PMID- 36461006
OWN - NLM
STAT- MEDLINE
DCOM- 20221206
LR  - 20221207
IS  - 1471-2334 (Electronic)
IS  - 1471-2334 (Linking)
VI  - 22
IP  - 1
DP  - 2022 Dec 3
TI  - Sotrovimab use in Japanese inpatients with COVID-19: post-infusion adverse 
      events.
PG  - 902
LID - 10.1186/s12879-022-07889-z [doi]
LID - 902
AB  - BACKGROUND: Sotrovimab neutralizing SARS-CoV-2 remained effective at the advent 
      of B.1 lineage of the Omicron variant in outpatients. Primarily for hospitalized 
      patients, however, the Japanese government regulated to administer this antibody 
      agent. As this regulation enabled close monitoring in inpatients to investigate 
      post-infusion adverse events (AEs) and efficacy, we attempted a retrospective 
      study while the Omicron BA.1 lineage was dominant regionally. METHODS: Subjects 
      were inpatients with COVID-19 who received infusion of sotrovimab in our 
      institute. In line with previous clinical trials, we included patients at risk of 
      COVID-19 worsening and SARS-CoV-2 vaccinees, who were hospitalized as directed by 
      the government. For statistical analyses, we reviewed background factors of 
      demographics, imaging, and laboratory findings for the outcome infusion-related 
      reactions including post-infusion pyrexia over 38 degrees Celsius and/or pulse 
      oximetry below 94%. RESULTS: In a total of 139 patients, the follow-up period had 
      a median of 200 days (range, 154-248 days). Among 119 patients (85.6%) fully 
      vaccinated for SARS-CoV-2, 86 (61.9% of all) underwent 2 doses while 33 (23.7% of 
      all) received 3 doses. For the outcome of pyrexia and/or dyspnea (N = 40, 28.8%), 
      multivariate analysis showed that significant risk factors were pre-infusion 
      lowered oximetry below 96.5% (Odds Ratio [OR] 0.344, 95% Confidence Interval [CI] 
      0.139-0.851, P = 0.021) and pre-infusion temperature more than 36.7 degrees 
      Celsius (OR 4.056, 95% CI 1.696-9.701, P = 0.002). Infusion-related reactions 
      included vomiting immediately after infusion, chill/shivering, dizziness, rash, 
      pruritus, pyrexia, and dyspnea. The number of patients with any of these events 
      was 44 (31.6%). Three patients (2.2%) showed worsening of COVID-19; one developed 
      hypoxia and two died. Limitations for this study included no genome typing 
      whether BA.1 or BA.2 lineage of the Omicron variant but the local epidemiology 
      indicated the prevalence of BA.1. Another was sotrovimab administration for 
      inpatients that allow precise detection of post-infusion events, confounding 
      previous exacerbation definition including hospitalization. CONCLUSIONS: For 24 h 
      after infusion of sotrovimab, COVID-19 patients showing pre-infusion lowered 
      oximetry below 96.5% and/or temperature more than 36.7 degrees Celsius may have 
      temperature elevation or dyspnea, warranting close monitoring for these risk 
      factors.
CI  - (c) 2022. The Author(s).
FAU - Yoshida, Junichi
AU  - Yoshida J
AUID- ORCID: 0000-0002-7183-8455
AD  - Infection Control Committee, Shimonoseki City Hospital, 1-13-1 Koyo-Cho, 
      Shimonoseki, 750-8520, Japan. yoshidaj@uicalumni.org.
FAU - Shiraishi, Kenichiro
AU  - Shiraishi K
AD  - Department of Medicine and Biosystemic Science, Kyushu University Faculty of 
      Medicine, 3-1-1 Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan.
FAU - Tanaka, Masao
AU  - Tanaka M
AD  - Infection Control Committee, Shimonoseki City Hospital, 1-13-1 Koyo-Cho, 
      Shimonoseki, 750-8520, Japan.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20221203
PL  - England
TA  - BMC Infect Dis
JT  - BMC infectious diseases
JID - 100968551
RN  - 1MTK0BPN8V (sotrovimab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - SARS-CoV-2 variants
SB  - IM
MH  - Humans
MH  - SARS-CoV-2
MH  - Inpatients
MH  - Retrospective Studies
MH  - Japan/epidemiology
MH  - Antibodies, Monoclonal, Humanized/adverse effects
MH  - Fever/etiology
MH  - Dyspnea
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - *COVID-19 Drug Treatment
PMC - PMC9719203
OTO - NOTNLM
OT  - Fever
OT  - Hypoxia
OT  - Infusion reaction
OT  - SARS-CoV-2
OT  - Sotrovimab
COIS- The authors declare that they have no competing interests.
EDAT- 2022/12/03 06:00
MHDA- 2022/12/07 06:00
PMCR- 2022/12/03
CRDT- 2022/12/02 23:47
PHST- 2022/03/28 00:00 [received]
PHST- 2022/11/21 00:00 [accepted]
PHST- 2022/12/02 23:47 [entrez]
PHST- 2022/12/03 06:00 [pubmed]
PHST- 2022/12/07 06:00 [medline]
PHST- 2022/12/03 00:00 [pmc-release]
AID - 10.1186/s12879-022-07889-z [pii]
AID - 7889 [pii]
AID - 10.1186/s12879-022-07889-z [doi]
PST - epublish
SO  - BMC Infect Dis. 2022 Dec 3;22(1):902. doi: 10.1186/s12879-022-07889-z.