Abstract: Articles
Efficacy and safety of sipavibart for prevention of COVID-19
in individuals who are immunocompromised (SUPERNOVA):
a randomised, controlled, double-blind, phase 3 trial
Ghady Haidar*, Steven Thomas*, Paul Loubet, Ross I Baker, Thomas Benfield, Jim Boonyaratanakornkit, Sasisopin Kiertiburanakul, Alfred H J Kim,
Erin E Longbrake, Jean-Michel Molina, Roger Paredes, David Tucker, Alison Uriel, Julia Weinmann-Menke, Anastasia A Aksyuk, Lindsay E Clegg,
Alexander Currie, Haitao Yang, Karin Flyrin, Michael Gibbs, Manish Shroff, John L Perez, Lee-Jah Chang, Taylor S Cohen, on behalf of the
SUPERNOVA study group†
Summary
Background Sipavibart is an anti-spike monoclonal antibody that neutralises SARS-CoV-2 with exceptions, including
Phe456Leu-containing variants (eg, KP.2* and KP.3*). This trial assessed sipavibart efficacy and safety for prevention
of symptomatic COVID-19 in participants who are immunocompromised.
Methods In this ongoing, double-blind, international, phase 3 trial, we enrolled participants who were
immunocompromised and aged 12 years or older at 197 hospitals, university health centres, and clinical trial units in
18 countries. Participants were randomly allocated 1:1 to a sipavibart group (intramuscular sipavibart 300 mg on days
1 and 181) or a comparator group (tixagevimab 300 mg–cilgavimab 300 mg on day 1 and placebo on day 181 or placebo
on days 1 and 181), stratified by previous COVID-19 vaccination and infection status and use of tixagevimab–
cilgavimab. The primary efficacy outcomes were symptomatic COVID-19 caused by any variant or symptomatic
COVID-19 caused by non-Phe456Leu-containing variants within 181 days of dosing, assessed in the SARS-CoV-2negative set, comprising all participants without a positive RT-PCR test for SARS-CoV-2 at baseline and who received
at least one trial intervention dose. Safety outcomes for adverse events were assessed 90 days following the first dose
and for serious adverse events throughout the study in the safety analysis set (ie, all participants who received at least
one injection of sipavibart or comparator). This study is registered with ClinicalTrials.gov, NCT05648110.
Findings Participants were screened from March 31 to Oct 27, 2023; 3349 participants (56·8% female) were randomly
assigned: 1674 to the sipavibart group (five no first dose; 1669 sipavibart) and 1675 to the comparator group (nine no
first dose; 1105 tixagevimab–cilgavimab and 561 placebo). Within 181 days of dosing, 122 (7·4%) of 1649 participants
in the sipavibart group and 178 (10·9%) of 1631 participants in the comparator group had symptomatic COVID-19
due to any variant (relative risk reduction [RRR] 34·9% [97·5% CI 15·0 to 50·1]; p=0·0006), 54 (3·3%) participants in
the sipavibart group and 90 (5·5%) participants in the comparator group had symptomatic COVID-19 due to nonPhe456Leu-containing variants (RRR 42·9% [95% CI 19·9 to 59·3]; p=0·0012), and 47 (2·9%) participants in the
sipavibart group and 64 (3·9%) participants in the comparator group had symptomatic COVID-19 due to Phe456Leucontaining variants (30·4% [–1·8 to 52·5]). Adverse events occurred in 833 (49·9%) of 1671 participants in the
sipavibart group and 857 (51·5%) of 1663 participants in the comparator group within 3 months of the first dose. One
COVID-19-related death occurred in the comparator group. Serious adverse events considered related to trial
intervention occurred in two (0·1%) of 1671 participants in the sipavibart group and..
DOI record:
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