COVIDPOCUSCONCT04338100
Point Of Care UltraSonography for Risk-stratification of COVID-19 Patients
An observational study of COVID and Coronavirus Infection, run by University Hospital, Angers at 11 sites in 2 countries.
Trial summary
COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Coronavirus Infection
- What is being tested?
- Follow-up at 14 days
- Type of treatment
- Surgery or procedure
- How many people
- 307 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 8 Apr 2020to 23 Jun 2020
- Phase
- Observational
- 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
Study population: Adults patients consulting emergency department with non-severe suspected or confirmed SARS-CoV-2 infection (COVID-19)
Who may be able to join
- Patient with COVID-19 confirmed by positive RT-PCR or considered as probable by the in-charge physician,
- ≥18 years old,
- Not requiring respiratory assistance and/or other intensive care
- Not subject to a limitation of active therapeutics
Who cannot join
- History of pneumonectomy
- Any reason making chest ultrasonography impossible
- Any reason making 14-day follow-up impossible
- Patient opposition to research participation.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
France10 sites
MORIN François
Angers, 49933
COUTURAUD Francis
Brest, 29200
BAUDIN Laure
Cholet, 49325
TAZAROURTE Karim
Lyon, 69002
LE CONTE Philippe
Nantes, 44093
MARJANOVIC Nicolas
Poitiers, 86000
SOULAT Louis
Rennes, 35033
JOLY Luc-Marie
Rouen, 76000
DELOMAS Thomas
Saint-Lô, 50000
FLAMENT Thomas
Tours, 37044
About this study
Official title: Point Of Care UltraSonography to Perform Risk-stratification of Patients With Suspected or Confirmed COVID-19 - POCUSCO Study
COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue.
While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation.
Read more
Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients.
Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date.
Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.
Read the detailed description
Patients consulting in the emergeny department of participating centres for suspected or confirmed COVID-19 are checked for inclusion and non-inclusion criteria and asked for study participation.
Including patients have point-of-care lung ultrasonography (POCUS) performed within 48 hours following ED admission. The severity of lung damage is assessed using the lung ultrasonography score on 36 points for ARDS (POCUS score).
Apart POCUS score assessment, patients are managed as usual.
If a chest CT scan is performed, its result is collected and, in particular, the quantification of the extent of pulmonary lesions in percentage from 0 to 100%, carried out according to the recommendations of the French Society of Radiology.
For hospitalized patients, if possible, a second chest ultrasonography is performed on Day 5 +/- 3. The extent of lung damage is assessed by the POCUS score.
A follow-up is carried out on day 14 (D14) and the patient's status according to the "Ordinal Scale for Clinical Improvement" for COVID-19 from WHO is recorded.
- Conditions
- COVID, Coronavirus Infection
- Being tested
- Follow-up at 14 days
- Keywords
- COVID-19, SARS-CoV-2, POCUS, Lung ultrasonography, Risk-stratification
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up at 14 daysProcedure or surgery
Point of care chest ultrasonography and 14-day follow-up to assess the evolution of the infection and care requirement (invasive ventilation or death)
| Study group | Role | What they receive |
|---|---|---|
| Chest Ultrasound | Only one arm, all included patients having chest ultrasonography. Receives: Procedure: Follow-up at 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of unfavourable outcome at D14
To assess, in patients with confirmed or probable SARS-CoV-2 infection, chest ultrasonography capacity, using the POCUS score for ARDS, to identify patients with unfavourable outcome at D14.
Unfavourable outcome is defined by intubation with mechanical ventilation requirement or death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 14 days of inclusion.
We will determine the 95% confidence interval of the AUC of the ROC curve and consider POCUS capacity as clinically relevant if the lower limit of the 95% confidence interval is at least 0.7.
Measured: 14 days
Secondary outcomes (7)
Risk of unfavourable outcome over time
To evaluate, in patients with a confirmed or probable SARS-CoV-2 infection, whether POCUS score performances vary as a function of time, between D1 and D14, and, if so, until which time horizon its performances are clinically relevant.
In this purpose, we will determine the time period for which the lower limit of the 95% confidence interval of the AUC of the POCUS score ROC curve is at least 0.7.
Measured: 14 days
Risk-stratification threshold values
To identify the threshold values of POCUS score to perform risk-stratification in three groups of patients:
- low-risk patients,
- intermediate-risk patients,
- high-risk patients.
In this purpose, we will determine two threshold values on the inflection points of the ROC curve:
- maximizing the specificity for a sensitivity of at least 95%,
- maximizing the sensitivity for a specificity of at least 95%.
Measured: 14 days
Adding value of POCUS score to previous risk-stratification clinical rules
To study the impact of adding the result of POCUS evaluation to several risk-stratification clinical rules for pulmonary infection or sepsis: qSOFA, CRB 65 and CURB 65
In this purpose, we will attribute 0, 1 or 2 points to POCUS score according to the predefined threshold values and will assess :
- sensitivities of qSOFA with and without addition of POCUS score result,
- specificities of qSOFA with and without addition of POCUS score result;
- sensitivities of CRB 65 with and without addition of POCUS score result,
- specificities of CRB 65 with and without addition of POCUS score result;
- sensitivities of CRB 65 with and without addition of POCUS score result,
- specificities of CRB 65 with and without addition of POCUS score result.
Measured: 14 days
POCUS score and patient clinical status at D14
To assess, the capacity of POCUS score at D0 to predict patient clinical status at D14
In this purpose, we will determine the correlation coefficient between the POCUS score at D0 and the clinical status of patients at day 14 according to the WHO Ordinal Scale for Clinical Improvement for COVID-19 patients.
Measured: 14 days
POCUS and CT scan correlation
To study the correlation between POCUS and CT scan assessment of lung damage.
In this purpose, we will determine the intra-class correlation coefficient between POCUS assessment according to the number of affected areas among 12 and CT scan assessment according to the quantification proposed by the French Society of Radiology: 0 - normal; 1 - minor (< 10%), 2 - moderate (10-25%), 3 - important (25-50%), 4 - severe (50-75%), 5 - critical (> 75%)
Measured: 14 days
POCUS versus CT scan risk-stratification performances
To compare the diagnostic performances of POCUS with that of chest computed tomography to identify patients with unfavourable outcome.
In this purpose, we will compare the AUC of the ROC curves of POCUS score and CT scan quantification of lung damage to identify patients with unfavourable outcome (intubation and mechanical ventilation requirement or death)
Measured: 14 days
POCUS score evolution performances
To evaluate, in the subgroup of hospitalized patients having a second chest ultrasonography at Day 5 +/- 3 of inclusion, the performances of the evolution of the POCUS score between the first and the second assessment to identify patients with unfavourable outcome.
In this purpose, we will calculate the delta between the first and second POCUS score and determine the AUC of the ROC curve and its 95% confidence interval.
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 posted8 Apr 2020
- Study start8 Apr 2020
- Primary completion5 Jun 2020
- Study completion23 Jun 2020
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 COVIDStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Philippe LE CONTE, Pr, Principal investigator, University Hospital of NantesThomas FLAMENT, Dr, Principal investigator, University Hospital of ToursLouis SOULAT, Pr, Principal investigator, University Hospital of RennesNicolas MARJANOVIC, Dr, Principal investigator, Poitiers University HospitalFrancis COUTURAUD, Dr, Principal investigator, University Hospital of BrestLaure BAUDIN, Dr, Principal investigator, Hospital of CholetKarim TAZAROURTE, Pr, Principal investigator, Hospices Civils de Lyon (University Hospital of Lyon)Thomas DELOMAS, Dr, Principal investigator, Hospital of Saint-Lô
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338100
- Sponsor's protocol ID
- 2020-A00782-37
- Acronym
- POCUSCO
- Status last verified
- Mar 2020
- First submitted
- 31 Mar 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.
PubMed 32179124Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
PubMed 18403664Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.
PubMed 26298866Morin F, Douillet D, Hamel JF, Rakotonjanahary J, Dupriez F, Savary D, Aube C, Riou J, Dubee V, Roy PM. Point-of-care ultrasonography for risk stratification of non-critical COVID-19 patients on admission (POCUSCO): a study protocol of an international study. BMJ Open. 2021 Feb 10;11(2):e041118. doi: 10.1136/bmjopen-2020-041118.
PubMed 33568367
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point Of Care UltraSonography to Perform Risk-stratification of Patients With Suspected or Confirmed COVID-19 - POCUSCO Study
- ClinicalTrials.gov ID
- NCT04338100
- Acronym / sponsor ID
- POCUSCO / 2020-A00782-37
- Conditions
- COVID, Coronavirus Infection
- Keywords
- COVID-19, SARS-CoV-2, POCUS, Lung ultrasonography, Risk-stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 8 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.
COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue.
While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation.
Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients.
Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date.
Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.
Detailed description
Patients consulting in the emergeny department of participating centres for suspected or confirmed COVID-19 are checked for inclusion and non-inclusion criteria and asked for study participation.
Including patients have point-of-care lung ultrasonography (POCUS) performed within 48 hours following ED admission. The severity of lung damage is assessed using the lung ultrasonography score on 36 points for ARDS (POCUS score).
Apart POCUS score assessment, patients are managed as usual.
If a chest CT scan is performed, its result is collected and, in particular, the quantification of the extent of pulmonary lesions in percentage from 0 to 100%, carried out according to the recommendations of the French Society of Radiology.
For hospitalized patients, if possible, a second chest ultrasonography is performed on Day 5 +/- 3. The extent of lung damage is assessed by the POCUS score.
A follow-up is carried out on day 14 (D14) and the patient's status according to the "Ordinal Scale for Clinical Improvement" for COVID-19 from WHO is recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest Ultrasound | – | Procedure: Follow-up at 14 daysOnly one arm, all included patients having chest ultrasonography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients consulting emergency department with non-severe suspected or confirmed SARS-CoV-2 infection (COVID-19)
Key inclusion criteria (4 listed)
- Patient with COVID-19 confirmed by positive RT-PCR or considered as probable by the in-charge physician,
- ≥18 years old,
- Not requiring respiratory assistance and/or other intensive care
- Not subject to a limitation of active therapeutics
Key exclusion criteria (4 listed)
- History of pneumonectomy
- Any reason making chest ultrasonography impossible
- Any reason making 14-day follow-up impossible
- Patient opposition to research participation.
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 |
|---|---|---|
| Follow-up at 14 daysPoint of care chest ultrasonography and 14-day follow-up to assess the evolution of the infection and care requirement (invasive ventilation or death) | Procedure or surgery | Chest Ultrasound |
Primary outcome
Risk of unfavourable outcome at D14
Time frame: 14 days
To assess, in patients with confirmed or probable SARS-CoV-2 infection, chest ultrasonography capacity, using the POCUS score for ARDS, to identify patients with unfavourable outcome at D14. Unfavourable outcome is defined by intubation with mechanical ventilation requirement or death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 14 days of inclusion. We will determine the 95% confidence interval of the AUC of the ROC curve and consider POCUS capacity as clinically relevant if the lower limit of the 95% confidence interval is at least 0.7.
7 secondary outcomes
Risk of unfavourable outcome over time
Time frame: 14 days
Risk-stratification threshold values
Time frame: 14 days
Adding value of POCUS score to previous risk-stratification clinical rules
Time frame: 14 days
POCUS score and patient clinical status at D14
Time frame: 14 days
POCUS and CT scan correlation
Time frame: 14 days
POCUS versus CT scan risk-stratification performances
Time frame: 14 days
POCUS score evolution performances
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 22 Mar 2022.
- Results publication: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Results publication: PubMed 32179124Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.
- Results publication: PubMed 18403664Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.
- Results publication: PubMed 26298866Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.
- Derived from this study: PubMed 33568367Morin F, Douillet D, Hamel JF, Rakotonjanahary J, Dupriez F, Savary D, Aube C, Riou J, Dubee V, Roy PM. Point-of-care ultrasonography for risk stratification of non-critical COVID-19 patients on admission (POCUSCO): a study protocol of an international study. BMJ Open. 2021 Feb 10;11(2):e041118. doi: 10.1136/bmjopen-2020-041118.
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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.
Philippe LE CONTE, Pr principal investigator
University Hospital of Nantes
Thomas FLAMENT, Dr principal investigator
University Hospital of Tours
Louis SOULAT, Pr principal investigator
University Hospital of Rennes
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Coronavirus Infection, run by University Hospital, Angers at 11 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 4 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: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Belgium. 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?
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?
Risk of unfavourable outcome at D14 (time frame: 14 days). 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 NCT04338100, 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 22 Mar 2022.