Safety of sipavibart as a pre-exposure prophylaxis for COVID-19 in individuals at high risk of developing severe disease: results of the NOVELLA clinical study conducted in the Russian population
Aim. To evaluate the safety of sipavibart (AZD3152) for pre-exposure prophylaxis of COVID-19 in Russian population of participants at increased risk of developing severe COVID-19. Materials and methods. Randomized, double-blind phase 2 NOVELLA study included adults who had an increased risk of se...
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| Format: | Article |
| Language: | Russian |
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"Consilium Medicum" Publishing house
2024-12-01
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| Series: | Терапевтический архив |
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| Online Access: | https://ter-arkhiv.ru/0040-3660/article/viewFile/656021/171762 |
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| author | Daria S. Fomina Galina N. Salogub Alexey L. Maslyanskiy Galina I. Gridneva Vadim V. Ptushkin Maria Yu. Sitnikova Oksana G. Ni Valeriy V. Breder Mariia S. Shustova Nadezhda A. Kravtsova |
| author_facet | Daria S. Fomina Galina N. Salogub Alexey L. Maslyanskiy Galina I. Gridneva Vadim V. Ptushkin Maria Yu. Sitnikova Oksana G. Ni Valeriy V. Breder Mariia S. Shustova Nadezhda A. Kravtsova |
| author_sort | Daria S. Fomina |
| collection | DOAJ |
| description | Aim. To evaluate the safety of sipavibart (AZD3152) for pre-exposure prophylaxis of COVID-19 in Russian population of participants at increased risk of developing severe COVID-19.
Materials and methods. Randomized, double-blind phase 2 NOVELLA study included adults who had an increased risk of severe COVID-19 and inadequate response to vaccination against COVID-19. Participants were randomly assigned in a 3:1 ratio to receive a single IM injection of sipavibart (300 mg) or placebo, and they were followed for up to 181 days. The primary safety end point was the incidence of adverse events (AEs) after a single dose of sipavibart.
Results. 116 participants were randomized (87 in the sipavibart group and 29 in the placebo group). Overall, 51.7% of participants in the sipavibart group and 58.6% of participants in the placebo group had at least one AE, most of which were Grade 1–2 in severity. AEs were well balanced between groups, with no meaningful differences for any categories. The overall frequency, severity and types of AEs do not suggest any safety concerns and are considered to be reflective of events generally observed in this immunocompromised population. The most commonly reported AEs were associated with infections and infestations (34.5% in both groups). There were no immediate AE or AE of special interest reported in the study. There were no related cases of ≥ grade 3 AEs or SAEs reported.
Conclusion. The safety data in NOVELLA demonstrated that the safety profile of sipavibart for pre-exposure prophylaxis of COVID-19 in Russian participants is considered to be acceptable. |
| format | Article |
| id | doaj-art-263c39e59d2a4a7193c6b0d1d18ada0b |
| institution | DOAJ |
| issn | 0040-3660 2309-5342 |
| language | Russian |
| publishDate | 2024-12-01 |
| publisher | "Consilium Medicum" Publishing house |
| record_format | Article |
| series | Терапевтический архив |
| spelling | doaj-art-263c39e59d2a4a7193c6b0d1d18ada0b2025-08-20T03:01:07Zrus"Consilium Medicum" Publishing houseТерапевтический архив0040-36602309-53422024-12-0196121127113610.26442/00403660.2024.12.20310378635Safety of sipavibart as a pre-exposure prophylaxis for COVID-19 in individuals at high risk of developing severe disease: results of the NOVELLA clinical study conducted in the Russian populationDaria S. Fomina0https://orcid.org/0000-0002-5083-6637Galina N. Salogub1https://orcid.org/0000-0001-8951-1680Alexey L. Maslyanskiy2https://orcid.org/0000-0003-2427-4148Galina I. Gridneva3Vadim V. Ptushkin4https://orcid.org/0000-0002-9368-6050Maria Yu. Sitnikova5Oksana G. Ni6https://orcid.org/0000-0003-0994-0579Valeriy V. Breder7https://orcid.org/0000-0002-6244-4294Mariia S. Shustova8https://orcid.org/0000-0003-4765-5939Nadezhda A. Kravtsova9https://orcid.org/0000-0001-6250-5774City Clinical Hospital №52Almazov National Medical Research CentreAlmazov National Medical Research CentreNasonova Research Institute of RheumatologyBotkin City Clinical HospitalAlmazov National Medical Research CentreKommunarka Moscow Multidisciplinary Clinical CenterBlokhin National Medical Research Center of OncologyAstraZeneca Phamaceuticals LLCAstraZeneca Phamaceuticals LLCAim. To evaluate the safety of sipavibart (AZD3152) for pre-exposure prophylaxis of COVID-19 in Russian population of participants at increased risk of developing severe COVID-19. Materials and methods. Randomized, double-blind phase 2 NOVELLA study included adults who had an increased risk of severe COVID-19 and inadequate response to vaccination against COVID-19. Participants were randomly assigned in a 3:1 ratio to receive a single IM injection of sipavibart (300 mg) or placebo, and they were followed for up to 181 days. The primary safety end point was the incidence of adverse events (AEs) after a single dose of sipavibart. Results. 116 participants were randomized (87 in the sipavibart group and 29 in the placebo group). Overall, 51.7% of participants in the sipavibart group and 58.6% of participants in the placebo group had at least one AE, most of which were Grade 1–2 in severity. AEs were well balanced between groups, with no meaningful differences for any categories. The overall frequency, severity and types of AEs do not suggest any safety concerns and are considered to be reflective of events generally observed in this immunocompromised population. The most commonly reported AEs were associated with infections and infestations (34.5% in both groups). There were no immediate AE or AE of special interest reported in the study. There were no related cases of ≥ grade 3 AEs or SAEs reported. Conclusion. The safety data in NOVELLA demonstrated that the safety profile of sipavibart for pre-exposure prophylaxis of COVID-19 in Russian participants is considered to be acceptable.https://ter-arkhiv.ru/0040-3660/article/viewFile/656021/171762covid-19immunitypassive immunizationmonoclonal antibodiessipavibart |
| spellingShingle | Daria S. Fomina Galina N. Salogub Alexey L. Maslyanskiy Galina I. Gridneva Vadim V. Ptushkin Maria Yu. Sitnikova Oksana G. Ni Valeriy V. Breder Mariia S. Shustova Nadezhda A. Kravtsova Safety of sipavibart as a pre-exposure prophylaxis for COVID-19 in individuals at high risk of developing severe disease: results of the NOVELLA clinical study conducted in the Russian population Терапевтический архив covid-19 immunity passive immunization monoclonal antibodies sipavibart |
| title | Safety of sipavibart as a pre-exposure prophylaxis for COVID-19 in individuals at high risk of developing severe disease: results of the NOVELLA clinical study conducted in the Russian population |
| title_full | Safety of sipavibart as a pre-exposure prophylaxis for COVID-19 in individuals at high risk of developing severe disease: results of the NOVELLA clinical study conducted in the Russian population |
| title_fullStr | Safety of sipavibart as a pre-exposure prophylaxis for COVID-19 in individuals at high risk of developing severe disease: results of the NOVELLA clinical study conducted in the Russian population |
| title_full_unstemmed | Safety of sipavibart as a pre-exposure prophylaxis for COVID-19 in individuals at high risk of developing severe disease: results of the NOVELLA clinical study conducted in the Russian population |
| title_short | Safety of sipavibart as a pre-exposure prophylaxis for COVID-19 in individuals at high risk of developing severe disease: results of the NOVELLA clinical study conducted in the Russian population |
| title_sort | safety of sipavibart as a pre exposure prophylaxis for covid 19 in individuals at high risk of developing severe disease results of the novella clinical study conducted in the russian population |
| topic | covid-19 immunity passive immunization monoclonal antibodies sipavibart |
| url | https://ter-arkhiv.ru/0040-3660/article/viewFile/656021/171762 |
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