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. 2022 Aug 18;10(8):2002.
doi: 10.3390/biomedicines10082002.

Safety Profile and Outcomes of Early COVID-19 Treatments in Immunocompromised Patients: A Single-Centre Cohort Study

Simona Biscarini  1 , Simone Villa  2 , Camilla Genovese  1   2   3 , Mara Tomasello  1   2   3 , Anna Tonizzo  1   2   3 , Marco Fava  1   2   3 , Nathalie Iannotti  1 , Matteo Bolis  1 , Bianca Mariani  1 , Antonia Grazia Valzano  4 , Letizia Corinna Morlacchi  5 , Francesca Donato  6 , Giuseppe Castellano  7 , Ramona Cassin  8 , Maria Carrabba  9 , Antonio Muscatello  1 , Andrea Gori  1   2   3 , Alessandra Bandera  1   2   3 , Andrea Lombardi  1   2   3
Affiliations

Safety Profile and Outcomes of Early COVID-19 Treatments in Immunocompromised Patients: A Single-Centre Cohort Study

Simona Biscarini et al. Biomedicines. .

Abstract

Background: Early treatment with remdesivir (RMD) or monoclonal antibodies (mAbs) could be a valuable tool in patients at risk of severe COVID-19 with unsatisfactory responses to vaccination. We aim to assess the safety and clinical outcomes of these treatments among immunocompromised subjects.

Methods: We retrospectively reviewed all nonhospitalized patients who received an early treatment with RMD or mAbs for COVID-19, from 25 November 2021 to 25 January 2022, in a large tertiary hospital. Outcomes included frequency of adverse drug reaction (ADR), duration of symptoms and molecular swab positivity, emergency department access, hospital or intensive care unit admission, and mortality in the 14 days following treatment administration.

Results: Early treatments were administered to 143 patients, 106/143 (74.1%) immunocompromised, including 41 solid organ and 6 hematopoietic stem cell transplant recipients. Overall, 23/143 (16.1%) subjects reported ADRs. Median time from treatment start to SARS-CoV-2 nasopharyngeal swab negativity and symptom resolution was 10 (IQR 6-16) and 2.5 days (IQR 1.0-6.0), respectively, without differences between immunocompromised and nonimmunocompromised patients. In the 14 days after treatment administration, 5/143 patients (3.5%) were hospitalized and one died as a result of causes related to COVID-19, all of them were immunocompromised.

Conclusions: RMD and mAbs have minimal ADRs and favourable outcomes in immunocompromised patients.

Keywords: COVID-19; early treatments; monoclonal antibodies; remdesivir; sotrovimab.

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Conflict of interest statement

A.L. Gilead Sciences Inc. and Insmed Italia. A.B. Quiagen, Pfizer, Nordic Pharma, ViiV, SOBI, and Gilead Sciences. F.D. Kedrion, Gilead Sciences, Biotest, and Novartis. A.M. Gilead Sciences, Menarini, and Nordic Pharma. S.B. Infectopharma. M.C. Takeda and Kedrion. All the other authors have nothing to declare.

Figures

Figure 1
Figure 1
Study flowchart.
See this image and copyright information in PMC

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