Sotrovimab
- Generic Name
- Sotrovimab
- Brand Names
- Xevudy
- Drug Type
- Biotech
- CAS Number
- 2423014-07-5
- Unique Ingredient Identifier
- 1MTK0BPN8V
- Background
Sotrovimab (VIR-7831), also known as GSK4182136, is a monoclonal antibody that can neutralize the SARS-CoV-2 virus. Sotrovimab was initially been granted emergency use authorization (EUA) to treat mild-to-moderate COVID-19 on May 26, 2021, based on interim results from a clinical trial, where sotrovimab was found to reduce the risk of death or hospitalization in high-risk adults with COVID-19 in the outpatient setting. However, in April 2022, the FDA removed the EUA for sotrovimab due to the rising COVID-19 cases caused by the Omicron BA.2 sub-variant, where the drug is ineffective.
Sotrovimab was granted marketing authorization in the European Union in December 2021 under the brand name Xevudy.
- Indication
In Europe, sotrovimab is indicated for the treatment of COVID-19 in patients ≥12 years old and weighing ≥40kg who do not require supplemental oxygen and are at high risk of progressing to severe disease.
- Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain
- Conditions
- COVID-19
- Interventions
- First Posted Date
- 2022-06-01
- Last Posted Date
- 2022-06-01
- Lead Sponsor
- Abu Dhabi Health Services Company
- Target Recruit Count
- 20000
- Registration Number
- NCT05398718
- Locations
- 🇧🇭
The National Taskforce for combating COVID-19, Royal Medical Services., Manama, Bahrain
Non-inferiority Trial on Treatments in Early COVID-19
- Conditions
- COVID-19
- Interventions
- First Posted Date
- 2022-04-11
- Last Posted Date
- 2023-11-07
- Target Recruit Count
- 536
- Registration Number
- NCT05321394
- Locations
- 🇮🇹
Azienda Ospedaliera Cannizzaro, Catania, Italy
🇮🇹Azienda Ospedaliera dei Colli, presidio ospedaliero Cotugno, Napoli, Italy
🇮🇹Azienda Ospedaliera S. Maria della Misericordia, Perugia, Italy
Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19
- First Posted Date
- 2022-03-31
- Last Posted Date
- 2024-10-14
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 217
- Registration Number
- NCT05305651
- Locations
- 🇬🇧
GSK Investigational Site, Plymouth, United Kingdom
Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)
- First Posted Date
- 2022-03-15
- Last Posted Date
- 2022-11-08
- Lead Sponsor
- Vir Biotechnology, Inc.
- Target Recruit Count
- 504
- Registration Number
- NCT05280717
- Locations
- 🇺🇸
Investigative Site, West Jordan, Utah, United States
COVID-19 and Disease Progression to the Severe Form: a Study on the Use of Monoclonal Antibodies Against SARS-CoV-2
- Conditions
- COVID-19
- First Posted Date
- 2022-03-07
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- University of Milano Bicocca
- Target Recruit Count
- 251
- Registration Number
- NCT05268601
- Locations
- 🇮🇹
Asst-Monza Ospedale San Gerardo, Monza, Lombardia, Italy
A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 in Immunocompromised Individuals
- First Posted Date
- 2022-01-27
- Last Posted Date
- 2024-08-15
- Lead Sponsor
- Sophia Koo, M.D.
- Target Recruit Count
- 93
- Registration Number
- NCT05210101
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Brigham and Women's Hospital, Boston, Massachusetts, United States
Non-inferiority Trial on Monoclonal Antibodies in COVID-19
- Conditions
- COVID-19
- Interventions
- First Posted Date
- 2022-01-25
- Last Posted Date
- 2022-07-26
- Target Recruit Count
- 319
- Registration Number
- NCT05205759
- Locations
- 🇮🇹
AOU Città della Salute e Scienza, Presidio Molinette, Torino, Italy
🇮🇹PO Garibaldi Nesima, Catania, Italy
🇮🇹Azienda Socio-Sanitaria Territoriale di Cremona, Cremona, Italy
TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2
- Conditions
- COVID-19
- Interventions
- First Posted Date
- 2022-01-18
- Last Posted Date
- 2023-11-22
- Target Recruit Count
- 1000
- Registration Number
- NCT05195060
- Locations
- 🇳🇱
Amsterdam University Medical Centre, Amsterdam, Noord-Holland, Netherlands
🇳🇱Amsterdam University Medical centre - VUMC, Amsterdam, Noord Holland, Netherlands
🇳🇱Leiden universitair medisch centrum, Leiden, Netherlands
Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study
- Conditions
- Malignant Solid NeoplasmCOVID-19 InfectionHematopoietic and Lymphoid Cell Neoplasm
- Interventions
- First Posted Date
- 2021-11-26
- Last Posted Date
- 2025-02-13
- Lead Sponsor
- Fred Hutchinson Cancer Center
- Target Recruit Count
- 20
- Registration Number
- NCT05135650
- Locations
- 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
- Conditions
- COVID-19
- Interventions
- Drug: Nirmatrelvir/ritonavir (e.g. PAXLOVID™)Drug: Molnupiravir and nirmatrelvir/ritonavir (e.g. PAXLOVID™)Other: No treatmentDrug: Monoclonal antibodiesDrug: Molnupiravir
- First Posted Date
- 2021-09-13
- Last Posted Date
- 2024-10-28
- Lead Sponsor
- University of Oxford
- Target Recruit Count
- 3800
- Registration Number
- NCT05041907
- Locations
- 🇳🇵
Sukraraj Tropical & Infectious Disease Hospital, Kathmandu, Nepal
🇧🇷Universidade Federal de Minas Gerais, Minas Gerais, Brazil
🇱🇦Laos-Oxford-Mahosot Wellcome Trust Research Unit, Vientiane, Lao People's Democratic Republic
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.