Actively Recruiting
Safety and Efficacy of 10-day Remdesivir to Prevent Severe COVID-19 in SARS-CoV-2 Positive Kidney Transplant Recipients
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
8 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
Researchers are evaluating a treatment approach for kidney transplant patients who test positive for COVID-19 but have no or mild symptoms. The study aims to assess whether starting antiviral therapy with remdesivir shortly before transplant and continuing for 10 days can prevent severe COVID-19 complications. This Phase 2 trial responds to evolving transplant practices during the pandemic and limited data on transplant safety in SARS-CoV-2 positive recipients. Participants will receive remdesivir, starting with a 200 mg dose within 24 (+/-12) hours before their transplant surgery, followed by 100 mg daily for 9 more days, totaling 10 days of treatment. The study includes patients with end-stage kidney disease scheduled for transplant who recently tested positive for SARS-CoV-2 and meet vaccination and symptom criteria. This single-arm trial focuses solely on remdesivir treatment without a comparison group. During the study, researchers will monitor participants for severe COVID-19 development up to 90 days after transplant. They will also track deaths, symptom resolution, hospital stay duration, viral clearance, treatment side effects, and graft complications at various time points. The total study participation includes follow-up visits and assessments extending to six months post-transplant to evaluate safety and treatment impact comprehensively.
CONDITIONS
Brief 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
- Have end-stage kidney disease and are on the local kidney transplant waiting list with 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 prior to transplant
- Received at least three COVID-19 vaccine doses with at least 3 months since last dose
- Asymptomatic or have mild COVID-19 symptoms within the past 5 days excluding fever over 38ºC in the last 48 hours or shortness of breath
- Female participants must be post-menopausal or agree to avoid pregnancy during the study using effective contraception if fertile
- Able to understand study information and provide informed consent
You will not qualify if you...
- Pregnant or breastfeeding women at enrollment
- Patients requiring supplemental oxygen or with severe COPD or pulmonary fibrosis
- Oxygen saturation below 94% on room air, respiratory rate over 30 breaths per minute, or new lung infiltrates on X-ray suggesting COVID-19 pneumonia
- Fever over 38ºC in last 48 hours or shortness of breath in previous 5 days
- History of allergy or contraindication to remdesivir
- ABO incompatible kidney transplant
- Use of desensitization therapy for high immunological risk or non-standard induction immunosuppression
- Active liver disease with elevated liver enzymes or impaired liver function
- Suspected or confirmed active respiratory infections other than COVID-19
- Recent hospitalization, surgery, or life-threatening conditions within specified time frames prior to study
- Previous participation in this trial
- Investigator site staff and their family members or sponsor employees involved in the study and their family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive remdesivir treatment to prevent severe COVID-19 following kidney transplantation.
Daily visits or dosing for 10 days
Duration - Up to 6 months
Participants are monitored for safety and effectiveness outcomes including COVID-19 symptoms, graft complications, and adverse events.
Visits at days 7, 14, 21, 28, 90, and 6 months post-transplant
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
C
Cristina Herrero Sánchez
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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