrey R Strich et al. Fostamatinib for Hospitalized Adults With COVID-19 and Hypoxemia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2448215.
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