COVID-19Phase 2/3NECTARNCT05593770
International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response
A Phase 2/3 study testing Fostamatinib in people with COVID-19 and SARS-CoV2 Infection, run by NEAT ID Foundation at 21 sites in 5 countries.
Trial summary
The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV2 Infection, Coronavirus Infection
- What is being tested?
- Fostamatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 27 Oct 2022to 14 Dec 2023
- Phase
- Phase 2/3
- 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
- Hospitalized for COVID-19
- ≥18 years of age
- SARS-CoV-2 infection, documented by:
- nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR
- documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non- NAT tests is maintained in Appendix E. Appendix E. Non-NAT Tests Deemed with Equivalent Specificity to NAT by the Protocol Team).
- Hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy
Show all 12Show fewer
- Symptoms or signs of acute COVID-19, defined as one or more of the following:
- cough
- reported or documented body temperature of 100.4 degrees Fahrenheit or greater
- shortness of breath
- chest pain
- infiltrates on chest imaging (x-ray, CT scan, lung ultrasound)
Who cannot join
- Onset of COVID-19 symptom fulfilling inclusion criterion #5 >14 days prior to randomization
- Hospitalized with hypoxemia (as defined in inclusion #4) for >72 hours prior to randomization (the 72-hour window for randomization begins when the patient first meets the hypoxemia inclusion criteria after hospital admission)
- Pregnancy
- Breastfeeding
- Prisoners
- End-stage renal disease (ESRD) on dialysis
Show all 18Show fewer
- Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.
- The treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient
- Known allergy/hypersensitivity to IMP or its excipients
- Fostamatinib Arm-Specific Exclusion Criteria:
- The following exclusion criteria differ from the master protocol criteria:
- 1. Randomized in another trial evaluating fostamatinib in the prior 30 days
- Study arm exclusion criteria measured within 24 hours prior to randomization:
- AST or ALT ≥ 5 × upper limit of normal (ULN) or ALT or AST ≥ 3 × ULN and total bilirubin ≥ 2 × ULN
- SBP > 160 mmHg or DBP > 100 mmHg at the time of screening and randomization
- ANC < 1000/mL
- Patient is anticipated to require a strong CYP3A inhibitor (Atazanavir, Certinib, Clarithromycin, Cobicistat and cobicistat-containing coformulations, Idelalisib,Indinavir, Itraconazole, Ketoconazole, Levoketoconazole, Lonafarnib, Lopinavir, Mifeprostone, Mibefradil, Nefazodone, Nelfinavir, Ombitasvir-paritaprevir-ritonavir plus dasabuvir, Posaconazole, Ribociclib Ritonavir, Saquinavir, Telithromycin, Troleandomycin, Tucatinib, Voriconazole) from randomization to 21 days post-randomization. For a full list of CYP3A4 substrates, please reference this regularly updated list: https://drug-interactions.medicine.iu.edu/MainTable.aspx.
- Patient unable to participate or declines participation in the fostamatinib arm.
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
Spain9 sites
Hospital General Universitario de Elche
Alicante
Hospital Clinic Barcelona
Barcelona, Villarroel
Hospital del Mar
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Clinico San Carlos
Madrid
Hospital Universitario Fundacion Alcorcon
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Universidad de Valladolid - Hospital Universitario Río Hortega
Valladolid
Hospital Clinico Universitario Lozano Blesa
Zaragoza
Italy4 sites
Ente Ospedaliero Ospedali Galliera
Genova
San Paolo Hospital - ASST Santi Paolo e Carlo
Milan
San Raffaele Turro Hospital
Milan
University of Milan
Milan
Brazil3 sites
Hospital de Clínicas de Porto Alegre
Porto Alegre
Hospital Federal dos Servidores do Estado
Rio de Janeiro
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro
South Africa3 sites
Worthwhile Clinical Trials (WWCT Lakeview Hospital)
Benoni
Clinical HIV Research Unit - Helen Joseph Hospital (WITS CHRU)
Johannesburg
Global Clinical Trials (Pty) Ltd
Pretoria
About this study
Official title: International Sites: CONNECTS Master Protocol for Clinical Trials Targeting Macro-, Micro-immuno-thrombosis, Vascular Hyperinflammation, and Hypercoagulability and Renin-angiotensin-aldosterone System (RAAS) in Hospitalized Patients With COVID-19 (ACTIV-4 Host Tissue)
The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.
Read the detailed description
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), has resulted in a global pandemic. The clinical spectrum of COVID-19 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness, and severe viral pneumonia with respiratory failure and death. Between 13 and 40% of patients become hospitalized, up to 30% of those hospitalized require admission for intensive care, and there is a 13% inpatient mortality rate. The reasons for hospitalization include respiratory support, as well as support for failure of other organs, including the heart and kidneys. The risk of thrombotic complications is increased, even when compared to other viral respiratory illnesses, such as influenza. While 82% of hospitalized patients with COVID-19 are ultimately discharged alive, median length of stay is 10-13 days.
Early work in treating COVID-19 has focused on preventing worsening of the initial clinical presentation to prevent hospitalization and disease progression to organ failure and death. Studies conducted under this Master Host Tissue Protocol are expected to extend our knowledge of how to manage patients who are hospitalized for COVID-19 illness. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. This Master Protocol is a randomized, placebo-controlled trial of agents targeting the host response in COVID-19 in hospitalized patients with hypoxemia. The Master Host Tissue Protocol is designed to be flexible in the number of study arms, the use of a single placebo group, and the stopping and adding of new therapies. Our primary outcome is oxygen free days through day 28. This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days.
- Conditions
- COVID-19, SARS-CoV2 Infection, Coronavirus Infection
- Being tested
- Fostamatinib, Placebo
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FostamatinibDrug
Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
PlaceboDrug
Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
| Study group | Role | What they receive |
|---|---|---|
| Fostamatinib | Experimental | An investigational oral spleen tyrosine kinase inhibitor. Receives: Drug: Fostamatinib |
| Placebo | Placebo comparator | Orange film-coated, plain, bioconvex tablets for fostamatinib.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Free Days Through Day 28
This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Measured: Day 1 to Day 28
Secondary outcomes (13)
In-hospital Mortality
Number of patients who die during hospitalization
Measured: Day 1 to hospital discharge or Day 90 whichever comes first
Alive and Oxygen Free at Day 14
Number of patients oxygen free at day 14. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Measured: Day 1 to Day 14
Alive and Oxygen Free at Day 28
Number of patients oxygen free at day 28. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO)
Measured: Day 1 to Day 28
Alive and Free of New Invasive Mechanical Ventilation at Day 28
Number of patients alive free of new invasive mechanical ventilation at day 28
Measured: Day 1 to Day 28
28-day Mortality
Number of patients who have died at Day 28
Measured: Day 28
60-day Mortality
Number of patients who have died at Day 60
Measured: Day 60
90-day Mortality
Number of participants mortality at Day 90
Measured: Day 90
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Number of participants who fell within the ordinal scale per the below criteria. A higher score indicates a worse outcome.
- Ambulatory - Not hospitalized and no limitation of activities
- Ambulatory - Not hospitalized with limitation of activities or home oxygen use
- Hospitalized Mild Disease - Hospitalized, no oxygen therapy
- Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
- Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
- Hospitalized Severe Disease -Invasive mechanical ventilation
- Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
- Dead
Measured: Day 14
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
The number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome
- Ambulatory - Not hospitalized and no limitation of activities
- Ambulatory - Not hospitalized with limitation of activities or home oxygen use
- Hospitalized Mild Disease - Hospitalized, no oxygen therapy
- Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
- Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
- Hospitalized Severe Disease -Invasive mechanical ventilation
- Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
- Dead
Measured: Day 28
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome
- Ambulatory - Not hospitalized and no limitation of activities
- Ambulatory - Not hospitalized with limitation of activities or home oxygen use
- Hospitalized Mild Disease - Hospitalized, no oxygen therapy
- Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs
- Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula
- Hospitalized Severe Disease -Invasive mechanical ventilation
- Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO
- Dead
Measured: Day 60
Hospital-free Days Through Day 28
Days alive and not hospitalized during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Measured: Day 1 to Day 28
Ventilator-free Days Through Day 28
Days alive and not receiving mechanical ventilation during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Measured: Day 1 to Day 28
Respiratory Failure-free Days Through Day 28
Days alive and not in respiratory failure during the first 28 days following randomization. A respiratory failure-free day is defined as a day alive without the use of HFNC, NIV, IMV, or (ECMO). Patients who die on or before day 28 are assigned a value -1.
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start27 Oct 2022
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Why it stopped: Following a meeting of the DSMB on 20th September 2023, the recommendation was made to the sponsor on 26th September 2023 that the Fostamatinib arm of the trial ceases enrolment and study medication is discontinued immediately.
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated in a two-step process: 1) The participant will first be randomized in an m:1 ratio to receive an active study drug or placebo, where m represents the number of study drug arms for which the participant is eligible. 2) The participant will then be randomly assigned with equal probability to one of the study drug arms. Participants will receive the corresponding study drug or matching placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- NEAT ID Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anton Pozniak, Prof, Principal investigator, NEAT ID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593770
- Sponsor's protocol ID
- ACTIV-4
- Acronym
- NECTAR
- Status last verified
- Apr 2025
- First submitted
- 21 Oct 2022
- Last updated
- 2 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Sites: CONNECTS Master Protocol for Clinical Trials Targeting Macro-, Micro-immuno-thrombosis, Vascular Hyperinflammation, and Hypercoagulability and Renin-angiotensin-aldosterone System (RAAS) in Hospitalized Patients With COVID-19 (ACTIV-4 Host Tissue)
- ClinicalTrials.gov ID
- NCT05593770
- Acronym / sponsor ID
- NECTAR / ACTIV-4
- Conditions
- COVID-19, SARS-CoV2 Infection, Coronavirus Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following a meeting of the DSMB on 20th September 2023, the recommendation was made to the sponsor on 26th September 2023 that the Fostamatinib arm of the trial ceases enrolment and study medication is discontinued immediately.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NEAT ID FoundationUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.
Detailed description
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), has resulted in a global pandemic. The clinical spectrum of COVID-19 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness, and severe viral pneumonia with respiratory failure and death. Between 13 and 40% of patients become hospitalized, up to 30% of those hospitalized require admission for intensive care, and there is a 13% inpatient mortality rate. The reasons for hospitalization include respiratory support, as well as support for failure of other organs, including the heart and kidneys. The risk of thrombotic complications is increased, even when compared to other viral respiratory illnesses, such as influenza. While 82% of hospitalized patients with COVID-19 are ultimately discharged alive, median length of stay is 10-13 days.
Early work in treating COVID-19 has focused on preventing worsening of the initial clinical presentation to prevent hospitalization and disease progression to organ failure and death. Studies conducted under this Master Host Tissue Protocol are expected to extend our knowledge of how to manage patients who are hospitalized for COVID-19 illness. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. This Master Protocol is a randomized, placebo-controlled trial of agents targeting the host response in COVID-19 in hospitalized patients with hypoxemia. The Master Host Tissue Protocol is designed to be flexible in the number of study arms, the use of a single placebo group, and the stopping and adding of new therapies. Our primary outcome is oxygen free days through day 28. This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated in a two-step process: 1) The participant will first be randomized in an m:1 ratio to receive an active study drug or placebo, where m represents the number of study drug arms for which the participant is eligible. 2) The participant will then be randomly assigned with equal probability to one of the study drug arms. Participants will receive the corresponding study drug or matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Fostamatinib | Experimental | Drug: FostamatinibAn investigational oral spleen tyrosine kinase inhibitor. |
| Placebo | Placebo comparator | Drug: PlaceboOrange film-coated, plain, bioconvex tablets for fostamatinib. For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Hospitalized for COVID-19
- ≥18 years of age
- SARS-CoV-2 infection, documented by:
- Hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy
- Symptoms or signs of acute COVID-19, defined as one or more of the following:
Key exclusion criteria (18 listed)
- Onset of COVID-19 symptom fulfilling inclusion criterion #5 >14 days prior to randomization
- Hospitalized with hypoxemia (as defined in inclusion #4) for >72 hours prior to randomization (the 72-hour window for randomization begins when the patient first meets the hypoxemia inclusion criteria after hospital admission)
- Pregnancy
- Breastfeeding
- Prisoners
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 |
|---|---|---|
| FostamatinibFostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses. | Drug | Fostamatinib |
| PlaceboOrange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses. | Drug | Placebo |
Primary outcome
Oxygen Free Days Through Day 28
Time frame: Day 1 to Day 28
This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
13 secondary outcomes
In-hospital Mortality
Time frame: Day 1 to hospital discharge or Day 90 whichever comes first
Alive and Oxygen Free at Day 14
Time frame: Day 1 to Day 14
Alive and Oxygen Free at Day 28
Time frame: Day 1 to Day 28
Alive and Free of New Invasive Mechanical Ventilation at Day 28
Time frame: Day 1 to Day 28
28-day Mortality
Time frame: Day 28
60-day Mortality
Time frame: Day 60
90-day Mortality
Time frame: Day 90
Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14
Time frame: Day 14
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Time frame: Day 28
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Time frame: Day 60
Hospital-free Days Through Day 28
Time frame: Day 1 to Day 28
Ventilator-free Days Through Day 28
Time frame: Day 1 to Day 28
Respiratory Failure-free Days Through Day 28
Time frame: Day 1 to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Anton Pozniak, Prof principal investigator
NEAT ID
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fostamatinib in people with COVID-19 and SARS-CoV2 Infection, run by NEAT ID Foundation at 21 sites in 5 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 12 inclusion and 18 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 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain, Italy, Brazil, South Africa, Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 Nov 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?
Oxygen Free Days Through Day 28 (time frame: Day 1 to Day 28). 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 2 May 2025.