Trial intelligence / Profile preview

Remdesivir for Long-COVID Prevention in Hospitalized Patients

NCT04978259Phase 4

Key facts

Status
Unknown
Start
Jul 2021
Primary completion
Feb 2023
Countries
1
Sponsor
Clinical Urology and Epidemiology Working Group
Modality
Orthosteric Ligands, Metabolically Activated Prodrugs
Conditions
coronavirus disease 2019 (COVID-19)
01

Overview

Phase 4, randomised, open-label trial in coronavirus disease 2019 (COVID-19) comparing Standard of care plus remdesivir with Standard of care (2 arms). Primary endpoints: EuroQol Visual Analogue Scale at 1 year, EuroQol 5-Dimension 5-Level at 1 year and 4 more. Status: unknown.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Standard of care plus remdesivir

    Local standard of care plus daily remdesivir infusion for up to 10 days.

  • Standard of care

    Local standard of care alone.

03

Who it enrols

Adults hospitalized with laboratory-confirmed SARS-CoV-2 infection, excluding those with severe renal or liver impairment, pregnancy, or life expectancy < 3 months.

04

Endpoints

Primary

  • EuroQol Visual Analogue Scale

  • EuroQol 5-Dimension 5-Level

  • Recovery from COVID-19 Infection

  • Fatigue

  • Exertional dyspnea

Secondary

  • EuroQol Visual Analogue Scale at 2 years

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