Coronavirus Disease 2019 (COVID-19) PneumoniaPhase 3NCT04351152
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19
A Phase 3 study testing Lenzilumab in people with Coronavirus Disease 2019 (COVID-19) Pneumonia, run by Humanigen, Inc. at 29 sites in 2 countries.
Trial summary
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in hospitalized subjects with severe or critical COVID-19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease 2019 (COVID-19) Pneumonia
- What is being tested?
- Lenzilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 5 May 2020to Mar 2021
- Phase
- Phase 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
Who may be able to join
- Adults 18 years of age or older who are capable of providing informed consent or have a proxy capable of giving consent for them
- Virologic confirmation of SARS-CoV-2 infection via any FDA authorized diagnostic test for SARS-CoV-2
- Pneumonia diagnosed by Chest X-ray or Computed Tomography revealing infiltrates consistent with pneumonia
- SpO2 ≤ 94% on room air and/or require low-flow supplemental oxygen and/or require high-flow oxygen support or NIPPV
- Hospitalized, not requiring invasive mechanical ventilation during this hospitalization
- Have not participated in other clinical trial for COVID-19 using an immunomodulatory monoclonal antibody or kinase inhibitor (use of remdesivir, corticosteroids, convalescent plasma, hydroxychloroquine or chloroquine is permitted)
- Females of childbearing potential must have a negative serum or urine pregnancy test
Who cannot join
- Requiring invasive mechanical ventilation or extracorporeal membrane oxygenation prior to randomization
- Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline
- Known active tuberculosis (TB), history of incompletely treated TB or suspected or known extrapulmonary TB
- Currently receiving treatment for hepatitis A, hepatitis B, hepatitis C or HIV infection
- History of pulmonary alveolar proteinosis (PAP)
- Women of childbearing potential who are pregnant or breastfeeding
Show all 11Show fewer
- Known hypersensitivity to lenzilumab or any of its components
- Use of any FDA authorized anti-IL-6 (e.g., tocilizumab, sarilumab, sitlukimab), anti-IL-1 (e.g., anakinra, canakinumab), kinase inhibitor (e.g., baracitinib, ibrutinib, acalabrutinib), or neutralizing monoclonal antibody (e.g. bamlanivimab or casirivimab/imdevimab) therapy to treat COVID-19 within 8 weeks prior to randomization
- Use of GM-CSF agents (e.g., sargramostim) within prior 2 months of randomization
- Expected survival < 48h in the opinion of the investigator
- Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States18 sites
Emory University
Atlanta, Georgia, 30322
St. David's Healthcare
Austin, Texas, 78705
St. David's North Austin Medical Center
Austin, Texas, 78758
Atrium Health
Charlotte, North Carolina, 28203
Texas Health
Dallas, Texas, 75231
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
University of California, Irvine
Irvine, California, 92697
Mayo Clinic
Jacksonville, Florida, 32216
Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
University of Southern California (USC) Medical Center
Los Angeles, California, 90033
USC - Los Angeles County Medical Center
Los Angeles, California, 90033
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
AdventHealth Orlando
Orlando, Florida, 32803
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
Mercy Medical Center
Rockville Centre, New York, 11570
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Brazil11 sites
Hospital Vera Cruz
Belo Horizonte, Minas Gerais, 30140-060
Hospital Dia do Pulmão
Blumenau, São Paulo, 89030-101
Sociedade Literaria e Caritativa Santo Agostinho
Criciúma, Santa Catarina, 88811-500
CPCLIN - Centro de Pesquisas Clínicas de Natal
Natal, Rio Grande do Norte, 59025-050
Hospital São Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital Guilherme Alvaro
Santos, São Paulo, 11045-904
CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA-EPP
São Bernardo do Campo, São Paulo, 09715-090
Escola Paulista de Medicina (UNIFESP)
São Paulo, 04037-002
Hospital Heliópolis
São Paulo, 04231-030
Hospital São Luiz do Jabaquara/IDOR
São Paulo, 04501-000
Clinica de Alergia Martti Antila S/S LTDA
Sorocaba, São Paulo, 18040-425
About this study
Official title: A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in hospitalized subjects with severe or critical COVID-19 pneumonia.
Read the detailed description
In COVID-19, high levels of granulocyte macrophage-colony stimulating factor (GM-CSF) and inflammatory myeloid cells correlate with disease severity, cytokine storm, and respiratory failure. The mortality rate for hospitalized COVID-19 patients remains unacceptably high, particularly in patients who progress to invasive mechanical ventilation (IMV). This randomized, double-blind, multicenter, placebo-controlled pivotal phase 3 trial will evaluate the impact of lenzilumab (anti-human GM-CSF monoclonal antibody) on ventilator-free survival in hospitalized, hypoxic patients with COVID-19. The study is also designed to evaluate other key endpoints, including ventilator-free days, duration of ICU stay, incidence of IMV, ECMO and/or death, time to death, all-cause mortality and time to recovery.
Approximately 516 patients will be randomized to receive lenzilumab + SOC vs. placebo + SOC in a 1:1 ratio.
- Being tested
- Lenzilumab, Standard of Care
- Keywords
- Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), GM-CSF monoclonal antibody, Cytokine Release Syndrome (CRS), Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Lenzilumab, Cytokine Storm
- Medical subject headings
- COVID-19, Pneumonia, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenzilumabBiological
Also called Humaneered® anti-human GM-CSF monoclonal Antibody
Administered as an intravenous (IV) infusion
Standard of CareDrug
Standard of care therapy can include remdesivir and/or dexamethasone per institutional treatment guidelines or written policies
| Study group | Role | What they receive |
|---|---|---|
| Lenzilumab Arm | Experimental | Participants will receive IV infusion of lenzilumab upon randomization at a pre-specified dosing interval and continued administration of standard of care Receives: Biological: Lenzilumab; Drug: Standard of Care |
| Placebo Arm | Placebo comparator | Participants will receive IV infusion of preservative-free 0.9% sodium chloride solution upon randomization matched to lenzilumab at same pre-specified dosing interval and continued administration of standard of care Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free Survival
Measured: Up to Day 28
Secondary outcomes (18)
Ventilator-free Days
Measured: Up to Day 28
Duration of Intensive Care Unit (ICU) Stay
Measured: Up to Day 28
Incidence of Invasive Mechanical Ventilation, ECMO and/or Death
Measured: Up to Day 28
Time to Death
Measured: Up to Day 28
All-cause Mortality
Measured: Day 28
Time to Recovery
Time to recovery is defined as the first day on which a subject satisfies one of the following 3 categories from the 8-point ordinal scale (Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities).
Measured: Up to Day 28
Incidence of severe acute respiratory distress syndrome (ARDS)
Measured: Up to Day 28
Duration of Hospitalization
Measured: Up to Day 28
Time to Improvement in 1 or 2 Categories using 8-point Ordinal Scale
Measured: Up to Day 28
Number of Subjects Alive and Off Oxygen
Measured: Up to Day 60
Percentage of Participants Experiencing Adverse Events
Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Up to Day 60
Percentage of Participants Experiencing Serious Adverse Events
Using the NCI CTCAE version 5.0
Measured: Up to Day 60
Proportion of Subjects Discharged from Hospital
Measured: Up to Day 60
Time to improvement in oxygenation for > 48 hours
Measured: Up to Day 28
Incidence of Non-invasive Ventilation (or Use of High-flow Oxygen Device)
Measured: Up to Day 28
Time to Clinical Improvement, Defined as NEWS2 < 2 Maintained for 24 Hours
NEWS2 consists of: Physiological Parameters: respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), use of air or oxygen, systolic blood pressure (mmHg), pulse (per minute), consciousness and temperature (°C)
Measured: Up to Day 28
Change from Baseline to Day 28 in Clinical status Based on the 8-point Ordinal Scale
Measured: Up to Day 28
Duration of Time on Low-flow or High-flow Supplemental Oxygen
Measured: Up 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 posted17 Apr 2020
- Study start5 May 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease 2019 (COVID-19) PneumoniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanigen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cameron Durrant, MD, Study director, Humanigen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351152
- Sponsor's protocol ID
- HGEN003-06
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Temesgen Z, Kelley CF, Cerasoli F, Kilcoyne A, Chappell D, Durrant C, Ahmed O, Chappell G, Catterson V, Polk C, Badley A, Marconi VC; LIVE-AIR Study Group. C reactive protein utilisation, a biomarker for early COVID-19 treatment, improves lenzilumab efficacy: results from the randomised phase 3 'LIVE-AIR' trial. Thorax. 2023 Jun;78(6):606-616. doi: 10.1136/thoraxjnl-2022-218744. Epub 2022 Jul 6.
PubMed 35793833Temesgen Z, Burger CD, Baker J, Polk C, Libertin CR, Kelley CF, Marconi VC, Orenstein R, Catterson VM, Aronstein WS, Durrant C, Chappell D, Ahmed O, Chappell G, Badley AD; LIVE-AIR Study Group. Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial. Lancet Respir Med. 2022 Mar;10(3):237-246. doi: 10.1016/S2213-2600(21)00494-X. Epub 2021 Dec 1.
PubMed 34863332Temesgen Z, Burger CD, Baker J, Polk C, Libertin C, Kelley C, Marconi VC, Orenstein R, Durrant C, Chappell D, Ahmed O, Chappell G, Badley AD. LENZILUMAB EFFICACY AND SAFETY IN NEWLY HOSPITALIZED COVID-19 SUBJECTS: RESULTS FROM THE LIVE-AIR PHASE 3 RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL. medRxiv [Preprint]. 2021 May 5:2021.05.01.21256470. doi: 10.1101/2021.05.01.21256470.
PubMed 33972949Aroldi A, Chiarle R, Gambacorti-Passerini C. Clinical Benefit of Lenzilumab in Cases of Coronavirus Disease 2019. Mayo Clin Proc. 2021 Mar;96(3):817. doi: 10.1016/j.mayocp.2020.12.030. Epub 2021 Jan 11. No abstract available.
PubMed 33673929Temesgen Z, Assi M, Shweta FNU, Vergidis P, Rizza SA, Bauer PR, Pickering BW, Razonable RR, Libertin CR, Burger CD, Orenstein R, Vargas HE, Palraj R, Dababneh AS, Chappell G, Chappell D, Ahmed O, Sakemura R, Durrant C, Kenderian SS, Badley AD. GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Cohort Study. Mayo Clin Proc. 2020 Nov;95(11):2382-2394. doi: 10.1016/j.mayocp.2020.08.038. Epub 2020 Sep 3.
PubMed 33153629
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04351152
- Acronym / sponsor ID
- HGEN003-06
- Keywords
- Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), GM-CSF monoclonal antibody, Cytokine Release Syndrome (CRS), Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Lenzilumab, Cytokine Storm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Humanigen, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 May 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 17 Apr 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.
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival in hospitalized subjects with severe or critical COVID-19 pneumonia.
Detailed description
In COVID-19, high levels of granulocyte macrophage-colony stimulating factor (GM-CSF) and inflammatory myeloid cells correlate with disease severity, cytokine storm, and respiratory failure. The mortality rate for hospitalized COVID-19 patients remains unacceptably high, particularly in patients who progress to invasive mechanical ventilation (IMV). This randomized, double-blind, multicenter, placebo-controlled pivotal phase 3 trial will evaluate the impact of lenzilumab (anti-human GM-CSF monoclonal antibody) on ventilator-free survival in hospitalized, hypoxic patients with COVID-19. The study is also designed to evaluate other key endpoints, including ventilator-free days, duration of ICU stay, incidence of IMV, ECMO and/or death, time to death, all-cause mortality and time to recovery.
Approximately 516 patients will be randomized to receive lenzilumab + SOC vs. placebo + SOC in a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenzilumab Arm | Experimental | Biological: Lenzilumab, Drug: Standard of CareParticipants will receive IV infusion of lenzilumab upon randomization at a pre-specified dosing interval and continued administration of standard of care |
| Placebo Arm | Placebo comparator | Drug: Standard of CareParticipants will receive IV infusion of preservative-free 0.9% sodium chloride solution upon randomization matched to lenzilumab at same pre-specified dosing interval and continued administration of standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18 years of age or older who are capable of providing informed consent or have a proxy capable of giving consent for them
- Virologic confirmation of SARS-CoV-2 infection via any FDA authorized diagnostic test for SARS-CoV-2
- Pneumonia diagnosed by Chest X-ray or Computed Tomography revealing infiltrates consistent with pneumonia
- SpO2 ≤ 94% on room air and/or require low-flow supplemental oxygen and/or require high-flow oxygen support or NIPPV
- Hospitalized, not requiring invasive mechanical ventilation during this hospitalization
Key exclusion criteria (11 listed)
- Requiring invasive mechanical ventilation or extracorporeal membrane oxygenation prior to randomization
- Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline
- Known active tuberculosis (TB), history of incompletely treated TB or suspected or known extrapulmonary TB
- Currently receiving treatment for hepatitis A, hepatitis B, hepatitis C or HIV infection
- History of pulmonary alveolar proteinosis (PAP)
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 |
|---|---|---|
| LenzilumabAlso: Humaneered® anti-human GM-CSF monoclonal AntibodyAdministered as an intravenous (IV) infusion | Biological | Lenzilumab Arm |
| Standard of CareStandard of care therapy can include remdesivir and/or dexamethasone per institutional treatment guidelines or written policies | Drug | Lenzilumab Arm, Placebo Arm |
Primary outcome
Ventilator-free Survival
Time frame: Up to Day 28
18 secondary outcomes
Ventilator-free Days
Time frame: Up to Day 28
Duration of Intensive Care Unit (ICU) Stay
Time frame: Up to Day 28
Incidence of Invasive Mechanical Ventilation, ECMO and/or Death
Time frame: Up to Day 28
Time to Death
Time frame: Up to Day 28
All-cause Mortality
Time frame: Day 28
Time to Recovery
Time frame: Up to Day 28
Incidence of severe acute respiratory distress syndrome (ARDS)
Time frame: Up to Day 28
Duration of Hospitalization
Time frame: Up to Day 28
Time to Improvement in 1 or 2 Categories using 8-point Ordinal Scale
Time frame: Up to Day 28
Number of Subjects Alive and Off Oxygen
Time frame: Up to Day 60
Percentage of Participants Experiencing Adverse Events
Time frame: Up to Day 60
Percentage of Participants Experiencing Serious Adverse Events
Time frame: Up to Day 60
Proportion of Subjects Discharged from Hospital
Time frame: Up to Day 60
Time to improvement in oxygenation for > 48 hours
Time frame: Up to Day 28
Incidence of Non-invasive Ventilation (or Use of High-flow Oxygen Device)
Time frame: Up to Day 28
Time to Clinical Improvement, Defined as NEWS2 < 2 Maintained for 24 Hours
Time frame: Up to Day 28
Change from Baseline to Day 28 in Clinical status Based on the 8-point Ordinal Scale
Time frame: Up to Day 28
Duration of Time on Low-flow or High-flow Supplemental Oxygen
Time frame: Up to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 35793833Temesgen Z, Kelley CF, Cerasoli F, Kilcoyne A, Chappell D, Durrant C, Ahmed O, Chappell G, Catterson V, Polk C, Badley A, Marconi VC; LIVE-AIR Study Group. C reactive protein utilisation, a biomarker for early COVID-19 treatment, improves lenzilumab efficacy: results from the randomised phase 3 'LIVE-AIR' trial. Thorax. 2023 Jun;78(6):606-616. doi: 10.1136/thoraxjnl-2022-218744. Epub 2022 Jul 6.
- Derived from this study: PubMed 34863332Temesgen Z, Burger CD, Baker J, Polk C, Libertin CR, Kelley CF, Marconi VC, Orenstein R, Catterson VM, Aronstein WS, Durrant C, Chappell D, Ahmed O, Chappell G, Badley AD; LIVE-AIR Study Group. Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial. Lancet Respir Med. 2022 Mar;10(3):237-246. doi: 10.1016/S2213-2600(21)00494-X. Epub 2021 Dec 1.
- Derived from this study: PubMed 33972949Temesgen Z, Burger CD, Baker J, Polk C, Libertin C, Kelley C, Marconi VC, Orenstein R, Durrant C, Chappell D, Ahmed O, Chappell G, Badley AD. LENZILUMAB EFFICACY AND SAFETY IN NEWLY HOSPITALIZED COVID-19 SUBJECTS: RESULTS FROM THE LIVE-AIR PHASE 3 RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL. medRxiv [Preprint]. 2021 May 5:2021.05.01.21256470. doi: 10.1101/2021.05.01.21256470.
- Derived from this study: PubMed 33673929Aroldi A, Chiarle R, Gambacorti-Passerini C. Clinical Benefit of Lenzilumab in Cases of Coronavirus Disease 2019. Mayo Clin Proc. 2021 Mar;96(3):817. doi: 10.1016/j.mayocp.2020.12.030. Epub 2021 Jan 11. No abstract available.
- Derived from this study: PubMed 33153629Temesgen Z, Assi M, Shweta FNU, Vergidis P, Rizza SA, Bauer PR, Pickering BW, Razonable RR, Libertin CR, Burger CD, Orenstein R, Vargas HE, Palraj R, Dababneh AS, Chappell G, Chappell D, Ahmed O, Sakemura R, Durrant C, Kenderian SS, Badley AD. GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Cohort Study. Mayo Clin Proc. 2020 Nov;95(11):2382-2394. doi: 10.1016/j.mayocp.2020.08.038. Epub 2020 Sep 3.
- Individual participant dataSharing planned: Yes
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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.
Cameron Durrant, MD study director
Humanigen, Inc.
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lenzilumab in people with Coronavirus Disease 2019 (COVID-19) Pneumonia, run by Humanigen, Inc. at 29 sites in 2 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Brazil. 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 phase mean?
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?
Results are not available in the source record.
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?
Ventilator-free Survival (time frame: Up to Day 28). 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 NCT04351152, which also lists 5 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 3 Mar 2021.