Evidence map›Paper›PMID 40225829›Full record

ReviewOpen forum infectious diseases2025

A Rapid Systematic Review of U.S. Food and Drug Administration-Authorized COVID-19 Treatments.

Margaret A Maglione, Jeffrey D Klausner, Patricia K Wirnkar, Ivan Fallarme, Rozhin Lak, Kimny Sysawang, Ning Fu, Sachi Yagyu, Aneesa Motala, Danica Tolentino and 1 more

Abstract readReview
In one paragraph

Review in Open forum infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Response to Letter to the Editor RegardingOpen forum infectious diseases · 2025
    Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Margaret A MaglioneSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.ORCID https://orcid.org/0000-0001-9290-4119
Jeffrey D KlausnerSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.ORCID https://orcid.org/0000-0002-6922-7364
Patricia K WirnkarSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
Ivan FallarmeSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
Rozhin LakSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
Kimny SysawangSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
Ning FuSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.ORCID https://orcid.org/0000-0002-1791-367X
Sachi YagyuSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
Aneesa MotalaSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
Danica TolentinoSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.ORCID https://orcid.org/0000-0001-9625-2840
Susanne HempelSouthern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.ORCID https://orcid.org/0000-0003-1597-5110

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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).

Indexed as

adverse eventsconvalescent plasmaCOVID-19spike protein receptor-binding antibodiestocilizumab

Identifiers

PMID40225829
PMCPMC11986950

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.