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Study of Remdesivir to Prevent Severe COVID-19 in Kidney Transplant Recipients with No or Mild Symptoms

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study focuses on preventing severe COVID-19 in kidney transplant recipients who have tested positive for SARS-CoV-2 but have no symptoms or only mild symptoms. The study will use remdesivir, an antiviral medication that is given through an intravenous infusion. Remdesivir is already approved for treating COVID-19 and will be administered over a 10-day period.

The purpose of this research is to evaluate how well remdesivir works in protecting kidney transplant patients from developing severe COVID-19 after their transplant surgery. These patients are particularly vulnerable to complications from COVID-19 because their immune system needs to be suppressed to prevent organ rejection. The medication will be given to patients who have received at least three COVID-19 vaccine doses and have tested positive for the virus within 5 days before their scheduled kidney transplant.

During the study, patients will receive remdesivir through an intravenous line for 10 days. The total amount of medication will not exceed 1100 mg, with a maximum daily dose of 200 mg. Patients will be monitored for 90 days after their transplant to check how well the treatment works and to watch for any side effects. The study will look at whether patients develop severe COVID-19 symptoms, such as breathing difficulties or chest abnormalities visible on imaging tests.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening
You will be screened for eligibility after testing positive for SARS-CoV-2 within 5 days before your scheduled kidney transplant
Your symptoms must be either absent or mild (such as headache, sore throat, cough, without fever above 38°C or breathing difficulties)
You must have received at least three doses of COVID-19 vaccine, with the last dose given at least 3 months ago
Step 2
Treatment initiation
You will receive Veklury (remdesivir) through an intravenous infusion
The treatment consists of 100 mg doses given daily
The treatment course lasts for 10 days
Step 3
Monitoring during treatment
Your COVID-19 symptoms will be monitored throughout the treatment period
Regular tests will check for the presence of the virus in your system
Your kidney function will be monitored
Blood tests will be performed to check your liver function
Step 4
Follow-up period
You will be monitored for 90 days after your transplant
Virus tests will be performed on days 5, 10, 14, 21, and 28 after the procedure
Your overall health status will be evaluated regularly
Any symptoms or side effects will be documented
Step 5
Final assessment
A final evaluation will be conducted at day 90
Your overall recovery and kidney function will be assessed
Any complications or health issues that occurred during the study period will be documented

Who can join the trial?

7 criteria

Must be at least 18 years old
Must be a patient with end-stage kidney disease (severe kidney failure requiring dialysis or transplant) who is either: - On a kidney transplant waiting list with a scheduled transplant in the next 12-36 hours, or - Scheduled to receive a living donor kidney transplant within 5 days
Must have tested positive for SARS-CoV-2 (the virus that causes COVID-19) through a nose swab test within 5 days before transplant
Must have received at least three COVID-19 vaccine doses, with the last dose given at least 3 months ago
Must be either: - Without symptoms, or - Having only mild COVID-19 symptoms in the past 5 days (such as headache, sore throat, cough, chest pain, nausea, diarrhea, fatigue, loss of smell or taste, muscle pain) - Must not have had fever above 38°C (100.4°F) in the past 48 hours - Must not have shortness of breath
Must be able to understand the study information and sign the consent form
For women participants: - Must be post-menopausal (no menstrual periods for over 12 months), or - If able to become pregnant, must agree to use effective birth control methods (hormonal contraception or IUD) during the study - Must be willing to take pregnancy tests at the start of the study

Who cannot join the trial?

14 criteria

Patients with severe COVID-19 symptoms requiring hospitalization
Individuals who had previous kidney transplant rejection
Patients with known allergies to remdesivir or any components of the medication
Patients under 18 years of age
Pregnant or breastfeeding women
Patients with severe liver dysfunction (problems with liver function)
Individuals with estimated glomerular filtration rate (kidney function measure) below 30 mL/min
Patients currently participating in other clinical trials
Individuals unable to provide informed consent
Patients who tested positive for COVID-19 more than 5 days before transplant
Patients with significant heart conditions or unstable heart disease
Individuals with active cancer or ongoing cancer treatment
Patients with known drug resistance to antiviral medications
People with severe mental illness that could affect their ability to follow study procedures

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain
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Fundacio Puigvert
Barcelona, Spain
Verified
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
Badalona, Spain

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Investigated drugs

Remdesivir is an antiviral medication given through an intravenous (IV) infusion directly into the bloodstream. It works by stopping the virus that causes COVID-19 from spreading in the body. This medication is used to treat COVID-19 infection, particularly in cases where patients might be at risk of developing severe symptoms. In this trial, it is being studied as a preventive treatment for kidney transplant recipients who have tested positive for SARS-CoV-2 but have no symptoms or only mild symptoms.

Remdesivir

What is already known about the treatment

Remdesivir - An antiviral medication administered intravenously that has been specifically developed to combat viral infections, including COVID-19. This broad-spectrum antiviral works by interfering with the virus's ability to replicate its genetic material, effectively stopping the spread of the virus within the body's cells. Initially developed for treating Ebola virus infections, it gained prominence during the COVID-19 pandemic and has been authorized for treating SARS-CoV-2 infections, particularly in hospitalized patients and immunocompromised individuals such as transplant recipients. The drug belongs to the nucleotide analog class of medications and is typically administered through intravenous infusion over a multi-day course of treatment, with standard protocols often lasting 10 days.

Investigated diseases

COVID-19 – A respiratory illness caused by the SARS-CoV-2 virus that primarily affects the lungs and respiratory system. The infection can range from asymptomatic to symptomatic cases, where common symptoms include fever, cough, shortness of breath, and fatigue. The virus spreads mainly through respiratory droplets when infected people breathe, talk, cough, or sneeze. The disease can affect multiple organ systems in the body, including the respiratory, cardiovascular, and immune systems. The severity of symptoms can vary greatly among individuals, with some experiencing mild cold-like symptoms while others may develop respiratory difficulties.