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NCT04414631

Conestat Alfa in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

Terminated Phase 2 Last updated 9 November 2021
What this trial tests

Phase 2 trial testing Conestat alfa in Coronavirus Infections in 80 participants. Terminated before completion.

Timeline
6 August 2020
Primary endpoint
15 September 2021
15 September 2021

Quick facts

Lead sponsorUniversity Hospital, Basel, Switzerland
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment80
Start date6 August 2020
Primary completion15 September 2021
Estimated completion15 September 2021
Sites5 locations across Switzerland, Brazil, Mexico

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Basel, Switzerland

Who can join

Adults 18 to 85, any sex, with Coronavirus Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to analyze if administration of conestat alfa for 72 hours in addition to standard of care (SOC) in patients hospitalized with non-critical SARS-CoV-2 pneumonia (WHO Ordinal Scale Score 3 or 4) reduces the risk of disease progression to Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Endothelial dysfunction and immunothrombosis as key pathogenic mechanisms in COVID-19.
    Bonaventura A, Vecchié A, Dagna L, Martinod K, et al · · 2021 · cited 738× · PMID 33824483 · DOI 10.1038/s41577-021-00536-9
  2. The state of complement in COVID-19.
    Afzali B, Noris M, Lambrecht BN, Kemper C. · · 2022 · cited 224× · PMID 34912108 · DOI 10.1038/s41577-021-00665-1
  3. COVID-19: A review of therapeutic strategies and vaccine candidates.
    Izda V, Jeffries MA, Sawalha AH. · · 2021 · cited 159× · PMID 33217545 · DOI 10.1016/j.clim.2020.108634
  4. The immune response to SARS-CoV-2 and COVID-19 immunopathology - Current perspectives.
    Boechat JL, Chora I, Morais A, Delgado L. · · 2021 · cited 139× · PMID 33867315 · DOI 10.1016/j.pulmoe.2021.03.008
  5. Treatment of COVID-19 With Conestat Alfa, a Regulator of the Complement, Contact Activation and Kallikrein-Kinin System.
    Urwyler P, Moser S, Charitos P, Heijnen IAFM, et al · · 2020 · cited 70× · PMID 32922409 · DOI 10.3389/fimmu.2020.02072
  6. Complement cascade in severe forms of COVID-19: Recent advances in therapy.
    Chouaki Benmansour N, Carvelli J, Vivier E. · · 2021 · cited 51× · PMID 33738806 · DOI 10.1002/eji.202048959
  7. The interplay between neutrophils, complement, and microthrombi in COVID-19.
    Zuo Y, Kanthi Y, Knight JS, Kim AHJ. · · 2021 · cited 35× · PMID 33526325 · DOI 10.1016/j.berh.2021.101661
  8. Complement Alternative and Mannose-Binding Lectin Pathway Activation Is Associated With COVID-19 Mortality.
    Defendi F, Leroy C, Epaulard O, Clavarino G, et al · · 2021 · cited 32× · PMID 34567008 · DOI 10.3389/fimmu.2021.742446

Verify or expand the search:

Other recruiting trials for Coronavirus Infections

Currently open trials in the same condition.

Other University Hospital, Basel, Switzerland trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04414631.

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