Evidence map›Paper›PMID 35895508›Full record

Trial reportThe Journal of infectious diseases2022

Casirivimab and Imdevimab for the Treatment of Hospitalized Patients With COVID-19.

Selin Somersan-Karakaya, Eleftherios Mylonakis, Vidya P Menon, Jason C Wells, Shazia Ali, Sumathi Sivapalasingam, Yiping Sun, Rafia Bhore, Jingning Mei, Jutta Miller and 24 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04426695 (A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike), which is not on this map. Cited by 33 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 5 pooled it
4.6field-weighted citation impact, top 4% of its field
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.

NCT04426695 phase1 / phase2completednot on this map

A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2020 to 2021Enrolled2,252ConditionsCOVID-19ArmsREGN10933+REGN10987 combination therapy, Placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 5 syntheses or guidelines pooled it, 46 citations in OpenAlex.

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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

34 authors at 4 institutions in 1 country.

Selin Somersan-KarakayaRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Eleftherios MylonakisDepartment of Medicine, Brown University, Providence, Rhode Island, USA.
Vidya P MenonNYC Health + Hospitals/Lincoln, The Bronx, New York, USA.
Jason C WellsThe Oregon Clinic, Portland, Oregon, USA.
Shazia AliRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Sumathi SivapalasingamRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Yiping SunRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Rafia BhoreRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Jingning MeiRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Jutta MillerRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Lisa CupelliRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Eduardo Forleo-NetoRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Andrea T HooperRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Jennifer D HamiltonRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Cynthia PanRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Viet PhamRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Yuming ZhaoRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Romana HosainRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Adnan MahmoodRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
John D DavisRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Kenneth C TurnerRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Yunji KimRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Amanda CookRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Bari KowalRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Yuhwen SooRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
A Thomas DiCioccioRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Gregory P GebaRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Neil StahlRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Leah LipsichRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Ned BraunsteinRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Gary A HermanRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
George D YancopoulosRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
David M WeinreichRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
COVID-19 Phase 2/3 Hospitalized Trial Team
Regeneron (United States) · USBrown University · USOregon Clinic · USThe Bronx Defenders · US

Funding

ASPR HHS HHSO100201700020C
6 · The paper itself

Abstract

backgroundThe open-label RECOVERY study reported improved survival in hospitalized, SARS-CoV-2 seronegative patients treated with casirivimab and imdevimab (CAS + IMD).

methodsIn this phase 1/2/3, double-blind, placebo-controlled trial conducted prior to widespread circulation of Delta and Omicron, hospitalized COVID-19 patients were randomized (1:1:1) to 2.4 g or 8.0 g CAS + IMD or placebo, and characterized at baseline for viral load and SARS-CoV-2 serostatus.

resultsIn total, 1336 patients on low-flow or no supplemental (low-flow/no) oxygen were treated. The primary endpoint was met in seronegative patients, the least-squares mean difference (CAS + IMD versus placebo) for time-weighted average change from baseline in viral load through day 7 was -0.28 log10 copies/mL (95% confidence interval [CI], -.51 to -.05; P = .0172). The primary clinical analysis of death or mechanical ventilation from day 6 to 29 in patients with high viral load had a strong positive trend but did not reach significance. CAS + IMD numerically reduced all-cause mortality in seronegative patients through day 29 (relative risk reduction, 55.6%; 95% CI, 24.2%-74.0%). No safety concerns were noted.

conclusionsIn hospitalized COVID-19 patients on low-flow/no oxygen, CAS + IMD reduced viral load and likely improves clinical outcomes in the overall population, with the benefit driven by seronegative patients, and no harm observed in seropositive patients. CLINICAL TRIALS REGISTRATION: NCT04426695.

Indexed as

COVID-19Antibodies, Monoclonal, HumanizedAntibodies, NeutralizingCOVID-19 Drug TreatmentDouble-Blind MethodDrug CombinationsHumansSARS-CoV-2Antibodies, Monoclonal, HumanizedAntibodies, Neutralizingcasirivimab and imdevimab drug combinationDrug CombinationscoronavirusCOVID-19hospitalizedmonoclonal antibodySARS-CoV-2

Identifiers

PMID35895508
PMCPMC9384575
OpenAlexW4288051721

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.