Description of medical intervention
Tixagevimab/Cilgavimab, groups:15, coronavirus infection
DISEASE PROGRESSION, VIRUS, CORONAVIRUS INFECTION, DISEASE COURSE, RECRUITMENT
The study included 77 patients diagnosed with COVID-19 as outpatients by qualitative determination of the SARS-CoV-2 antigen or SARS-CoV-2 RNA, with mild or moderate disease course and a high risk of disease progression. The severity of coronavirus infection and the risks were determined according to the Russian Interim Clinical Guidelines on COVID-19 (The scheme of patient recruitment for the study. T/C, Tixagevimab/Cilgavimab; PCR, polymerase chain reaction; IM, intamuscularly; IV, intravenously; mg, milligram; kg, kilogram; Regd, Regdanvimab; VNA, virus neutralizing antibody; CRP, C-reactive protein. Patients were admitted to the Day patient department. The patients were divided into four groups: 15 patients who received Tixagevimab/Cilgavimab IV 300 mg; 23 patients who received Tixagevimab/Cilgavimab IM 300 mg; 15 patients who received Tixagevimab/Cilgavimab IV 600 mg; 24 patients who received Regdanvimab IV at a dose of 40 mg/kg of body weight. PCR, VNA titer, lymphocyte count, PCR, fibrinogen, and D-dimer were monitored on day 0. On day 4, all the above parameters were monitored, and the outcomes were recorded.The patients were divided into four groups:15 patients who received Tixagevimab/Cilgavimab IV 300 mg.23 patients who received Tixagevimab/Cilgavimab IM 300 mg.15 patients who received Tixagevimab/Cilgavimab IV 600 mg.24 patients who received Regdanvimab IV at a dose of 40 mg/kg of body weight.No randomization was performed as it was a real world clinical study.The administration of drugs in all groups of patients was regulated by the Russian Interim Clinical Guidelines on COVID-19 (Immediately before the drug administration (Day 0) as part of routine clinical practice to assess the severity of COVID-19 all patients underwent the following tests and procedures: full blood count, biochemical blood assay (including CRP and lactate dehydrogenase [LDH]), coagulogram (including fibrinogen and D-dimer), chest СТ scan, ECG, nasopharyngeal swab for polymerase chain reaction (PCR) testing to detect SARS-CoV-2 RNA. Additionally, after signing the informed consent to participate in the study the patients also underwent blood serum sampling for the test of virus neutralization activity before the administration of mAbs and an hour after the administration of mAbs. On Day 4 after the administration of Tixagevimab/Cilgavimab or Regdanvimab the patients underwent the following tests and procedures: full blood count, biochemical blood assay (including CRP and LDH), coagulogram (including fibrinogen and D-dimer), chest СТ scan, ECG, nasopharyngeal swab for PCR testing to detect SARS-CoV-2 RNA and blood serum testing for virus neutralization activity.