PMID- 37520411
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231106
IS  - 2328-8957 (Print)
IS  - 2328-8957 (Electronic)
IS  - 2328-8957 (Linking)
VI  - 10
IP  - 7
DP  - 2023 Jul
TI  - Safety, Virology, Pharmacokinetics, and Clinical Experience of High-Dose 
      Intravenous Sotrovimab for the Treatment of Mild to Moderate COVID-19: An 
      Open-Label Clinical Trial.
PG  - ofad344
LID - 10.1093/ofid/ofad344 [doi]
LID - ofad344
AB  - BACKGROUND: Five hundred milligrams of intravenous (IV) sotrovimab has been shown 
      to be well tolerated and efficacious against pre-Omicron strains in treating 
      patients with mild to moderate coronavirus disease 2019 (COVID-19) at high risk 
      for disease progression. METHODS: This was an open-label, single-arm substudy of 
      phase 3 COMET-TAIL (NCT04913675) assessing the safety and tolerability of a 2000 
      mg IV dose of sotrovimab. Symptomatic patients (aged >/=18 years) with COVID-19 at 
      high risk for progression were enrolled from June 30 through July 11, 2022, when 
      Omicron BA.5, BA.2.12.1, and BA.4 were the predominant circulating variants in 
      the United States. The primary end point was the occurrence of adverse events 
      (AEs), serious AEs (SAEs), AEs of special interest, and COVID-19 disease-related 
      events (DREs) through day 8. Safety, pharmacokinetics, viral load, and 
      hospitalization >24 hours for acute management of illness or death through day 29 
      were assessed. RESULTS: All participants (n = 81) were Hispanic, 58% were female, 
      and 51% were aged >/=55 years. Through day 8, no AEs, including infusion-related 
      reactions or hypersensitivity, were reported; 2 participants reported DREs (mild 
      cough, n = 2). One SAE (acute myocardial infarction), which was considered 
      unrelated to sotrovimab or COVID-19 by the investigator, occurred on day 27 and 
      was the only hospitalization reported. Maximum serum concentration (geometric 
      mean) was 745.9 microg/mL. Viral load decreased from baseline through day 29; only 2 
      (3%) participants had a persistently high viral load (>/=4.1 log(10) copies/mL) at 
      day 8. CONCLUSIONS: Two thousand milligrams of IV sotrovimab was well tolerated, 
      with no safety signals observed. TRIAL REGISTRATION: ClinicalTrials.gov 
      Identifier: NCT04913675.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of 
      Infectious Diseases Society of America.
FAU - Moya, Jaynier
AU  - Moya J
AD  - Pines Care Research Center, Pembroke Pines, Florida, USA.
FAU - Temech, Marisol
AU  - Temech M
AD  - Vir Biotechnology, Inc., San Francisco, California, USA.
FAU - Parra, Sergio
AU  - Parra S
AD  - Vir Biotechnology, Inc., San Francisco, California, USA.
FAU - Juarez, Erick
AU  - Juarez E
AD  - Florida International Medical Research, Miami, Florida, USA.
FAU - Hernandez-Loy, Reinaldo
AU  - Hernandez-Loy R
AD  - Dynamic Medical Research, LLC, Miami, Florida, USA.
FAU - Gutierrez, Juan C Moises
AU  - Gutierrez JCM
AD  - Continental Clinical Research, Miami, Florida, USA.
FAU - Diaz, Jorge
AU  - Diaz J
AD  - Doral Medical Research, Doral, Florida, USA.
FAU - Hussain, Rubaba
AU  - Hussain R
AD  - RH Medical Urgent Care, New York, New York, USA.
FAU - Segal, Scott
AU  - Segal S
AD  - GSK, Collegeville, Pennsylvania, USA.
FAU - Xu, Claire
AU  - Xu C
AD  - GSK, Collegeville, Pennsylvania, USA.
FAU - Skingsley, Andrew
AU  - Skingsley A
AD  - GSK, Brentford, UK.
FAU - Schnell, Gretja
AU  - Schnell G
AD  - Vir Biotechnology, Inc., San Francisco, California, USA.
FAU - El-Zailik, Asma
AU  - El-Zailik A
AD  - Vir Biotechnology, Inc., San Francisco, California, USA.
FAU - Sager, Jennifer E
AU  - Sager JE
AD  - Vir Biotechnology, Inc., San Francisco, California, USA.
FAU - Aldinger, Melissa
AU  - Aldinger M
AD  - Vir Biotechnology, Inc., San Francisco, California, USA.
FAU - Alexander, Elizabeth L
AU  - Alexander EL
AD  - Vir Biotechnology, Inc., San Francisco, California, USA.
FAU - Acloque, Gerard
AU  - Acloque G
AD  - Universal Medical and Research Center, Miami, Florida, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT04913675
PT  - Journal Article
DEP - 20230710
PL  - United States
TA  - Open Forum Infect Dis
JT  - Open forum infectious diseases
JID - 101637045
PMC - PMC10372714
OTO - NOTNLM
OT  - COVID-19
OT  - Omicron
OT  - SARS-CoV-2
OT  - monoclonal antibody
OT  - sotrovimab
COIS- Potential conflicts of interest. S.P., M.T., G.S., A.E.-Z., J.S., M.A., and E.A. 
      are employees of Vir Biotechnology, Inc. and report stock ownership in Vir 
      Biotechnology, Inc. and third-party funding from GSK to Vir Biotechnology, Inc. 
      for the submitted work. S.S., C.X., and A.S. are employees of GSK and report 
      stock ownership in GSK. J.M., E.J., R.H.-L., J.M.G., J.D., R.H., and G.A. report 
      acting as a trial investigator for Vir Biotechnology, Inc. and receiving 
      nonfinancial support from Vir Biotechnology, Inc. during the conduct of the 
      study.
EDAT- 2023/07/31 06:42
MHDA- 2023/07/31 06:43
PMCR- 2023/07/10
CRDT- 2023/07/31 04:51
PHST- 2023/06/26 00:00 [received]
PHST- 2023/07/06 00:00 [accepted]
PHST- 2023/07/31 06:43 [medline]
PHST- 2023/07/31 06:42 [pubmed]
PHST- 2023/07/31 04:51 [entrez]
PHST- 2023/07/10 00:00 [pmc-release]
AID - ofad344 [pii]
AID - 10.1093/ofid/ofad344 [doi]
PST - epublish
SO  - Open Forum Infect Dis. 2023 Jul 10;10(7):ofad344. doi: 10.1093/ofid/ofad344. 
      eCollection 2023 Jul.