Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Aug 13;10(16):e36102.
doi: 10.1016/j.heliyon.2024.e36102. eCollection 2024 Aug 30.

Monoclonal antibodies against SARS-CoV-2 to prevent COVID-19 worsening in a large multicenter cohort

Alessandro Soria  1 , Francesca Graziano  2   3 , Giulia Ghilardi  1   4 , Giuseppe Lapadula  1   4 , Daniela Dalla Gasperina  5 , Simone Vasilij Benatti  6   7 , Eugenia Quiros-Roldan  8 , Maurizio Milesi  9 , Francesca Bai  7   10 , Marco Merli  11 , Davide Minisci  8   12 , Marco Franzetti  13 , Erika Asperges  14 , Filippo Chiabrando  15 , Daria Pocaterra  16 , Alessandro Pandolfo  17 , Fabio Zanini  18 , Domenico Lombardi  19 , Anna Cappelletti  1 , Alban Rugova  1 , Maria Lucia Borghesi  1 , Nicola Squillace  1 , Luigi Pusterla  19 , Stefania Piconi  17 , Paola Morelli  16 , Patrizia Rovere Querini  15   20 , Raffaele Bruno  14 , Stefano Rusconi  13   21 , Salvatore Casari  12 , Alessandra Bandera  22   23 , Fabio Franzetti  24 , Giovanna Travi  11 , Antonella D'Arminio Monforte  7   10 , Giulia Marchetti  7   10 , Angelo Pan  9 , Francesco Castelli  8 , Marco Rizzi  6 , Francesco Dentali  5 , Maria Mallardo  3 , Emanuela Rossi  3 , Maria Grazia Valsecchi  2   3 , Stefania Galimberti  2   3 , Paolo Bonfanti  1   4
Affiliations

Monoclonal antibodies against SARS-CoV-2 to prevent COVID-19 worsening in a large multicenter cohort

Alessandro Soria et al. Heliyon. .

Abstract

Objective: Monoclonal antibodies (mAbs) against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) reduced Coronavirus Disease 2019 (COVID-19) hospitalizations in people at risk of clinical worsening. Real-world descriptions are limited.

Methods: CONDIVIDIAMO, a two-year multicenter observational study, consecutively enrolled SARS-CoV-2 outpatients with ≥1 risk factor for COVID-19 progression receiving mAbs. Demographic data, underlying medical condition, type of mAbs combination received, duration of symptoms before mAbs administration, COVID-19 vaccination history, were collected upon enrolment and centrally recorded. Data on outcomes (hospitalizations, reasons of hospitalization, deaths) were prospectively collected. The primary endpoint was the rate of hospitalization or death in a 28-day follow-up, whichever occurred first; subjects were censored at the day of last follow-up or up to 28 days. The Kaplan-Meier method was used to estimate the incidence rate curve in time. The Cox regression model was used to assess potential risk factors for unfavorable outcome. Results were shown as hazard ratio (HR) along with the corresponding 95 % Confidence Interval (95%CI).

Results: Among 1534 subjects (median [interquartile range, IQR] age 66.5 [52.4-74.9] years, 693 [45.2 %] women), 632 (41.2 %) received bamlanivimab ± etesevimab, 209 (13.6 %) casirivimab/imdevimab, 586 (38.2 %) sotrovimab, 107 (7.0 %) tixagevimab/cilgavimab. After 28-day follow-up, 87/1534 (5.6 %, 95%CI: 4.4%-6.8 %) met the primary outcome (85 hospitalizations, 2 deaths). Hospitalizations for COVID-19 (52, 3.4 %) occurred earlier than for other reasons (33, 2.1 %), after a median (IQR) of 3.5 (1-7) versus 8 (3-15) days (p = 0.006) from mAbs administration.In a multivariable Cox regression model, factors independently associated with increased hospitalization risk were age (hazard ratio [HR] 1.02, 95%CI 1.00-1.03, p = 0.021), immunodeficiency (HR 1.78, 95%CI 1.11-2.85, p = 0.017), pre-Omicron calendar period (HR 1.66, 95%CI 1.02-2.69, p = 0.041).

Conclusions: MAbs real-world data over a 2-year changing pandemic landscape showed the feasibility of the intervention, although the hospitalization rate was not negligible. Immunosuppressed subjects remain more at risk of clinical worsening.

Keywords: COVID-19; Hospitalization; Immunodeficiency; Monoclonal antibodies; Omicron variant; SARS-CoV-2.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
(a) Cumulative incidence of composite outcome (hospitalization or death) within 28 days since the receipt of monoclonal antibodies (mAbs). (b) Cumulative incidence of hospitalization according to the reason (COVID-19 or other) within 28 days in patients receiving mAbs: hospital admissions for worsening of COVID-19 (grey line) occurred significantly earlier than those for non-COVID-19 reasons (black line). 30 patients with missing data for follow-up.
Fig. 2
Fig. 2
Results from Cox regression model on hospitalization (a) and on hospitalization for COVID-19, considering other reasons as competing risk (b). Legend: HR=Hazard Ratios; 95%CI = 95 % Confidence Intervals.
See this image and copyright information in PMC

References

    1. Gandhi R.T., Lynch J.B., Del Rio C. Mild or moderate covid-19. N. Engl. J. Med. 2020;383(18):1757–1766. - PubMed
    1. Berlin D.A., Gulick R.M., Martinez F.J. Severe covid-19. N. Engl. J. Med. 2020;383(25):2451–2460. - PubMed
    1. Dougan M., Nirula A., Azizad M., et al. Bamlanivimab plus etesevimab in mild or moderate covid-19. N. Engl. J. Med. 2021;385(15):1382–1392. - PMC - PubMed
    1. Weinreich D.M., Sivapalasingam S., Norton T., et al. REGEN-COV antibody combination and outcomes in outpatients with covid-19. N. Engl. J. Med. 2021;385(23) - PMC - PubMed
    1. Gupta A., Gonzalez-Rojas Y., Juarez E., et al. Early treatment for covid-19 with SARS-CoV-2 neutralizing antibody sotrovimab. N. Engl. J. Med. 2021;385(21):1941–1950. - PubMed