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5PSQ-078 Analysis of casirivimab and imdevimab use in outpatients with covid-19
  1. P Rozsívalová1,2,
  2. J Minaříková2,
  3. M Mikešová1,
  4. L Beková1,
  5. Ľ Slimáková3,
  6. A Štricová4,
  7. E Zimčíková2,
  8. M Heislerová1,
  9. P Šmahel5,
  10. J Malý2,
  11. V Koblížek6
  1. 1University Hospital Hradec Králové, Hospital Pharmacy, Hradec Kralove, Czech Republic
  2. 2Faculty of Pharmacy In Hradec Králové- Charles University, Department of Social and Clinical Pharmacy, Hradec Králové, Czech Republic
  3. 3University Hospital Bratislava, Hospital Pharmacy, Bratislava, Slovakia
  4. 4University Hospital Banská Bystrica, Hospital Pharmacy, Banská Bystrica, Slovakia
  5. 5University Hospital Hradec Králové, Department of Infectious Diseases, Hradec Kralove, Czech Republic
  6. 6University Hospital Hradec Králové, Department of Pulmonary Medicine, Hradec Kralove, Czech Republic


Background and Importance At height of COVID-19 pandemic surge of delta variant, monoclonal antibodies became a vital treatment option for SARS-COV-2 positive outpatients at high risk of severe disease progression. Casirivimab and imdevimab (C/I) were used under EMA emergency use authorisation (EUA) and there was paucity of real-world data on safety and effectiveness.

Aim and Objectives The study aimed to describe drug safety, self-reported symptom burden and vaccination status in SARS-COV-2 positive outpatients within 90 days post-C/I infusion.

Material and Methods Prospective multicentric survey of SARS-CoV-2 positive outpatients with mild symptoms at high-risk of severe COVID-19 progression (defined criteria under EUA authorisation for C/I ambulatory administration) was conducted from September 2021 till January 2022 in three teaching hospitals. The data collected using electronic medical records comprised: patient details, vaccination status, date of SARS-COV-2 positive test, indication, adverse drug reaction to infusion, hospitalisation. Structured telephone questionnaire with symptom scoring adapted from BLAZE-1 trial was used on D (day) 0, D+7, D+29 and D+90 post- C/I infusion. Data were analysed using MS Excel. Ethics committee approval was obtained.

Results Within studied period 404 out of 471 patients were included (median age 66 years; 57.4% females). Excluded patients included prophylactic C/I, not consented or dropped out. 396 patients had the first COVID-19 episode. The most frequent indications included age over 65 years (55.5%), hypertension (56.8%), diabetes mellitus II (19.4%). C/I infusion was administered with a mean of 2.3 days (range 0–11 days) since virus positivity. 62.4% patients had complete vaccination (2 or 3 doses Comirnaty, 1 dose Janssen vaccine) prior C/I infusion. Adverse events were reported by 11.6% of patients, most commonly chills, fever, diarrhea. Subjective worsening of symptoms after C/I infusion was reported by 3.4% subjects by D+7. 11.6% patients observed no difference in symptom score between D0 and D+7. Altogether 85%; 92% and 93.6% patients reported improvement in symptom burden score by D+7, D+29 and D+90 respectively.

Conclusion and Relevance We describe real-life outpatient utilisation of C/I in terms of patient characteristics, self-reported symptom burden and adverse events. Therapeutic value of C/I timely administration is evident in high-risk patients with completed vaccination.

References and/or Acknowledgements 1. N Engl J Med. 2021 Jan 21;384(3):229-237

Conflict of Interest No conflict of interest

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