Trial intelligence / Profile preview

Remdesivir to Prevent Severe COVID-19 in Kidney Transplant Recipients

NCT07197164Phase 2

Key facts

Status
Recruiting
Start
Sep 2025
Primary completion
Dec 2026
Countries
1
Modality
Orthosteric Ligands, Metabolically Activated Prodrugs
Conditions
coronavirus disease 2019 (COVID-19)
01

Overview

Phase 2, open-label, single-arm trial of remdesivir in coronavirus disease 2019 (COVID-19). Primary endpoint: Number and proportion of participants who develop severe COVID-19 following kidney transplantation at 90 days. Started Sep 2025; status: recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Single Arm

    Participants receive Remdesivir for 10 days starting 24h before transplant.

03

Who it enrols

Adult patients with end-stage kidney disease on the transplant waiting list who have a positive SARS-CoV-2 test within 5 days prior to transplant, are asymptomatic or mild, and have received at least 3 vaccine doses.

04

Endpoints

Primary

  • Number and proportion of participants who develop severe COVID-19 following kidney transplantation

Secondary

  • Number of deaths (all causes mortality)

  • Time to resolution and to recovery of all targeted symptoms

  • Proportion of participants requiring extension of the hospitalization beyond POD10

  • Proportion of participants with symptomatic rebound

  • Clearance kinetics of SARS-CoV-2 infection

  • Number of Participants with Treatment-Related Adverse Events

  • Incidence of graft complications

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