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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

About this trial

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

Eligibility criteria

Qualifiers

At least 18 years-old

Patients with end-stage kidney disease that are included on the local kidney transplant waiting list who get an offer of a compatible organ and, subsequently, have a transplant procedure scheduled in the next 24 (+/-) 12 hours, or patients with end-stage kidney disease that are planned to receive a non-cadaveric donor kidney transplant on the following 5 days.

Have a positive SARS-CoV-2 nasopharyngeal PCR or RAT within 5 days prior to transplant surgery.

Have previously received at least three SARS-CoV-2 vaccine doses, with a minimum time elapsed of 3 months since the last dose received.

Disqualifiers

Pregnant or breastfeeding women, at time of enrollment

Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis.

Patients having any of the following at the screening period: i) O2 saturation below 94% on room air; ii) respiratory frequency of > 30bpm; or iii) Xray showing new-onset pulmonary infiltrates suggesting COVID-19 pneumonia.

Patients having fever (>38ºC) in the last 48 hours or shortness of breath in the previous 5 days.

Trial design

Treatments tested in this trial

  • Remdesivir (RDV)

Treatment groups

15 Participants
are divided into 1 treatment group