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RECRUITING
NCT07197164
PHASE2

Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients

Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

View on ClinicalTrials.gov

Summary

Since the start of the COVID-19 pandemic, the approach to solid organ transplantation has evolved. Transplants using organs (excluding lungs) from COVID-19-positive donors have shown short-term safety, but there is limited data on recipients who are SARS-CoV-2 positive. Currently, kidney transplants in such recipients are delayed until symptoms resolve and a negative PCR is preferred, despite the risks of prolonged dialysis and increased cold ischemia time. Recent data from the Omicron era suggest that early antiviral treatment may reduce complications. Immunosuppressive therapy might even help mitigate severe inflammatory responses. The proposed study aims to show that kidney transplantation can be safely performed in asymptomatic or mildly symptomatic COVID-19-positive recipients who begin antiviral treatment (remdesivir) within 24 hours before transplant and continue for 10 days. This could reduce waiting times and improve outcomes. Remdesivir is an antiviral safe for use in patients with low kidney function, including those on dialysis or post-transplant, with minimal side effects. The hypothesis is that this treatment strategy can prevent progression to severe COVID-19 and allow safe transplantation

Official title: Safety and Efficacy of 10-day Course of Remdesivir to Prevent Severe COVID-19 in Asymptomatic or Paucisymptomatic SARS-COV-2-positive Kidney Transplant Recipients: a Single-arm Proof-of-concept Interventional Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-09-01

Completion Date

2027-02-28

Last Updated

2025-09-29

Healthy Volunteers

No

Interventions

DRUG

Remdesivir (RDV)

Participants will receive their first dose of remdesivir also within the 24 (+/-12) hours prior to going to the operating room. Remdesivir doses will be 200 mg on day 1, followed by 100 mg daily from days 2 to 10, for a total of 10 days.

Locations (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain