Article Impact Level: HIGH Data Quality: STRONG Summary of Open Forum Infectious Diseases, 12(4), ofaf097. https://doi.org/10.1093/ofid/ofaf097 Dr. Margaret A. Maglione et al.
Points
- This systematic review assessed the association of convalescent plasma, antivirals, and monoclonal antibodies with serious adverse events (SAEs) during the COVID-19 pandemic based on 54 studies, including 31 randomized controlled trials.
- The review found insufficient evidence linking antivirals or spike protein receptor-binding antibodies with SAEs, but tocilizumab was associated with higher risks of neutropenia and infection in hospitalized COVID-19 patients.
- Convalescent plasma was associated with thrombotic events and bleeding in patients with hematologic cancers and infection in other groups. However, the certainty of these findings was moderate for thrombotic events and limited for infection.
- The study noted that severe COVID-19 infection itself may cause significant health consequences, making it difficult to distinguish between the effects of treatments and the disease’s toxicity.
- The review concluded that while FDA-approved COVID-19 treatments are clinically indicated, healthcare providers should monitor for potential toxicities, particularly in high-risk patients with comorbidities, to ensure safe treatment practices.
Summary
This systematic review assessed the association of convalescent plasma, antivirals, and monoclonal antibodies with serious adverse events (SAEs) during the COVID-19 pandemic. Fifty-four studies, including 31 randomized controlled trials, were included in the analysis. Results indicated insufficient evidence linking antivirals or spike protein receptor-binding antibodies with SAEs. However, the monoclonal antibody tocilizumab, an interleukin-6 inhibitor, was associated with a higher risk of neutropenia and infection in hospitalized COVID-19 patients. However, the certainty of these findings was moderate for neutropenia and limited for infection. Furthermore, convalescent plasma showed a potential association with thrombotic events and bleeding in patients with hematologic cancers, with moderate certainty, and infection in other groups, with limited certainty.
The review found that while severe COVID-19 infection itself may lead to significant health consequences, it is often difficult to differentiate these from the toxicities of the treatments administered. No significant safety concerns were identified for antivirals or spike protein receptor-binding antibodies. However, specific treatments, such as tocilizumab and convalescent plasma, could be associated with specific risks, particularly in high-risk populations. These findings underscore the importance of monitoring and careful prescription of COVID-19 treatments, especially in patients with comorbid conditions who are more susceptible to adverse effects.
In conclusion, while FDA-approved treatments for COVID-19 are clinically indicated, clinical practice requires continued vigilance to detect rare and potentially significant toxicities. Healthcare providers should remain alert to the possible risks associated with these interventions, especially when managing patients with specific risk factors or comorbidities.
Link to the article: https://academic.oup.com/ofid/article/12/4/ofaf097/8105792
References Maglione, M. A., Klausner, J. D., Wirnkar, P. K., Fallarme, I., Lak, R., Sysawang, K., Fu, N., Yagyu, S., Motala, A., Tolentino, D., & Hempel, S. (2025). A rapid systematic review of u. S. Food and drug administration-authorized covid-19 treatments. Open Forum Infectious Diseases, 12(4), ofaf097. https://doi.org/10.1093/ofid/ofaf097
