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5PSQ-088 Anti SARS-CoV-2 monoclonal antibodies: from clinical trial to real-world evidence
  1. M Brachet Cota1,
  2. A Ucciero2,
  3. L Lanzone3,
  4. M Massa4,
  5. S Bonetta5,
  6. D Brustia6,
  7. A Barco6,
  8. A Pisterna2
  1. 1Scuola di Specializzazione in Farmacia Ospedaliera Novara, Scienze del Farmaco – Novara, Novara, Italy
  2. 2AOU Maggiore della Carità di Novara, SC Farmacia, Novara, Italy
  3. 3ASL Biella, Soc Farmacia, Biella, Italy
  4. 4ASL Vercelli, SC Farmacia, Vercelli, Italy
  5. 5ASL VCO, SC Farmacia, Verbania, Italy
  6. 6AOU Maggiore della Carità di Novara, SCDU Malattie Infettive, Novara, Italy


Background and importance Monoclonal antibodies (mAbs) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were recently shown to be promising in preventing hospitalisation and death among patients with mild to moderate COVID-19 symptoms in randomised controlled trials. These medicines are subject to additional monitoring and, in our country, this occurs through the Italian Medicine Agency (AIFA). They have been authorised in subjects >12 years, positive for SARS-CoV-2, not hospitalised for COVID-19, not on oxygen therapy, with mild to moderate symptoms of recent onset at high risk of progression into severe disease. In the absence of solid safety and efficacy data, regulatory bodies recommend infusion in a hospital/protected setting. To our knowledge, limited data are available on real-life use of mAbs.

Aim and objectives The aim of the work was to evaluate the risk of a hospitalisation or death in patients using these medications and the occurrence of side effects.

Material and methods Clinical data of SARS-Cov-2 patients that initiated mAb infusions supplied by our SC Pharmacy, Eastern Piedmont Storage Hub Centres (serving over 1 million inhabitants), were retrospectively collected during the March–August 2021 period. The primary endpoint was a composite of COVID-19-related hospitalisation or death at day 28.

Results The population included 85 patients; median age 68 years (80% male); 18 positive due to nosocomial infection; main comorbidities were cardiovascular and onco-haematological diseases (33%–16%). The proportion of patients with COVID-19-related hospitalisation at 28 days was 16% (14 events). There were a total of 9 deaths. The mean time between mAb therapy and reverse transcription-polymerase chain reaction (RT-PCR) negative nasopharyngeal swab test was 19 days. AEs were observed in only 3 patients (hypotension, dyspnoea, chills, fever).

Conclusion and relevance Our results were consistent with recent results showing a reduced risk of hospitalisation or death in outpatients with mild-to-moderate COVID-19. Multidisciplinary dialogue between the pharmacist, virologist and general practitioner showed the need to define homogenous methodologies for collection of clinical data in the real-world context (ie, nasopharyngeal swab test execution data). Further real-world studies are needed to validate these findings.

Conflict of interest No conflict of interest

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