tetano
Editor, Senior Moderator
Open Forum Infect Dis
. 2025 Apr 11;12(4)
faf097.
doi: 10.1093/ofid/ofaf097. eCollection 2025 Apr. A Rapid Systematic Review of U.S. Food and Drug Administration-Authorized COVID-19 Treatments
Margaret A Maglione[SUP] 1 [/SUP], Jeffrey D Klausner[SUP] 1 [/SUP], Patricia K Wirnkar[SUP] 1 [/SUP], Ivan Fallarme[SUP] 1 [/SUP], Rozhin Lak[SUP] 1 [/SUP], Kimny Sysawang[SUP] 1 [/SUP], Ning Fu[SUP] 1 [/SUP], Sachi Yagyu[SUP] 1 [/SUP], Aneesa Motala[SUP] 1 [/SUP], Danica Tolentino[SUP] 1 [/SUP], Susanne Hempel[SUP] 1 [/SUP]
Affiliations
Background: The coronavirus disease 2019 (COVID-19) pandemic era saw numerous treatments authorized for emergency use by the United States (US) Food and Drug Administration (FDA). The purpose of the review was to determine if convalescent plasma, antivirals, or monoclonal antibodies are associated with serious adverse events (SAEs) and, if so, which specific populations are at risk.
Methods: PubMed, ClinicalTrials.gov, and the FDA submission database were searched through December 2023, and the Infectious Diseases Society of America guidelines, international COVID Network Meta-analysis database, and systematic reviews were reference mined to identify controlled studies with at least 1 US site. Reviewers abstracted study characteristics, number of patients experiencing each type of SAE, and methods of adverse event collection and reporting.
Results: Fifty-four studies met inclusion criteria, including 31 randomized controlled trials. We found insufficient evidence of association of any SAE with antivirals and spike protein receptor-binding antibodies. In patients hospitalized with COVID-19, the monoclonal antibody tocilizumab, an interleukin 6 inhibitor, may be associated with elevated risk of neutropenia (moderate certainty) and infection (limited certainty). Convalescent plasma may be associated with thrombotic events (limited certainty) as well as bleeding events and infection in patients with hematologic cancers (moderate certainty). Inclusion of studies without a US site could potentially change the findings.
Conclusions: Severe COVID-19 infection may have serious consequences, especially in hospitalized patients with comorbidities. These consequences may be confused with toxicities of the interventions. Based on our analysis, approved treatments for COVID-19 should be prescribed as clinically indicated, although continued vigilance is warranted to identify rare and potentially significant toxicities that may arise in clinical practice.
Clinical trials registration: PROSPERO (CRD42023467821).
Keywords: COVID-19; adverse events; convalescent plasma; spike protein receptor-binding antibodies; tocilizumab.
. 2025 Apr 11;12(4)
faf097.doi: 10.1093/ofid/ofaf097. eCollection 2025 Apr. A Rapid Systematic Review of U.S. Food and Drug Administration-Authorized COVID-19 Treatments
Margaret A Maglione[SUP] 1 [/SUP], Jeffrey D Klausner[SUP] 1 [/SUP], Patricia K Wirnkar[SUP] 1 [/SUP], Ivan Fallarme[SUP] 1 [/SUP], Rozhin Lak[SUP] 1 [/SUP], Kimny Sysawang[SUP] 1 [/SUP], Ning Fu[SUP] 1 [/SUP], Sachi Yagyu[SUP] 1 [/SUP], Aneesa Motala[SUP] 1 [/SUP], Danica Tolentino[SUP] 1 [/SUP], Susanne Hempel[SUP] 1 [/SUP]
Affiliations
- PMID: 40225829
- PMCID: PMC11986950
- DOI: 10.1093/ofid/ofaf097
Background: The coronavirus disease 2019 (COVID-19) pandemic era saw numerous treatments authorized for emergency use by the United States (US) Food and Drug Administration (FDA). The purpose of the review was to determine if convalescent plasma, antivirals, or monoclonal antibodies are associated with serious adverse events (SAEs) and, if so, which specific populations are at risk.
Methods: PubMed, ClinicalTrials.gov, and the FDA submission database were searched through December 2023, and the Infectious Diseases Society of America guidelines, international COVID Network Meta-analysis database, and systematic reviews were reference mined to identify controlled studies with at least 1 US site. Reviewers abstracted study characteristics, number of patients experiencing each type of SAE, and methods of adverse event collection and reporting.
Results: Fifty-four studies met inclusion criteria, including 31 randomized controlled trials. We found insufficient evidence of association of any SAE with antivirals and spike protein receptor-binding antibodies. In patients hospitalized with COVID-19, the monoclonal antibody tocilizumab, an interleukin 6 inhibitor, may be associated with elevated risk of neutropenia (moderate certainty) and infection (limited certainty). Convalescent plasma may be associated with thrombotic events (limited certainty) as well as bleeding events and infection in patients with hematologic cancers (moderate certainty). Inclusion of studies without a US site could potentially change the findings.
Conclusions: Severe COVID-19 infection may have serious consequences, especially in hospitalized patients with comorbidities. These consequences may be confused with toxicities of the interventions. Based on our analysis, approved treatments for COVID-19 should be prescribed as clinically indicated, although continued vigilance is warranted to identify rare and potentially significant toxicities that may arise in clinical practice.
Clinical trials registration: PROSPERO (CRD42023467821).
Keywords: COVID-19; adverse events; convalescent plasma; spike protein receptor-binding antibodies; tocilizumab.