SARS CoV 2 Infection Clinical Trial
Official title:
A Safety and Tolerability Study of Sotrovimab (VIR-7831) Prophylaxis Against COVID-19 Infection in Immunocompromised Individuals With Impaired SARS-CoV-2 Humoral Immunity
This is an open-label study examining the safety and tolerability of sotrovimab, administered in two sequential doses as prophylaxis in immunocompromised patients with impaired humoral immunity against SARS-CoV-2.
This open-label study will evaluate the safety and tolerability of sotrovimab, administered in two sequential doses, as COVID-19 prophylaxis in immunocompromised patients with impaired humoral immunity against SARS-CoV-2. Approximately 200 patients will be enrolled in this study, 10 patients in a lead-in PK cohort to determine the optimal dosing interval between the first and second dose of sotrovimab and assess the safety and tolerability of the drug, 50 patients (including the 10 patients in the lead-in PK cohort) in a safety and tolerability lead-in cohort to examine rates of infusion-related reactions (IRR) with a 30-minute sotrovimab IV infusion, and 150 patients in an expansion cohort for further assessment of the safety and tolerability of sotrovimab in this patient population, with the sotrovimab infusion duration determined by the rate of IRRs in the 50-patient safety and tolerability lead-in cohort. ;
| NCT number | NCT05210101 |
| Study type | Interventional |
| Source | Brigham and Women's Hospital |
| Contact | Katherine Beluch |
| Phone | (617)732-5500 |
| [email protected] | |
| Status | Recruiting |
| Phase | Phase 2 |
| Start date | January 31, 2022 |
| Completion date | June 1, 2024 |