A Phase II Randomized, Double-blind Study to Evaluate the Safety, Neutralizing Activity and Efficacy of AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants Having an Increased Risk for Inadequate Response to Active Immunization (NOVELLA)

AstraZeneca, NCT06057064, NOVELLA, NCT06057064, May 2024
Mortality -267% improvement lower risk ← → higher risk Symp. case 33% Sipavibart for COVID-19  NOVELLA  PROPHYLAXIS RCT Is prophylaxis with sipavibart beneficial for COVID-19? Double-blind RCT 116 patients in Russia Trial underpowered to detect differences c19early.org AstraZeneca, NCT06057064, May 2024 0 0.5 1 1.5 2+ RR
RCT 116 patients in Russia, showing improved nAb titers with sipavibart prophylaxis, but no significant difference for mortality or symptomatic cases.
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risk of death, 266.7% higher, RR 3.67, p = 1.00, treatment 2 of 87 (2.3%), control 0 of 29 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of symptomatic case, 33.3% lower, RR 0.67, p = 0.64, treatment 4 of 87 (4.6%), control 2 of 29 (6.9%), NNT 44.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
AstraZeneca et al., 17 May 2024, Double Blind Randomized Controlled Trial, placebo-controlled, Russia, preprint, 1 author, trial NCT06057064 (history) (NOVELLA). Contact: information.center@astrazeneca.com.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org September 2026 Russia Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines USA Brazil France Italy Canada Pakistan Spain Vietnam Japan 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 Dominican Republic Bolivia Bulgaria Greece Slovakia Iceland New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel Haiti North Macedonia Hong Kong Qatar Panama Serbia Russia favored low-cost treatments.The average efficacy of treatments was moderate.Low-cost treatments improve early treatment, andprovide 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 September 2026 Russia Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines USA Brazil France Italy Canada Pakistan Spain Vietnam Japan 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 Dominican Rep. Bolivia Côte d'Ivoire Bulgaria Greece Slovakia New Zealand Trinidad and Tobago Mongolia Zimbabwe Czechia Belarus Israel North Macedonia Hong Kong Qatar Panama Serbia Russia favored low-cost treatments.The average efficacy was moderate.Low-cost protocols improve early treatment,and add complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
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