COVID-19Phase 2NEREIDANCT05705167
Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care (NEREIDA)
A Phase 2 study testing Plitidepsin in people with COVID-19, run by PharmaMar at 44 sites in 11 countries.
Trial summary
The primary objective of this study is to evaluate efficacy of plitidepsin in pre-specified groups of immunocompromised patients with symptomatic COVID-19 requiring hospital care versus control in terms of mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Plitidepsin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 44 sitesin 11 countries
- Study dates
- 19 Apr 2023to 19 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed informed consent obtained prior to initiation of any study-specific procedures and study treatment.
- Participant aged ≥18 years.
- Participant diagnosed COVID-19, with the following characteristics:
- A regulatory-approved test, collected no more than 3 days prior to study randomisation, with either a Ct value ≤30 or a positive antigen test.
- Presence of any of the selected signs/symptom listed in the COVID-19 signs/symptoms checklist within the last 24 hours.
- Participant already admitted or requiring hospital care for symptomatic COVID-19, for which at least one antiviral has failed or cannot be used (i.e., contraindication, absence of labelled indication, guidelines or drug unavailability), after a minimum washout period of 24 hours for small molecules (e.g., remdesivir, molnupiravir, nirmaltrevir, ritonavir) and 5 days for antiviral monoclonal antibodies (e.g., tixagevimab + cilgavimab) or convalescent plasma.
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- Adequate bone marrow, liver, kidney, and metabolic function, defined by the following tests performed at local laboratory:
- Absolute neutrophil count ≥500/mm^3 (0.5 x 109/L).
- Platelet count ≥ 50 000/mm3 (50 x 109/L).
- Alanine transaminase (ALT) ≤3 x upper limit of normal (ULN) (≤5 x ULN if preexistent liver involvement by the underlying disease).
- Serum bilirubin ≤1.5 x ULN (or direct bilirubin <1.5 x ULN when total bilirubin is above ULN).
- Estimated glomerular filtration rate ≥30 mL/min (CKD-EPI Creatinine Equation [2021]).
- Females of child-bearing potential must have a negative serum or urine pregnancy test by local laboratory at screening and must be non-lactating.
- Females of child-bearing potential and fertile males with partners of child-bearing potential must use contraceptive methods as specified in the protocol.
- Group-specific inclusion criteria:
- Group 1 - Patients receiving, within the last 30 days, immune-suppressive therapy due to haematopoietic or organ transplantation.
- Group 2 - Participants receiving B-cell depleting therapies within the last 6 months (with the exception of CAR-T cell therapy for which time restriction is not applicable).
- Group 3 - Participants receiving, within the last 30 days, other immune-suppressive therapies.
- Group 4 - Other situations with immunodeficiency.
- Primary immune deficiencies.
- Human immunodeficiency virus (HIV) infection, with CD4^+ T lymphocyte < 200 cells/μL in the last month.
- Radiation therapy within the last 3 months- requires documentation of ALC < 500 cells/μL.
- Haematological neoplasia or myelodysplasia not currently receiving any therapy.
- Other situations with a documentation of ALC < 500 cells/μL.
Who cannot join
- Evidence of critical illness.
- Any of the following cardiac conditions or risk factors:
- Cardiac infarction or cardiac surgery episode within the last month.
- History of known congenital QT prolongation.
- Known structural cardiomyopathy with abnormal left ventricular ejection fraction (LVEF) (<50%).
- Current clinical evidence of heart failure or acute cardiac ischaemia (New York Heart Association (NYHA) class III-IV).
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- Hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) or contraindication to receive dexamethasone, antihistamine H1/H2, or anti-serotoninergic 5HT3 agents.
- Females who are pregnant or breast-feeding.
- Females and males with partners of child-bearing potential who are not using at least 1 protocol-specified method of contraception.
- Any situation currently requiring increasing needs of immune-suppressive agents.
- Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the participant or potentially impact on participant compliance or the safety/efficacy observations in the study.
- Participation in another clinical study involving an investigational drug within 30 days prior to screening.
Trial locations and contacts
44 sites in 11 countries.
44 sites in 11 countries
Spain18 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar - Parc de Salut Mar
Barcelona, 08003
Vall d'Hebron Institut de Recerca
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital San Pedro de Alcantara
Cáceres, 10003
Hospital Universitario de La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid, 28007
MD Anderson Cancer Center Madrid
Madrid, 28033
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario HM Sanchinarro
Madrid, 28050
Hospital Regional Universitario de Málaga - Hospital General
Málaga, 29010
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
Salamanca, 37007
Hospital Alvaro Cunqueiro - Clinico Universitario Vigo
Vigo, Pontevedra, 36213
Hospital Universitario Miguel Servet
Zaragoza, 50009
Greece6 sites
General Hospital of Athens Evangelismos
Athens, Attica, 10676
Laiko General Hospital of Athens
Athens, Attica, 11527
Alexandra General Hospital
Athens, Attica, 11528
University General Hospital Attikon
Athens, Attica, 124 62
General Hospital for Thoracic Diseases Sotiria
Athens, 11527
University Hospital of Ioannina
Ioannina, Epirus, 45500
France5 sites
Centre Hospitalier de la Côte Basque
Bayonne, Pyrénées-Atlantiques, 64109
Hôpitaux Civils de Colmar - Centre Hospitalier Louis Pasteur
Colmar, Grand Est, 68024
Cancer Research Centre of Lyon
Lyon, Auvergne-Rhône-Alpes, 69373
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Centre Hospitalier Régional Universitaire de Tours
Tours, Indre-et-Loire, 37044
Portugal4 sites
Hospital da Senhora da Oliveira - Guimarães
Guimarães, Braga District, 4835-044
Centro Hospitalar Universitário Lisboa Norte, E.P.E - Hospital De Santa Maria
Lisbon, Lisbon District, 1649-035
Hospital Pedro Hispano
Senhora da Hora, 4464-513
Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, 4434-502
Georgia3 sites
The First University Clinic of the Tbilisi State Medical University
Tbilisi, 0141
Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, 0144
Academician Vakhtang Bochorishvili Clinic
Tbilisi, 4600
Italy2 sites
Ente Ospedaliero Ospedali Galliera
Genova, 16128
IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Roma, Rome, 00149
United Kingdom2 sites
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, England, NE1 4LP
Belgium1 site
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, 3000
Israel1 site
Sheba Medical Center Hospital - Tel Hashomer
Ramat Gan, Tel Aviv, 52621
Poland1 site
Wojewódzki Specjalistyczny Szpital im. Dr. Władysława Biegańskiego
Lodz, Lódzkie, 91-347
About this study
Official title: A Multicentre, Open Label, Randomised, Controlled, Basket, Pragmatic, Phase II, Clinical and Translational Study to Determine the Efficacy and Safety of Plitidepsin Versus Control in Immunocompromised Adult Patients With Symptomatic COVID-19 Requiring Hospital Care
The primary objective of this study is to evaluate efficacy of plitidepsin in pre-specified groups of immunocompromised patients with symptomatic COVID-19 requiring hospital care versus control in terms of mortality.
- Conditions
- COVID-19
- Being tested
- Plitidepsin
- Keywords
- COVID-19, Plitidepsin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlitidepsinDrug
IV infusion over 60-minutes
| Study group | Role | What they receive |
|---|---|---|
| Plitidepsin 2.5 mg | Experimental | Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute intravenous (IV) infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) will be administered to participants of the following groups:
* Group 1 - Participants receiving immune-suppression due to haematopoietic or organ transplantation.
* Group 2 - Participants receiving B-cell depleting therapies.
* Group 3 - Participants receiving other immune-suppressive therapies.
* Group 4 - Other situations with immune deficiencies. Receives: Drug: Plitidepsin |
| Control | No intervention | Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) will be administered to participants of the following groups: * Group 1 - Participants receiving immune-suppression due to haematopoietic or organ transplantation. * Group 2 - Participants receiving B-cell depleting therapies. * Group 3 - Participants receiving other immune-suppressive therapies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-month All-cause Mortality Rate
In the event of the participant initiating another non-protocol therapy, 1-month all-cause mortality rate was evaluated regardless of initiation of new non-protocol therapy.
Measured: Day 1 to Day 30 (±2)
Secondary outcomes (7)
Time to Confirmed Negativisation in SARS-CoV-2 Antigen Test or Real Time Polymerase Chain Reaction (RT-PCR) Cycle Threshold (Ct) > 30
Time to confirmed negativisation in SARS-CoV antigen test or RT-PCR Ct>30 was calculated as time from randomisation to the corresponding event using Kaplan-Meier (KM) estimates. Participants with no available data for any time to event efficacy endpoint were censored at time 0, end of study (Day 60 ±3), or date of early study termination. Also, participants who had not achieved the time to event endpoint were censored at the last valid assessment.
Measured: Day 1 to Day 60 (±3)
Time to Sustained End of COVID-related Hospital Care
Time to sustained end of COVID-related hospital care from the time of randomisation was calculated as time from randomisation to the corresponding event using KM estimates. Participants with no available data for any time to event efficacy endpoint were censored at time 0, end of study (Day 60 ±3), or date of early study termination. Also, participants who had not achieved the time to event endpoint were censored at the last valid assessment.
Measured: Day 1 to Day 60 (±3)
Time to Sustained Improvement and Resolution of Selected COVID-19 Signs/Symptoms
Time to sustained improvement and resolution of all targeted COVID-19 signs/symptoms was calculated as time from randomisation to the corresponding event using KM estimates. Corresponding events were defined as the event occurring on the first of 4 consecutive days when all symptoms scored as National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0; category of moderate-severe intensity, or requiring medical intervention, or limiting instrumental activity of daily living are scored as mild or absent AND all symptoms scored mild or 0 (absent) at study entry are scored as 0. Participants with no available data for any time to event efficacy endpoint were censored at time 0, end of study (Day 60 ±3), or date of early study termination. Also, participants who had not achieved the time to event endpoint were censored at the last valid assessment.
Measured: Day 1 to Day 60 (±3)
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Distribution of participants according to their clinical status by the 11-category WHO CPS:
- Uninfected; no viral ribonucleic acid (RNA) detected
- Asymptomatic; viral RNA detected
- Symptomatic; independent
- Symptomatic; assistance needed
- Hospitalised; no oxygen therapy
- Hospitalised; oxygen by mask or nasal prongs
- Hospitalised; oxygen by non-invasive ventilation (NIV) or high flow
- Intubation and mechanical ventilation
- Mechanical ventilation or vasopressors
- Mechanical ventilation and vasopressors, dialysis, or extracorporeal membrane oxygenation (ECMO) OR
- Death.
Measured: Days 4 (±1), 8 (±1), 15 (±1), 30 (±2), and 60 (±3)
Number of Participants Requiring Oxygen Therapy
The maximum number of participants requiring oxygen therapy on any day during each visit window is reported.
Measured: Days 4 (±1), 8 (±1), 15 (±1), 30 (±2), and 60 (±3)
Time to Sustained Discontinuation of Oxygen Supplementation
Time to sustained discontinuation is calculated as time from randomisation to the corresponding event using KM estimates. Corresponding events were defined as discontinuation of oxygen supplementation for at least 7 days. Participants with no available data for any time to event efficacy endpoint were censored at time 0, end of study (Day 60 ±3), or date of early study termination. Also, participants who had not achieved the time to event endpoint were censored at the last valid assessment.
Measured: Day 1 to Day 60 (±3)
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Frequency of the following events (all-cause and treatment-related) are included:
- TEAEs
- TEAEs ≥ grade 3 according to the NCI CTCAE v5.0
- TEAEs of special interest
- Serious TEAEs
- Serious adverse reactions (SARs)
- AEs leading to treatment discontinuation
- Deaths (related to COVID-19/all)
Clinically relevant/significant changes from Baseline in laboratory parameters and vital signs were reported as AEs.
Measured: Day 1 to Day 60 (±3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start19 Apr 2023
- Primary completion19 Mar 2024
- Study completion19 Apr 2024
Why it stopped: Significant difficulties in the recruitment of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705167
- Sponsor's protocol ID
- AV-APL-B-002-22
- Other IDs
- 2022-002489-34
- Acronym
- NEREIDA
- Status last verified
- Sep 2024
- First submitted
- 21 Dec 2022
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Landete P, Caliman-Sturdza OA, Lopez-Martin JA, Preotescu L, Luca MC, Kotanidou A, Villares P, Iglesias SP, Guisado-Vasco P, Saiz-Lou EM, Del Carmen Farinas-Alvarez M, de Lucas EM, Perez-Alba E, Cisneros JM, Estrada V, Hidalgo-Tenorio C, Poulakou G, Torralba M, Fortun J, Garcia-Ocana P, Lemaignen A, Marcos-Martin M, Molina M, Paredes R, Perez-Rodriguez MT, Raev D, Ryan P, Meira F, Gomez J, Torres N, Lopez-Mendoza D, Jimeno J, Varona JF. A Phase III Randomized Controlled Trial of Plitidepsin, a Marine-Derived Compound, in Hospitalized Adults With Moderate COVID-19. Clin Infect Dis. 2024 Oct 15;79(4):910-919. doi: 10.1093/cid/ciae227.
PubMed 39182994
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open Label, Randomised, Controlled, Basket, Pragmatic, Phase II, Clinical and Translational Study to Determine the Efficacy and Safety of Plitidepsin Versus Control in Immunocompromised Adult Patients With Symptomatic COVID-19 Requiring Hospital Care
- ClinicalTrials.gov ID
- NCT05705167
- Acronym / sponsor ID
- NEREIDA / AV-APL-B-002-22
- Conditions
- COVID-19
- Keywords
- COVID-19, Plitidepsin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significant difficulties in the recruitment of participants.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate efficacy of plitidepsin in pre-specified groups of immunocompromised patients with symptomatic COVID-19 requiring hospital care versus control in terms of mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plitidepsin 2.5 mg | Experimental | Drug: PlitidepsinBest standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute intravenous (IV) infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) will be administered to participants of the following groups: * Group 1 - Participants receiving immune-suppression due to haematopoietic or organ transplantation. * Group 2 - Participants receiving B-cell depleting therapies. * Group 3 - Participants receiving other immune-suppressive therapies. * Group 4 - Other situations with immune deficiencies. |
| Control | No intervention | –Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) will be administered to participants of the following groups: * Group 1 - Participants receiving immune-suppression due to haematopoietic or organ transplantation. * Group 2 - Participants receiving B-cell depleting therapies. * Group 3 - Participants receiving other immune-suppressive therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Signed informed consent obtained prior to initiation of any study-specific procedures and study treatment.
- Participant aged ≥18 years.
- Participant diagnosed COVID-19, with the following characteristics:
- Participant already admitted or requiring hospital care for symptomatic COVID-19, for which at least one antiviral has failed or cannot be used (i.e., contraindication, absence of labelled indication, guidelines or drug unavailability), after a minimum washout period of 24 hours for small molecules (e.g., remdesivir, molnupiravir, nirmaltrevir, ritonavir) and 5 days for antiviral monoclonal antibodies (e.g., tixagevimab + cilgavimab) or convalescent plasma.
- Adequate bone marrow, liver, kidney, and metabolic function, defined by the following tests performed at local laboratory:
Key exclusion criteria (12 listed)
- Evidence of critical illness.
- Any of the following cardiac conditions or risk factors:
- Hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) or contraindication to receive dexamethasone, antihistamine H1/H2, or anti-serotoninergic 5HT3 agents.
- Females who are pregnant or breast-feeding.
- Females and males with partners of child-bearing potential who are not using at least 1 protocol-specified method of contraception.
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 |
|---|---|---|
| PlitidepsinIV infusion over 60-minutes | Drug | Plitidepsin 2.5 mg |
Primary outcome
One-month All-cause Mortality Rate
Time frame: Day 1 to Day 30 (±2)
In the event of the participant initiating another non-protocol therapy, 1-month all-cause mortality rate was evaluated regardless of initiation of new non-protocol therapy.
7 secondary outcomes
Time to Confirmed Negativisation in SARS-CoV-2 Antigen Test or Real Time Polymerase Chain Reaction (RT-PCR) Cycle Threshold (Ct) > 30
Time frame: Day 1 to Day 60 (±3)
Time to Sustained End of COVID-related Hospital Care
Time frame: Day 1 to Day 60 (±3)
Time to Sustained Improvement and Resolution of Selected COVID-19 Signs/Symptoms
Time frame: Day 1 to Day 60 (±3)
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Time frame: Days 4 (±1), 8 (±1), 15 (±1), 30 (±2), and 60 (±3)
Number of Participants Requiring Oxygen Therapy
Time frame: Days 4 (±1), 8 (±1), 15 (±1), 30 (±2), and 60 (±3)
Time to Sustained Discontinuation of Oxygen Supplementation
Time frame: Day 1 to Day 60 (±3)
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 to Day 60 (±3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39182994Landete P, Caliman-Sturdza OA, Lopez-Martin JA, Preotescu L, Luca MC, Kotanidou A, Villares P, Iglesias SP, Guisado-Vasco P, Saiz-Lou EM, Del Carmen Farinas-Alvarez M, de Lucas EM, Perez-Alba E, Cisneros JM, Estrada V, Hidalgo-Tenorio C, Poulakou G, Torralba M, Fortun J, Garcia-Ocana P, Lemaignen A, Marcos-Martin M, Molina M, Paredes R, Perez-Rodriguez MT, Raev D, Ryan P, Meira F, Gomez J, Torres N, Lopez-Mendoza D, Jimeno J, Varona JF. A Phase III Randomized Controlled Trial of Plitidepsin, a Marine-Derived Compound, in Hospitalized Adults With Moderate COVID-19. Clin Infect Dis. 2024 Oct 15;79(4):910-919. doi: 10.1093/cid/ciae227.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plitidepsin in people with COVID-19, run by PharmaMar at 44 sites in 11 countries.
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 24 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Spain, Greece, France, Portugal, Georgia and 6 more countries. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-month All-cause Mortality Rate (time frame: Day 1 to Day 30 (±2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05705167, which also lists 1 linked publication.
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 2 Dec 2024.