COVID-19Phase 2/3NCT04393246
mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms
A Phase 2/3 study testing EDP1815, Dapagliflozin and Ambrisentan in people with COVID-19, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
TACTIC-E is a randomised, parallel arm, open-label platform trial for investigating potential treatments for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the first 24 hours of infection, it ultimately produces a massive immune system response in the subgroup of people who develop… 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?
- EDP1815, Dapagliflozin and Ambrisentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jul 2020to 8 Jun 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
General Inclusion Criteria:
- Be aged 18 and over
- Have clinical picture strongly suggestive of COVID-19-related disease (with/without positive COVID-19 test) AND
- Risk count (as defined below) >3 OR
- Risk count ≥3 if it includes "Radiographic severity score >3"
- Be hospitalized or eligible for hospitalization on clinical grounds
- Be considered an appropriate subject for intervention with immunomodulatory or other disease modifying agents in the opinion of the investigator
- Is able to swallow capsules/tablets
General Exclusion Criteria:
- Inability to supply direct informed consent from patient or from Next of Kin or Independent Healthcare Provider on behalf of patient
- Invasive mechanical ventilation at time of screening
- Contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients
- Currently on any of the study investigational medicinal products
- Concurrent participation in an interventional clinical trial (observational studies allowed)
- Patient moribund at presentation or screening
- Pregnancy at screening
- Unwilling to stop breastfeeding during treatment period
- Known severe hepatic impairment (with or without cirrhosis)
- Requiring dialysis Cockcroft Gault estimated creatinine clearance < 30 ml /min/1.73m2 at screening
- Inability to swallow at screening visit
- Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern.
EDP1815-Specific Exclusion Criteria:
- Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin or tacrolimus, unless these are given as part of COVID standard of care treatment.
- Patient has known primary or secondary B cell disorder
Dapagliflozin- and Ambrisentan-Specific Exclusion Criteria:
- Type 1 diabetes
- Known idiopathic pulmonary fibrosis
- Previous hospital admission with ketoacidosis
- Patients concurrently on other SGLT2 inhibitors
- History of symptomatic heart failure within 3 months of admission
- Sustained blood pressure below 100/70 mmHg at admission
- Metabolic acidosis defined as pH< 7.25 AND ketones > 3.0 mmol/L
- Alanine transaminase and/or aspartate transaminase (ALT and/or AST) > 3 times the upper limit of normal (only one needs to be measured)
Risk Count
Patients will be given a Risk Count equal to the cumulative points received for the following criteria (no = 0 points, yes = 1 point):
Male gender, Age > 40 years, Non-white ethnicity, Diabetes, Hypertension, Neutrophils > 8.0x10^9/L, CRP > 40mg/L, Radiographic severity score >3
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms (TACTIC-E)
TACTIC-E is a randomised, parallel arm, open-label platform trial for investigating potential treatments for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the first 24 hours of infection, it ultimately produces a massive immune system response in the subgroup of people who develop severe complications. Most tissue damage following infection with COVID-19 appears to be due to a later, exaggerated, host immune response (Gralinski and Baric 2015). This leads to lung and sometimes multi-organ damage.
Most people who develop these severe complications still have virus present in their respiratory tract at the time-point when the disease starts to evolve. Immune modulation in the presence of active infection has potential to cause more harm than benefit. Safety considerations when studying immune modulation strategies are paramount. This study will assess the efficacy of a novel immunomodulatory agent and a novel combination of approved agents which may protect the patient against end-organ damage and modulate the pulmonary vascular response. This study will compare the novel therapeutic agent EDP1815 and a novel combination of the approved agents dapagliflozin and ambrisentan against Standard of Care. A trial arm (UNI911) with the IMP Niclosamide was added to the protocol with one patient recruited into this arm. Following an AESI and after discussions between the funder and the Sponsor the arm was stopped.
Read the detailed description
TACTIC-E will assess the efficacy of the novel immunomodulatory agent EDP1815 and a combination of the approved cardiovascular drugs dapagliflozin and ambrisentan as potential treatments for COVID-19 disease against Standard of Care alone. These agents target the dysregulated immune response that drive the severe lung, and other organ, damage frequently seen during COVID-19 infection, with an aim to promote a positive vascular response to reduce end-organ damage.
Treatment with EDP1815 will be for up to 7 days, with the option of extension to 14 days at the discretion of the PI or their delegate, if the patient is felt to be clinically responding to treatment, is tolerating treatment, and is judged to be likely to benefit from a longer treatment course. Treatment with combination dapagliflozin and ambrisentan will be for up to 14 days. Patients will be randomised in a 1:1:1 ratio across treatments.
TACTIC-E will use a platform design with interim analysis to make efficient decisions about efficacy and futility (e.g. lack of efficacy and risk of harm) of the trial treatments. This enables the trial to stop recruiting to arms early where a clear efficacy decision can be made. It also allows for the addition of further arms.
- Conditions
- COVID-19
- Being tested
- EDP1815, Dapagliflozin, Ambrisentan, Standard of care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP1815Drug
EDP1815 is an orally administered pharmaceutical preparation of a single strain of Prevotella histicola isolated from the duodenum of a human donor. EDP1815 is currently in phase 2 clinical development and has European and US approval to initiate a multinational psoriasis study.
DapagliflozinDrug
Also called Forxiga
Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT-2) inhibitor. Dapagliflozin is licensed for use in the UK for treatment of Type II diabetes. Since this trial is evaluating Dapagliflozin in an unlicensed indication, it is being carried out under a Clinical Trial Authorisation (CTA)
AmbrisentanDrug
Also called Letairis, Volibris, Pulmonext
Ambrisentan is an endothelin receptor antagonist, and is selective for the type A endothelin receptor (ETA). Ambrisentan was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and indicated for the treatment of pulmonary arterial hypertension.
Standard of careOther
Regular standard of care for COVID-19 patients
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Standard of care Receives: Other: Standard of care |
| EDP1815 | Experimental | 1.6 x 10^11 cells dosage-in-capsule orally twice per day for up to 7 days (with the option to extend up to 14 days), on top of standard of care Receives: Drug: EDP1815 |
| Dapagliflozin and Ambrisentan | Experimental | Ambrisentan 5mg tablet orally once per day for up to a maximum of 14 days and Dapagliflozin 10mg tablet orally once per day for up to a maximum of 14 days, on top of standard of care Receives: Drug: Dapagliflozin; Drug: Ambrisentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to incidence of the composite endpoint of: Death, Mechanical ventilation, ECMO, Cardiovascular organ support, or Renal failure
Number of days taken for occurrence of one of the following events: 1. Death 2. Mechanical ventilation 3. Extracorporeal membrane oxygenation (ECMO) 4. Cardiovascular organ support (balloon pump or inotropes/vassopressors) 5. Renal failure (estimated creatinine clearance (by Cockcroft-Gault formula) <15 ml /min/1.73m^2), haemofiltration or dialysis
Measured: up to Day 14
Secondary outcomes (15)
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: IL-6
Change in patient blood levels of IL-6 compared to baseline, measured in pg/mL
Measured: 14 days
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: ferritin
Change in patient blood levels of ferritin compared to baseline, measured in ng/mL
Measured: 14 days
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: c-reactive protein (CRP)
Change in patient blood levels of CRP compared to baseline, measured in mg/L
Measured: 14 days
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: D-dimer
Change in patient blood levels of D-dimer compared to baseline, measured in ng/mL
Measured: 14 days
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: neutrophil/lymphocyte ratio
Change in patient blood levels of neutrophil/lymphocyte ratio compared to baseline
Measured: 14 days
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: lactate dehydrogenase (LDH)
Change in patient blood levels of lactate dehydrogenase (LDH) compared to baseline, measured in U/L
Measured: 14 days
Change in clinical status as assessed on 7-point ordinal scale compared to baseline
The clinical status of the patients is assessed using 7-point ordinal scale as follows: 1 = Death, 2 = Mechanical ventilation, 3 = Non-invasive or high flow oxygen, 4 = Low flow oxygen, 5 = Hospitalised - no oxygen, 6 = Discharged - normal activities not resumed, 7 = Discharged - normal activities resumed
Measured: 14 days
Time to each of the individual endpoints of the composite primary outcome measure
Number of days taken for occurrence of each of the following events: 1. Death 2. Mechanical ventilation 3. Extracorporeal membrane oxygenation (ECMO) 4. Cardiovascular organ support (balloon pump or inotropes/vassopressors) 5. Renal failure (estimated creatinine clearance (by Cockcroft-Gault formula) <15 ml /min/1.73m^2), haemofiltration or dialysis
Measured: 14 days
Proportion of patients with adverse events of special interest in each treatment arm
The proportion of patients in each treatment arm that experience adverse events of special interest, defined as: Diabetic ketoacidosis in patients on Ambrisentan \& Dapagliflozin, New peripheral oedema in patients on Ambrisentan \& Dapagliflozin arm
Measured: 14 days
Time to Sp02 >94% on room air
The time taken to achieve blood oxygen saturation levels above 94% in patients on room air, measured in hours/days (chronically hypoxic individuals will be excluded from this analysis)
Measured: 14 days
Time to first negative SARS-CoV2 PCR
The amount of time between a patient's first positive SARS-CoV2 PCR test and a patient's first negative SARS-CoV2 PCR test, measured in days
Measured: 14 days
Duration of oxygen therapy
The duration of oxygen therapy given to a patient, measured in days
Measured: 14 days
Duration of hospitalisation
The duration of hospitalisation of a patient, measured in days
Measured: 14 days
All-cause mortality at day 28
The number of deaths recorded at 28 days irrespective of the cause
Measured: 28 days
Time to clinical improvement
The time to clinical improvement for a patient, defined as: >2 point improvement from Day 1 on the 7-point ordinal scale, measured in days
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start3 Jul 2020
- Primary completion1 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TACTIC-E is a randomised, parallel arm, open-label platform trial
- Masking
- None (open label)
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Joseph Cheriyan, MBChB MA FRCP, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393246
- Sponsor's protocol ID
- TACTIC-E
- Status last verified
- Jul 2023
- First submitted
- 16 May 2020
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gralinski LE, Baric RS. Molecular pathology of emerging coronavirus infections. J Pathol. 2015 Jan;235(2):185-95. doi: 10.1002/path.4454.
PubMed 25270030Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343Lu IN, Kulkarni S, Fisk M, Kostapanos M, Banham-Hall E, Kadyan S, Bond S, Norton S, Cope A, Galloway J, Hall F, Jayne D, Wilkinson IB, Cheriyan J. muLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E): A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Jul 31;21(1):690. doi: 10.1186/s13063-020-04618-2.
PubMed 32736592
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms (TACTIC-E)
- ClinicalTrials.gov ID
- NCT04393246
- Acronym / sponsor ID
- TACTIC-E
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 19 May 2020 (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.
TACTIC-E is a randomised, parallel arm, open-label platform trial for investigating potential treatments for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the first 24 hours of infection, it ultimately produces a massive immune system response in the subgroup of people who develop severe complications. Most tissue damage following infection with COVID-19 appears to be due to a later, exaggerated, host immune response (Gralinski and Baric 2015). This leads to lung and sometimes multi-organ damage.
Most people who develop these severe complications still have virus present in their respiratory tract at the time-point when the disease starts to evolve. Immune modulation in the presence of active infection has potential to cause more harm than benefit. Safety considerations when studying immune modulation strategies are paramount. This study will assess the efficacy of a novel immunomodulatory agent and a novel combination of approved agents which may protect the patient against end-organ damage and modulate the pulmonary vascular response. This study will compare the novel therapeutic agent EDP1815 and a novel combination of the approved agents dapagliflozin and ambrisentan against Standard of Care. A trial arm (UNI911) with the IMP Niclosamide was added to the protocol with one patient recruited into this arm. Following an AESI and after discussions between the funder and the Sponsor the arm was stopped.
Detailed description
TACTIC-E will assess the efficacy of the novel immunomodulatory agent EDP1815 and a combination of the approved cardiovascular drugs dapagliflozin and ambrisentan as potential treatments for COVID-19 disease against Standard of Care alone. These agents target the dysregulated immune response that drive the severe lung, and other organ, damage frequently seen during COVID-19 infection, with an aim to promote a positive vascular response to reduce end-organ damage.
Treatment with EDP1815 will be for up to 7 days, with the option of extension to 14 days at the discretion of the PI or their delegate, if the patient is felt to be clinically responding to treatment, is tolerating treatment, and is judged to be likely to benefit from a longer treatment course. Treatment with combination dapagliflozin and ambrisentan will be for up to 14 days. Patients will be randomised in a 1:1:1 ratio across treatments.
TACTIC-E will use a platform design with interim analysis to make efficient decisions about efficacy and futility (e.g. lack of efficacy and risk of harm) of the trial treatments. This enables the trial to stop recruiting to arms early where a clear efficacy decision can be made. It also allows for the addition of further arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- TACTIC-E is a randomised, parallel arm, open-label platform trial
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of careStandard of care |
| EDP1815 | Experimental | Drug: EDP18151.6 x 10^11 cells dosage-in-capsule orally twice per day for up to 7 days (with the option to extend up to 14 days), on top of standard of care |
| Dapagliflozin and Ambrisentan | Experimental | Drug: Dapagliflozin, Drug: AmbrisentanAmbrisentan 5mg tablet orally once per day for up to a maximum of 14 days and Dapagliflozin 10mg tablet orally once per day for up to a maximum of 14 days, on top of standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| EDP1815EDP1815 is an orally administered pharmaceutical preparation of a single strain of Prevotella histicola isolated from the duodenum of a human donor. EDP1815 is currently in phase 2 clinical development and has European and US approval to initiate a multinational psoriasis study. | Drug | EDP1815 |
| DapagliflozinAlso: ForxigaDapagliflozin is a sodium-glucose co-transporter 2 (SGLT-2) inhibitor. Dapagliflozin is licensed for use in the UK for treatment of Type II diabetes. Since this trial is evaluating Dapagliflozin in an unlicensed indication, it is being carried out under a Clinical Trial Authorisation (CTA) | Drug | Dapagliflozin and Ambrisentan |
| AmbrisentanAlso: Letairis, Volibris, PulmonextAmbrisentan is an endothelin receptor antagonist, and is selective for the type A endothelin receptor (ETA). Ambrisentan was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and indicated for the treatment of pulmonary arterial hypertension. | Drug | Dapagliflozin and Ambrisentan |
| Standard of careRegular standard of care for COVID-19 patients | Other | Standard of care |
Primary outcome
Time to incidence of the composite endpoint of: Death, Mechanical ventilation, ECMO, Cardiovascular organ support, or Renal failure
Time frame: up to Day 14
Number of days taken for occurrence of one of the following events: 1. Death 2. Mechanical ventilation 3. Extracorporeal membrane oxygenation (ECMO) 4. Cardiovascular organ support (balloon pump or inotropes/vassopressors) 5. Renal failure (estimated creatinine clearance (by Cockcroft-Gault formula) <15 ml /min/1.73m^2), haemofiltration or dialysis
15 secondary outcomes
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: IL-6
Time frame: 14 days
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: ferritin
Time frame: 14 days
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: c-reactive protein (CRP)
Time frame: 14 days
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: D-dimer
Time frame: 14 days
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: neutrophil/lymphocyte ratio
Time frame: 14 days
Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: lactate dehydrogenase (LDH)
Time frame: 14 days
Change in clinical status as assessed on 7-point ordinal scale compared to baseline
Time frame: 14 days
Time to each of the individual endpoints of the composite primary outcome measure
Time frame: 14 days
Proportion of patients with adverse events of special interest in each treatment arm
Time frame: 14 days
Time to Sp02 >94% on room air
Time frame: 14 days
Time to first negative SARS-CoV2 PCR
Time frame: 14 days
Duration of oxygen therapy
Time frame: 14 days
Duration of hospitalisation
Time frame: 14 days
All-cause mortality at day 28
Time frame: 28 days
Time to clinical improvement
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 25270030Gralinski LE, Baric RS. Molecular pathology of emerging coronavirus infections. J Pathol. 2015 Jan;235(2):185-95. doi: 10.1002/path.4454.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- Derived from this study: PubMed 32736592Lu IN, Kulkarni S, Fisk M, Kostapanos M, Banham-Hall E, Kadyan S, Bond S, Norton S, Cope A, Galloway J, Hall F, Jayne D, Wilkinson IB, Cheriyan J. muLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E): A structured summary of a study protocol for a randomized controlled trial. Trials. 2020 Jul 31;21(1):690. doi: 10.1186/s13063-020-04618-2.
- 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.
Joseph Cheriyan, MBChB MA FRCP principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EDP1815, Dapagliflozin and Ambrisentan in people with COVID-19, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 28 Jul 2023. 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 United Kingdom. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to incidence of the composite endpoint of: Death, Mechanical ventilation, ECMO, Cardiovascular organ support, or Renal failure (time frame: up to Day 14). 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 NCT04393246, which also lists 3 linked publications.
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 28 Jul 2023.