Evidence map›Paper›PMID 37965347›Full record

Trial reportFrontiers in immunology2023

Recombinant C1 inhibitor in the prevention of severe COVID-19: a randomized, open-label, multi-center phase IIa trial.

Pascal Urwyler, Marina Leimbacher, Panteleimon Charitos, Stephan Moser, Ingmar A F M Heijnen, Marten Trendelenburg, Reto Thoma, Johannes Sumer, Adrián Camacho-Ortiz, Marcelo R Bacci and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Frontiers in immunology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04414631 (Recombinant Human C1 Esterase Inhibitor), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.4field-weighted citation impact, top 16% 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.

NCT04414631 phase2terminatednot on this map

Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial (PROTECT-COVID-19).

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2020 to 2021Enrolled80ConditionsCoronavirus InfectionsArmsConestat alfa
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Therapeutic Potential of C1-Inhibitor in Vascular Diseases and Beyond.Arteriosclerosis, thrombosis, and vascular biology · 2026
    Review
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  3. Article
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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

15 authors at 7 institutions in 3 countries.

Pascal UrwylerDivision of Internal Medicine, University Hospital Basel, Basel, Switzerland.
Marina LeimbacherDivision of Internal Medicine, University Hospital Basel, Basel, Switzerland.
Panteleimon CharitosDivision of Internal Medicine, University Hospital Basel, Basel, Switzerland.
Stephan MoserDivision of Internal Medicine, University Hospital Basel, Basel, Switzerland.
Ingmar A F M HeijnenDivision of Medical Immunology, Laboratory Medicine, University Hospital Basel, Basel, Switzerland.
Marten TrendelenburgDivision of Internal Medicine, University Hospital Basel, Basel, Switzerland.
Reto ThomaDivision of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.
Johannes SumerDivision of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.
Adrián Camacho-OrtizServicio de Infectologia, Hospital Universitario Dr. José Eleuterio González, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Mexico.
Marcelo R BacciDepartment of General Practice, Centro Universitário em Saúde do ABC, Santo André, Brazil.
Lars C HuberClinic for Internal Medicine, City Hospital Triemli, Zurich, Switzerland.
Melina Stüssi-HelblingClinic for Internal Medicine, City Hospital Triemli, Zurich, Switzerland.
Werner C AlbrichDivision of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.
Parham SendiInstitute for Infectious Diseases, University of Bern, Bern, Switzerland.
Michael OsthoffDivision of Internal Medicine, University Hospital Basel, Basel, Switzerland.
University Hospital of Basel · CHUniversity of St. Gallen · CHTriemli Hospital · CHFaculdade de Medicina do ABC · BRHospital Universitario Dr José Eleuterio Gonzalez · MXUniversity of Basel · CHUniversity of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Conestat alfa (ConA), a recombinant human C1 inhibitor, may prevent thromboinflammation. Methods: We conducted a randomized, open-label, multi-national clinical trial in which hospitalized adults at risk for progression to severe COVID-19 were assigned in a 2:1 ratio to receive either 3 days of ConA plus standard of care (SOC) or SOC alone. Primary and secondary endpoints were day 7 disease severity on the WHO Ordinal Scale, time to clinical improvement within 14 days, and safety, respectively. Results: The trial was prematurely terminated because of futility after randomization of 84 patients, 56 in the ConA and 28 in the control arm. At baseline, higher WHO Ordinal Scale scores were more frequently observed in the ConA than in the control arm. On day 7, no relevant differences in the primary outcome were noted between the two arms ( Conclusion: The study results do not support the use of ConA to prevent COVID-19 progression. Clinical trial registration: https://clinicaltrials.gov, identifier NCT04414631.

Indexed as

COVID-19ThrombosisAdultEndothelial CellsHumansInflammationSARS-CoV-2C1 esterase inhibitorcomplement systemcontact activation systemCOVID-19kallikrein kinin systemrandomized trial

Identifiers

PMID37965347
PMCPMC10641758
OpenAlexW4388178470

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.