Severe Acute Respiratory Syndrome Coronavirus 2FIBRO-COVIDNCT04987528
Pulmonary Fibrosis During Severe COVID-19 Pneumonia
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 and Acute Respiratory Distress Syndrome, run by Hôpital Européen Marseille at 1 site in France.
Trial summary
The COVID-19 pandemic is caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), an emerging coronavirus, which has already infected 192 million people with a case fatality rate close to 2%. About 5% of patients infected with SARS CoV-2 have a critical form with organ failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2, Acute Respiratory Distress Syndrome, Pulmonary Fibrosis
- What is being tested?
- Aminoterminal type III peptide of procollagen and Lung computed tomography
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will focused on patients with severe SARS Cov-2 pneumonia requiring ICU admission.
Who may be able to join
- Acute hypoxemic respiratory failure
- Positive SARS CoV-2 PCR on nasopharyngeal swab or distal airway sampling
- ICU admission during the hospital stay
Who cannot join
- Chronic respiratory failure (Oxygen or NIPPV at home)
- Patients with "Do Not Resuscitate" order at ICU admission
- Admission from an other ICU with a stay > 2 days
- Transfer to an another ICU during the ICU stay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence, Risk Factors and Prognosis of Pulmonary Fibrosis During Severe COVID-19 Pneumonia
The COVID-19 pandemic is caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), an emerging coronavirus, which has already infected 192 million people with a case fatality rate close to 2%. About 5% of patients infected with SARS CoV-2 have a critical form with organ failure. Among critical patients admitted to intensive care, about 70% of them will require ventilatory assistance by invasive mechanical ventilation (MV) with a mortality rate of 35% and a median MV duration of 12 days. The most severe lung damage resulting from SARS CoV-2 infection is the acute respiratory distress syndrome (ARDS). The virus infects alveolar epithelial cells and capillary endothelial cells leading to an activation of endothelium, hypercoagulability and thrombosis of pulmonary capillaries. This results in abnormal ventilation / perfusion ratios and profound hypoxemia. To date, the therapeutic management of severe SARS CoV-2 pneumonia lay on the early use of corticosteroids and Interleukin-6 (IL-6) receptor antagonist, which both reduce the need of MV and mortality. The risk factors of death in Intensive Care Unit (ICU) are: advanced age, severe obesity, coronary heart disease, active cancer, severe hypoxemia, and hepatic and renal failure on admission. Among MV patients, the death rate is doubled in those with both reduced thoracopulmonary compliance and elevated D-dimer levels. Patients with severe alveolar damage are at risk of progressing towards irreversible pulmonary fibrosis, the incidence of which still remain unknown. The diagnosis of pulmonary fibrosis is based on histology but there are some non-invasive alternative methods (serum or bronchoalveolar biomarkers, chest CT scan). We aim to assess the incidence of pulmonary fibrosis in patients with severe SARS CoV-2 related pneumonia. We will investigate the prognostic impact of fibrosis on mortality and the number of days alive free from MV at Day 90. Finally, we aim to identify risk factors of fibrosis.
Read the detailed description
Medical charts of patients admitted at the Intensive Care Unit (ICU) of the European Hospital of Marseille between March 2020 and June 2021 will be collected retrospectively using electronic database. Data collected will focus on demography, clinical variables, biological analyses, lung biopsies, and chest CT scans performed during the hospital stay.
Our routine protocol for COVID-19 management follows the "Coronavirus Disease 2019 (COVID-19) Treatment Guidelines" including the early use of corticosteroids (Dexamethasone) and IL-6 receptor antagonist (Tocilizumab). Additionally, we routinely perform, on a weekly basis, measurements of SARS CoV-2 viral load by PCR, SARS CoV-2 antibodies production, and biomarkers of fibrosis including hyaluronic acid (HA) and amino-terminal type I (PINP) and type III (PIIINP) peptides of procollagen.
The present study aim to determine the proportion of patients encountering non-invasive criteria of pulmonary fibrosis as defined by either typical CT scan patterns (reticulation and/or bronchiectasia), or increased serum concentration of PIIINP above 16 µg/L, or increased bronchoalveolar lavage (BAL) concentration of PIIINP above 9 µg/L.
A definitive diagnosis of lung fibrosis will be established according to lung pathology findings in patients for whom a lung biopsy have been performed during the hospital stay.
Patients with a diagnosis of pulmonary fibrosis will be compared with those without fibrosis, both in the population of mechanically ventilated patients and in those remained spontaneously breathing.
The primary end-point will be the number of days alive and free from the ventilator (ventilator-free days) at Day 90. The others outcomes of interest will be the duration of mechanical ventilation, the duration of ICU stay, the ICU mortality, the in-hospital mortality, the Day 28 mortality, and the Day 90 mortality.
The present study also aims to determine the risk factors of pulmonary fibrosis occurence, focusing on mechanical ventilatory settings, daily dose of corticosteroids, and the occurence of nosocomial pneumonia with special attention to lung reactivation of herpesviridae.
Finally, the relation between antibodies production and viral clearance (defined as the time to the first negative SARS CoV-2 PCR) or ICU survival will be investigated.
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2, Acute Respiratory Distress Syndrome, Pulmonary Fibrosis
- Being tested
- Aminoterminal type III peptide of procollagen, Lung computed tomography
- Keywords
- Mechanical Ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminoterminal type III peptide of procollagenDiagnostic test
Also called PIIINP
Serial Measurement of PIIINP in serum and/or BAL
Lung computed tomographyDiagnostic test
Also called Chest CT scan
Screening for the presence of reticulation or bronchiectasia within lung parenchyma
| Study group | Role | What they receive |
|---|---|---|
| Patients with pulmonary fibrosis | All ICU patients for which one of the non-invasive criteria of pulmonary fibrosis is reached :
* Typical CT scan patterns (reticulation and/or bronchiectasia)
* Serum PIIINP above 16 µg/L
* BAL PIIINP above 9 µg/L Receives: Diagnostic Test: Aminoterminal type III peptide of procollagen; Diagnostic Test: Lung computed tomography | |
| Patients without pulmonary fibrosis | All ICU patients for which none of the non-invasive criteria of pulmonary fibrosis are reached. Receives: Diagnostic Test: Aminoterminal type III peptide of procollagen; Diagnostic Test: Lung computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days
Number of days alive and free from mechanical ventilation
Measured: Day 90
Secondary outcomes (11)
Day 90 mortality
Mortality at Day 90
Measured: Day 90
Day 28 mortality
Mortality at Day 28
Measured: Day 28
ICU Mortality
Death from any cause during the ICU stay
Measured: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
In-hospital Mortality
Death from any cause during the Hospital stay
Measured: From date of hospital admission until the date of hospital liberation, assessed up to 12 months
Length of MV
Duration of mechanical ventilation during the ICU stay
Measured: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
Length of ICU stay
Duration of ICU stay
Measured: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
Length of hospital stay
Duration of hospital stay
Measured: From date of hospital admission until the date of hospital liberation, assessed up to 12 months
Time to viral clearance
Time from first symptom to the first negative SARS CoV-2 PCR
Measured: From date of first symptom until the date of ICU liberation, assessed up to 6 months
Corticosteroid dose
Daily corticosteroid dose (methylprednisolone equivalent)
Measured: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
Lung herpesviridae reactivation
Presence on BAL of at least one Herpesviridae (Cytomegalovirus, Epstein-Barr Virus, Herpes simplex virus, Human herpes virus-6)
Measured: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
Blood herpesviridae reactivation
Presence on serum of at least one Herpesviridae (Cytomegalovirus, Epstein-Barr Virus, Herpes simplex virus, Human herpes virus-6)
Measured: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start11 Mar 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (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 Severe Acute Respiratory Syndrome Coronavirus 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987528
- Sponsor's protocol ID
- 2021_06_02_JAS
- Acronym
- FIBRO-COVID
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2021
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 Aug 25;324(8):782-793. doi: 10.1001/jama.2020.12839.
PubMed 32648899COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021 Jan;47(1):60-73. doi: 10.1007/s00134-020-06294-x. Epub 2020 Oct 29.
PubMed 33211135Grasselli G, Tonetti T, Protti A, Langer T, Girardis M, Bellani G, Laffey J, Carrafiello G, Carsana L, Rizzuto C, Zanella A, Scaravilli V, Pizzilli G, Grieco DL, Di Meglio L, de Pascale G, Lanza E, Monteduro F, Zompatori M, Filippini C, Locatelli F, Cecconi M, Fumagalli R, Nava S, Vincent JL, Antonelli M, Slutsky AS, Pesenti A, Ranieri VM; collaborators. Pathophysiology of COVID-19-associated acute respiratory distress syndrome: a multicentre prospective observational study. Lancet Respir Med. 2020 Dec;8(12):1201-1208. doi: 10.1016/S2213-2600(20)30370-2. Epub 2020 Aug 27.
PubMed 32861276Forel JM, Guervilly C, Hraiech S, Voillet F, Thomas G, Somma C, Secq V, Farnarier C, Payan MJ, Donati SY, Perrin G, Trousse D, Dizier S, Chiche L, Baumstarck K, Roch A, Papazian L. Type III procollagen is a reliable marker of ARDS-associated lung fibroproliferation. Intensive Care Med. 2015 Jan;41(1):1-11. doi: 10.1007/s00134-014-3524-0. Epub 2014 Oct 30.
PubMed 25354475Burnham EL, Hyzy RC, Paine R 3rd, Kelly AM, Quint LE, Lynch D, Curran-Everett D, Moss M, Standiford TJ. Detection of fibroproliferation by chest high-resolution CT scan in resolving ARDS. Chest. 2014 Nov;146(5):1196-1204. doi: 10.1378/chest.13-2708.
PubMed 24722949
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors and Prognosis of Pulmonary Fibrosis During Severe COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04987528
- Acronym / sponsor ID
- FIBRO-COVID / 2021_06_02_JAS
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2, Acute Respiratory Distress Syndrome, Pulmonary Fibrosis
- Keywords
- Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Aug 2021 (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 COVID-19 pandemic is caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), an emerging coronavirus, which has already infected 192 million people with a case fatality rate close to 2%. About 5% of patients infected with SARS CoV-2 have a critical form with organ failure. Among critical patients admitted to intensive care, about 70% of them will require ventilatory assistance by invasive mechanical ventilation (MV) with a mortality rate of 35% and a median MV duration of 12 days. The most severe lung damage resulting from SARS CoV-2 infection is the acute respiratory distress syndrome (ARDS). The virus infects alveolar epithelial cells and capillary endothelial cells leading to an activation of endothelium, hypercoagulability and thrombosis of pulmonary capillaries. This results in abnormal ventilation / perfusion ratios and profound hypoxemia. To date, the therapeutic management of severe SARS CoV-2 pneumonia lay on the early use of corticosteroids and Interleukin-6 (IL-6) receptor antagonist, which both reduce the need of MV and mortality. The risk factors of death in Intensive Care Unit (ICU) are: advanced age, severe obesity, coronary heart disease, active cancer, severe hypoxemia, and hepatic and renal failure on admission. Among MV patients, the death rate is doubled in those with both reduced thoracopulmonary compliance and elevated D-dimer levels. Patients with severe alveolar damage are at risk of progressing towards irreversible pulmonary fibrosis, the incidence of which still remain unknown. The diagnosis of pulmonary fibrosis is based on histology but there are some non-invasive alternative methods (serum or bronchoalveolar biomarkers, chest CT scan). We aim to assess the incidence of pulmonary fibrosis in patients with severe SARS CoV-2 related pneumonia. We will investigate the prognostic impact of fibrosis on mortality and the number of days alive free from MV at Day 90. Finally, we aim to identify risk factors of fibrosis.
Detailed description
Medical charts of patients admitted at the Intensive Care Unit (ICU) of the European Hospital of Marseille between March 2020 and June 2021 will be collected retrospectively using electronic database. Data collected will focus on demography, clinical variables, biological analyses, lung biopsies, and chest CT scans performed during the hospital stay.
Our routine protocol for COVID-19 management follows the "Coronavirus Disease 2019 (COVID-19) Treatment Guidelines" including the early use of corticosteroids (Dexamethasone) and IL-6 receptor antagonist (Tocilizumab). Additionally, we routinely perform, on a weekly basis, measurements of SARS CoV-2 viral load by PCR, SARS CoV-2 antibodies production, and biomarkers of fibrosis including hyaluronic acid (HA) and amino-terminal type I (PINP) and type III (PIIINP) peptides of procollagen.
The present study aim to determine the proportion of patients encountering non-invasive criteria of pulmonary fibrosis as defined by either typical CT scan patterns (reticulation and/or bronchiectasia), or increased serum concentration of PIIINP above 16 µg/L, or increased bronchoalveolar lavage (BAL) concentration of PIIINP above 9 µg/L.
A definitive diagnosis of lung fibrosis will be established according to lung pathology findings in patients for whom a lung biopsy have been performed during the hospital stay.
Patients with a diagnosis of pulmonary fibrosis will be compared with those without fibrosis, both in the population of mechanically ventilated patients and in those remained spontaneously breathing.
The primary end-point will be the number of days alive and free from the ventilator (ventilator-free days) at Day 90. The others outcomes of interest will be the duration of mechanical ventilation, the duration of ICU stay, the ICU mortality, the in-hospital mortality, the Day 28 mortality, and the Day 90 mortality.
The present study also aims to determine the risk factors of pulmonary fibrosis occurence, focusing on mechanical ventilatory settings, daily dose of corticosteroids, and the occurence of nosocomial pneumonia with special attention to lung reactivation of herpesviridae.
Finally, the relation between antibodies production and viral clearance (defined as the time to the first negative SARS CoV-2 PCR) or ICU survival will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary fibrosis | – | Diagnostic Test: Aminoterminal type III peptide of procollagen, Diagnostic Test: Lung computed tomographyAll ICU patients for which one of the non-invasive criteria of pulmonary fibrosis is reached : * Typical CT scan patterns (reticulation and/or bronchiectasia) * Serum PIIINP above 16 µg/L * BAL PIIINP above 9 µg/L |
| Patients without pulmonary fibrosis | – | Diagnostic Test: Aminoterminal type III peptide of procollagen, Diagnostic Test: Lung computed tomographyAll ICU patients for which none of the non-invasive criteria of pulmonary fibrosis are reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will focused on patients with severe SARS Cov-2 pneumonia requiring ICU admission.
Key inclusion criteria (3 listed)
- Acute hypoxemic respiratory failure
- Positive SARS CoV-2 PCR on nasopharyngeal swab or distal airway sampling
- ICU admission during the hospital stay
Key exclusion criteria (4 listed)
- Chronic respiratory failure (Oxygen or NIPPV at home)
- Patients with "Do Not Resuscitate" order at ICU admission
- Admission from an other ICU with a stay > 2 days
- Transfer to an another ICU during the ICU stay
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 |
|---|---|---|
| Aminoterminal type III peptide of procollagenAlso: PIIINPSerial Measurement of PIIINP in serum and/or BAL | Diagnostic test | Patients with pulmonary fibrosis, Patients without pulmonary fibrosis |
| Lung computed tomographyAlso: Chest CT scanScreening for the presence of reticulation or bronchiectasia within lung parenchyma | Diagnostic test | Patients with pulmonary fibrosis, Patients without pulmonary fibrosis |
Primary outcome
Ventilator-free days
Time frame: Day 90
Number of days alive and free from mechanical ventilation
11 secondary outcomes
Day 90 mortality
Time frame: Day 90
Day 28 mortality
Time frame: Day 28
ICU Mortality
Time frame: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
In-hospital Mortality
Time frame: From date of hospital admission until the date of hospital liberation, assessed up to 12 months
Length of MV
Time frame: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
Length of ICU stay
Time frame: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
Length of hospital stay
Time frame: From date of hospital admission until the date of hospital liberation, assessed up to 12 months
Time to viral clearance
Time frame: From date of first symptom until the date of ICU liberation, assessed up to 6 months
Corticosteroid dose
Time frame: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
Lung herpesviridae reactivation
Time frame: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
Blood herpesviridae reactivation
Time frame: From date of ICU admission until the date of ICU liberation, assessed up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 32648899Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 Aug 25;324(8):782-793. doi: 10.1001/jama.2020.12839.
- Background: PubMed 33211135COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021 Jan;47(1):60-73. doi: 10.1007/s00134-020-06294-x. Epub 2020 Oct 29.
- Background: PubMed 32861276Grasselli G, Tonetti T, Protti A, Langer T, Girardis M, Bellani G, Laffey J, Carrafiello G, Carsana L, Rizzuto C, Zanella A, Scaravilli V, Pizzilli G, Grieco DL, Di Meglio L, de Pascale G, Lanza E, Monteduro F, Zompatori M, Filippini C, Locatelli F, Cecconi M, Fumagalli R, Nava S, Vincent JL, Antonelli M, Slutsky AS, Pesenti A, Ranieri VM; collaborators. Pathophysiology of COVID-19-associated acute respiratory distress syndrome: a multicentre prospective observational study. Lancet Respir Med. 2020 Dec;8(12):1201-1208. doi: 10.1016/S2213-2600(20)30370-2. Epub 2020 Aug 27.
- Background: PubMed 25354475Forel JM, Guervilly C, Hraiech S, Voillet F, Thomas G, Somma C, Secq V, Farnarier C, Payan MJ, Donati SY, Perrin G, Trousse D, Dizier S, Chiche L, Baumstarck K, Roch A, Papazian L. Type III procollagen is a reliable marker of ARDS-associated lung fibroproliferation. Intensive Care Med. 2015 Jan;41(1):1-11. doi: 10.1007/s00134-014-3524-0. Epub 2014 Oct 30.
- Background: PubMed 24722949Burnham EL, Hyzy RC, Paine R 3rd, Kelly AM, Quint LE, Lynch D, Curran-Everett D, Moss M, Standiford TJ. Detection of fibroproliferation by chest high-resolution CT scan in resolving ARDS. Chest. 2014 Nov;146(5):1196-1204. doi: 10.1378/chest.13-2708.
- World Health Organization Coronavirus (COVID-19) DashboardLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 and Acute Respiratory Distress Syndrome, run by Hôpital Européen Marseille at 1 site in France.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. 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 France. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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 days (time frame: Day 90). 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 NCT04987528, 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 26 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.