Sipavibart (1) – Kavigale®

• Clinical trials
  • The SUPERNOVA trial is a Phase I/III trial investigating pre-exposure prophylaxis for COVID-19. The double-blind, randomised, controlled Phase III trial is investigating the comparison of sipavibart with tixagevimab/cilgavimab or placebo for pre-exposure prophylaxis against COVID-19 in immunocompromised adults and adolescents aged 12 years and over.

a) Adults who are immunocompromised due to a medical condition or immunosuppressive treatments, with an indication for pre-exposure prophylaxis against COVID-19

• The additional benefit is not proven.
• mortality
  • No statistically significant difference was observed between the treatment groups for the endpoint of overall mortality.
• Morbidity – Confirmed symptomatic COVID-19
  • For the endpoint ‘confirmed symptomatic COVID-19’, there is no statistically significant difference between the treatment groups.
• Morbidity – Severe COVID-19
  • For the endpoint ‘severe COVID-19’, there was no statistically significant difference between the treatment groups.
• quality of life
  • Endpoints relating to health-related quality of life were not assessed in the study.
• Side effects
  • For the endpoints SUEs (up to day 181) and severe AEs (up to day 91), there was no statistically significant difference between the treatment groups in either case.
  • No suitable data are available for the benefit assessment regarding the endpoint ‘withdrawal due to adverse events’.
• Overall assessment
  • Overall, for adults receiving pre-exposure prophylaxis against COVID-19, there are neither advantages nor disadvantages for sipavibart compared with placebo in the endpoint categories of mortality, morbidity and side effects. No data are available on health-related quality of life. An additional benefit of sipavibart over the appropriate comparator therapy, ‘watchful waiting’, is therefore not proven for this patient population.

b) Adolescents aged 12 years and over weighing at least 40 kg who are immunocompromised due to a medical condition or immunosuppressive treatments, with an indication for pre-exposure prophylaxis against COVID-19

• An additional benefit is not proven.
• For adolescents aged 12 to under 18 years with a body weight of at least 40 kg, for pre-exposure prophylaxis against COVID-19, no data are available for comparison with the appropriate comparator therapy. Furthermore, no sufficient justification is provided for the extrapolation of the results from adults to adolescents aged 12 years and over.
• Overall assessment
  • For adolescents aged 12 to under 18 years with a body weight of at least 40 kg, no data are available for comparison with the appropriate comparator therapy. The additional benefit of Sipavibart compared with the appropriate comparator therapy for pre-exposure prophylaxis of COVID-19 in adolescents aged 12 to under 18 years is not proven.

Courtesy translation only, please refer to the German original.