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
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.
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.
Single group
Remdesivir (RDV)
DrugParticipants 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.
Number and proportion of participants who develop severe COVID-19 following kidney transplantation
Primary estimates: Severe SARS-CoV-2 will be defined as: Hypoxemia (O2 sat \<94%), one or more compatible respiratory symptoms (fever, dyspnea, increased respiratory frequency \> 22, cough) AND new radiologic infiltrates compatible with COVID-19 in a chest X Ray, chest CT or ultrasound.
Number of deaths (all causes mortality) at days 28 and 90 post-transplant
the cumulative mortality at days 28 and 90 after transplant in asymptomatic or paucisymptomatic SARS-CoV-2-positive kidney transplant recipients receiving a 10-day course of remdesivir
Time (days) to resolution and to recovery of all targeted symptoms through Day 28 and Day 90
Duration of targeted COVID-19 symptoms (COVID-19 Questionnaire).
Proportion of participants requiring extension of the hospitalization beyond POD10 (all cause and related to COVID-19)
% participants with COVID complications at the hospitalization that requires invasive Mechanical ventilation, intensive care unit (ICU) stayed or extension of the hospitalization related to COVID-19
Proportion of participants with symptomatic rebound through day 28.
% participant who, after an initial improvement or resolution of symptoms, experience a recurrence of symptoms within the 28-day follow-up period
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