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Safety and Effectiveness of a 10-Day Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients with Mild or No Symptoms: A Single-Group Trial
EU CTIS ID: 2024-519272-96-00
What this study is testing
To evaluate the clinical efficacy of administering antiviral treatment with IV remdesivir for 10 days in asymptomatic or paucisymptomatic kidney transplant recipients who are SARS-CoV-2-positive by nasopharyngeal PCR or RAT in the 5 days before the date of transplant.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Are asymptomatic or have mild acute COVID-19 symptoms during the previous 5 days (headache, sore throat, cough, chest pain, nausea, diarrhea, fatigue, loss of smell or taste, myalgia) excluding fever in the previous 48 hours (>38ºC) or shortness of breath.
- Having understood the information provided and capable of giving consent to participate in this trial by signing the Informed Consent document.
You likely can't join if
- Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis
- Participants who receive different types of induction immunosuppression other than the standard induction protocols with lymphocyte- depleting agents (thymoglobulin or basiliximab).
- Active liver disease with AST or ALT >3 ULN, Total bilirubin ≥2 × ULN (for Gilbert’s syndrome, direct bilirubin >ULN is exclusionary) within the past 3 months, or liver function impairment with Class B or C per Child Pugh classification
- Suspected or confirmed concurrent active respiratory infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- Pregnant or breastfeeding women, at time of enrollment
- Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
See the full eligibility criteria
Who can join
- 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.
- Are asymptomatic or have mild acute COVID-19 symptoms during the previous 5 days (headache, sore throat, cough, chest pain, nausea, diarrhea, fatigue, loss of smell or taste, myalgia) excluding fever in the previous 48 hours (>38ºC) or shortness of breath.
- Having understood the information provided and capable of giving consent to participate in this trial by signing the Informed Consent document.
- Post-menopausal or fertile females (females who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) that agree to avoid pregnancy during the study. If sexually active female; using highly effective contraceptive methods (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner*) while on study treatment. All female volunteers must be willing to undergo urine pregnancy tests at time of enrollment
What rules you out
- Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis
- Participants who receive different types of induction immunosuppression other than the standard induction protocols with lymphocyte- depleting agents (thymoglobulin or basiliximab).
- Active liver disease with AST or ALT >3 ULN, Total bilirubin ≥2 × ULN (for Gilbert’s syndrome, direct bilirubin >ULN is exclusionary) within the past 3 months, or liver function impairment with Class B or C per Child Pugh classification
- Suspected or confirmed concurrent active respiratory infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- Pregnant or breastfeeding women, at time of enrollment
- Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
- Prior participation in this trial.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- 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.
- Previous history of hypersensitivity, documented allergy or contraindications to receive remdesivir.
- ABO incompatible kidney transplant
- Desensitization therapy indicated as induction therapy for high immunological risk transplant with Donor Specific HLA Antibodies (DSA)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.