Actively Recruiting
Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients
Led by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Updated on 2025-09-29
15
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
F
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Patients with end-stage kidney disease on the local kidney transplant waiting list who have a scheduled transplant within 24 (+/-) 12 hours or planned to receive a non-cadaveric donor kidney transplant within 5 days
- Positive SARS-CoV-2 nasopharyngeal PCR or rapid antigen test within 5 days before transplant surgery
- Received at least three doses of SARS-CoV-2 vaccine, with at least 3 months since the last dose
- Asymptomatic or mild COVID-19 symptoms in the last 5 days, excluding fever over 38ºC in the last 48 hours or shortness of breath
- Female participants who are post-menopausal or fertile agree to avoid pregnancy during the study and use effective contraception if sexually active
- Ability to understand information and provide informed consent
You will not qualify if you...
- Pregnant or breastfeeding women at the time of enrollment
- Patients requiring supplemental oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis
- Oxygen saturation below 94% on room air, respiratory rate over 30 breaths per minute, or new pulmonary infiltrates on X-ray suggesting COVID-19 pneumonia
- Fever over 38ºC in the last 48 hours or shortness of breath in the previous 5 days
- History of allergy or contraindications to remdesivir
- ABO incompatible kidney transplant
- Indication for desensitization therapy due to high immunological risk
- Use of induction immunosuppression other than standard protocols with lymphocyte-depleting agents
- Active liver disease with abnormal liver function tests or liver impairment classified as Child Pugh B or C within the past 3 months
- Suspected or confirmed active respiratory infection other than COVID-19
- Comorbidity requiring hospitalization or surgery within 7 days prior or considered life-threatening within 30 days prior to study entry
- Prior participation in this trial
- Investigator site staff involved in the study and their family members, sponsor employees involved in the study and their family members
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
Research Team
A
Alba Romero Caballero, MD, MSc
CONTACT
C
Cristina Herrero Sánchez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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