COVID - 19Phase 2COVIDKIDNEYNCT07197164
Safety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients
A Phase 2 study testing Remdesivir (RDV) in people with COVID - 19 and Renal Transplant, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID - 19, Renal Transplant, SARS CoV 2 Infection
- What is being tested?
- Remdesivir (RDV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 28 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
- 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.
- Having understood the information provided and capable of giving consent to participate in this trial by signing the Informed Consent document.
Who cannot join
- Pregnant or breastfeeding women, at time of enrollment
- Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis.
- 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
Show all 13Show fewer
- Desensitization therapy indicated as induction therapy for high immunological risk transplant with Donor Specific HLA Antibodies (DSA)
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cristina Herrero Sánchez contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Alba Romero Caballero, MD, MSc, +34 93 465 78 97, assaig@scienhub.org
About this study
Official title: Safety and Efficacy of 10-day Course of Remdesivir to Prevent Severe COVID-19 in Asymptomatic or Paucisymptomatic SARS-COV-2-positive Kidney Transplant Recipients: a Single-arm Proof-of-concept Interventional Trial
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
- COVID - 19, Renal Transplant, SARS CoV 2 Infection
- Being tested
- Remdesivir (RDV)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remdesivir (RDV)Drug
Also called Veklury
Participants will receive their first dose of remdesivir also within the 24 (+/-12) hours prior to going to the operating room. Remdesivir doses will be 200 mg on day 1, followed by 100 mg daily from days 2 to 10, for a total of 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Single Arm with remdesivir Receives: Drug: Remdesivir (RDV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of participants who develop severe COVID-19 following kidney transplantation
Primary estimates: Severe SARS-CoV-2 will be defined as: Hypoxemia (O2 sat <94%), one or more compatible respiratory symptoms (fever, dyspnea, increased respiratory frequency > 22, cough) AND new radiologic infiltrates compatible with COVID-19 in a chest X Ray, chest CT or ultrasound.
Measured: to 28 days and 90 days post-transplant
Secondary outcomes (7)
Number of deaths (all causes mortality) at days 28 and 90 post-transplant
the cumulative mortality at days 28 and 90 after transplant in asymptomatic or paucisymptomatic SARS-CoV-2-positive kidney transplant recipients receiving a 10-day course of remdesivir
Measured: at days 28 and 90 after transplant
Time (days) to resolution and to recovery of all targeted symptoms through Day 28 and Day 90
Duration of targeted COVID-19 symptoms (COVID-19 Questionnaire).
Measured: At day 28 and day 90
Proportion of participants requiring extension of the hospitalization beyond POD10 (all cause and related to COVID-19)
% participants with COVID complications at the hospitalization that requires invasive Mechanical ventilation, intensive care unit (ICU) stayed or extension of the hospitalization related to COVID-19
Measured: At day 28
Proportion of participants with symptomatic rebound through day 28.
% participant who, after an initial improvement or resolution of symptoms, experience a recurrence of symptoms within the 28-day follow-up period
Measured: At day 28
To describe the clearance kinetics of SARS-CoV-2 infection in the post-transplant period
Number and proportion of participants with negative nasopharyngeal SARS-CoV-2 PCR, and median CT values if positive, at POD 0 (time of diagnosis), POD5, POD10, POD14, POD21, and POD28 and Whole genome sequencing of SARS-CoV-2 to evaluate emergence of substitutions associated with resistance to remdesivir in participants who have a positive SARS-CoV-2 PCR and CT values below or equal to 25.
Measured: At day 0, 5, 10, 14, 21 and 28
Number of Participants with Treatment-Related Adverse Events
Incidence of SAEs and AEs leading to drug discontinuation and number and proportion of any treatment-emergent hepatic AE (Elevation of any grade in ALT or AST levels, prothrombin time or INR, or blood bilirubin), number and proportion of severe liver failures (defined as elevated LFTs and presence of coagulopathy or hepatic encephalopathy) and mumber of patients that develop hypersensitivity or infusion-related reactions
Measured: From enrollment to the end of study at 6 months
incidence of graft complications
Number and proportion of participants with stage 2 or 3 AKI and or that present a proven-biopsy showing acute humoral or cellular rejection and or dialysis needed
Measured: at day 7, day 28 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Sep 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 2, proof of concept open-label, single-center, single- arm clinical trial
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197164
- Sponsor's protocol ID
- COVIDKIDNEY
- Other IDs
- 2024-519272-96-00
- Acronym
- COVIDKIDNEY
- Status last verified
- Aug 2025
- First submitted
- 25 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of 10-day Course of Remdesivir to Prevent Severe COVID-19 in Asymptomatic or Paucisymptomatic SARS-COV-2-positive Kidney Transplant Recipients: a Single-arm Proof-of-concept Interventional Trial
- ClinicalTrials.gov ID
- NCT07197164
- Acronym / sponsor ID
- COVIDKIDNEY / COVIDKIDNEY
- Conditions
- COVID - 19, Renal Transplant, SARS CoV 2 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 2, proof of concept open-label, single-center, single- arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Remdesivir (RDV)Single Arm with remdesivir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding women, at time of enrollment
- Patients requiring supplementary oxygen at baseline or diagnosed with severe COPD or pulmonary fibrosis.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remdesivir (RDV)Also: VekluryParticipants will receive their first dose of remdesivir also within the 24 (+/-12) hours prior to going to the operating room. Remdesivir doses will be 200 mg on day 1, followed by 100 mg daily from days 2 to 10, for a total of 10 days. | Drug | Single Arm |
Primary outcome
Number and proportion of participants who develop severe COVID-19 following kidney transplantation
Time frame: to 28 days and 90 days post-transplant
Primary estimates: Severe SARS-CoV-2 will be defined as: Hypoxemia (O2 sat <94%), one or more compatible respiratory symptoms (fever, dyspnea, increased respiratory frequency > 22, cough) AND new radiologic infiltrates compatible with COVID-19 in a chest X Ray, chest CT or ultrasound.
7 secondary outcomes
Number of deaths (all causes mortality) at days 28 and 90 post-transplant
Time frame: at days 28 and 90 after transplant
Time (days) to resolution and to recovery of all targeted symptoms through Day 28 and Day 90
Time frame: At day 28 and day 90
Proportion of participants requiring extension of the hospitalization beyond POD10 (all cause and related to COVID-19)
Time frame: At day 28
Proportion of participants with symptomatic rebound through day 28.
Time frame: At day 28
To describe the clearance kinetics of SARS-CoV-2 infection in the post-transplant period
Time frame: At day 0, 5, 10, 14, 21 and 28
Number of Participants with Treatment-Related Adverse Events
Time frame: From enrollment to the end of study at 6 months
incidence of graft complications
Time frame: at day 7, day 28 and day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Related trials for COVID - 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Herrero Sánchez contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remdesivir (RDV) in people with COVID - 19 and Renal Transplant, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alba Romero Caballero, MD, MSc (+34 93 465 78 97, assaig@scienhub.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of participants who develop severe COVID-19 following kidney transplantation (time frame: to 28 days and 90 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.