Remdesivir for Kidney Transplant Patients with COVID-19
Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients
Recruiting
Phase 2Interventional Study
COVID - 19Renal TransplantSARS CoV 2 Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Other
Who this trial is looking for
This trial is looking for kidney transplant patients who have mild or no COVID-19 symptoms. Participants will receive remdesivir before their transplant to help prevent serious illness and improve safety during the surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I am on the kidney transplant waiting list.
I tested positive for COVID-19 within the last 5 days.
I have received at least three doses of the COVID-19 vaccine.
I have mild or no symptoms of COVID-19.
I will avoid pregnancy during the study.
I can give my consent to participate.
You may not be able to join if
I am pregnant or breastfeeding.
I need extra oxygen to breathe.
I have had a fever or shortness of breath in the last 5 days.
I have a severe lung condition.
I have allergies to remdesivir.
I am participating in another trial.
I have an active liver disease.
I have a serious health issue that requires hospitalization.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. At least 18 years-old
2. 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-st…
Inclusion Criteria:
1. At least 18 years-old
2. 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.
3. Have a positive SARS-CoV-2 nasopharyngeal PCR or RAT within 5 days prior to transplant surgery.
4. Have previously received at least three SARS-CoV-2 vaccine doses, with a minimum time elapsed of 3 months since the last dose received.
5. 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.
6. 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 fe-male; 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.
7. Having understood the information provided and capable of giving consent to participate in this trial by signing the Informed Consent document.
Exclusion Criteria:
1. Pregnant or breastfeeding women, at time of enrollment
2. Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis.
3. 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.
4. Patients having fever (\>38ºC) in the last 48 hours or shortness of breath in the previous 5 days.
5. Previous history of hypersensitivity, documented allergy or contraindications to receive remdesivir.
6. ABO incompatible kidney transplant
7. Desensitization therapy indicated as induction therapy for high immunological risk transplant with Donor Specific HLA Antibodies (DSA)
8. Participants who receive different types of induction immunosuppression other than the standard induction protocols with lymphocyte- depleting agents (thymoglobulin or basiliximab).
9. 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.
10. Suspected or confirmed concurrent active respiratory infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
11. 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.
12. Prior participation in this trial.
13. 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.
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