Evidence map›Paper›PMID 34971385›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Compassionate Use of REGEN-COV® in Patients With Coronavirus Disease 2019 (COVID-19) and Immunodeficiency-Associated Antibody Disorders.

David Stein, Ernesto Oviedo-Orta, Wendy A Kampman, Jennifer McGinniss, George Betts, Margaret McDermott, Beth Holly, Johnathan M Lancaster, Ned Braunstein, George D Yancopoulos and 1 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.7field-weighted citation impact, top 26% 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.

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

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
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  7. Omicron Variant Escapes Therapeutic Monoclonal Antibodies (mAbs) Including Recently Released Evusheld®, Contrary to 8 Prior Main Variant of Concern (VOC).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
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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

11 authors at 1 institution in 1 country.

David SteinRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Ernesto Oviedo-OrtaRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Wendy A KampmanRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Jennifer McGinnissRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
George BettsRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Margaret McDermottRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Beth HollyRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Johnathan M LancasterRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Ned BraunsteinRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
George D YancopoulosRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
David M WeinreichRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Regeneron (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with immunodeficiency-associated antibody disorders are at a higher risk of prolonged/persistent COVID-19 infection, having no viable treatment options.

methodsA retrospective analysis of patients with primary and/or secondary immunodeficiency-associated antibody disorders who received casirivimab and imdevimab (REGEN-COV®) under emergency compassionate use. Objective were to describe safety and response to REGEN-COV, focusing on the subset of patients who had COVID-19 duration ≥21 days before treatment.

resultsQuantitative (change in oxygenation status and/or viral load) and/or qualitative (physician-reported clinical status) outcomes data are reported from 64 patients. Improvement in ≥1 outcome was observed in 90.6% of the overall patient group. Thirty-seven of these had COVID-19 duration ≥21 days before treatment; median time from diagnosis to REGEN-COV treatment was 60.5 days. Of the 29 patients with COVID-19 duration ≥21 days before treatment and available outcome data, 96.6% showed improvement in ≥1 outcome. In the 14 patients with post-treatment reverse transcription-polymerase chain reaction (RT-PCR) results available, 11 (78.6%) reported a negative RT-PCR following treatment, with 5 (45.5%) and 8 (72.7%) patients reporting a negative RT-PCR within 5 days and 21 days of treatment, respectively. Ten of 85 patients (11.8%) experienced serious adverse events; only one was an infusion-related reaction, possibly related to REGEN-COV. Two deaths were reported; neither were attributed to REGEN-COV.

conclusionsIn this retrospective analysis of immunodeficient patients granted REGEN-COV under emergency compassionate use, REGEN-COV treatment was associated with rapid viral clearance and clinical improvement in patients with longstanding COVID-19. Adverse events were consistent with COVID-19 and its associated complications, and due to patients' concurrent medical conditions.

Indexed as

COVID-19 Drug TreatmentAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingCompassionate Use TrialsDrug CombinationsHumansRetrospective StudiesSARS-CoV-2Antibodies, Monoclonal, HumanizedAntibodies, Neutralizingcasirivimabcasirivimab and imdevimab drug combinationDrug Combinationsimdevimabantibody deficiencyB-cell deficiencycompassionate useCOVID-19monoclonal antibody

Identifiers

PMID34971385
PMCPMC8755381
OpenAlexW4226314929

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.