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Pneumonia, ViralCortiCORONANCT04619693

Biomarkers for Dexamethasone Response in Sars-Cov-2 / COVID-19 Pneumonia

An observational study of Pneumonia, Viral and SARS-Cov-2, run by University Hospital, Montpellier at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to demonstrate (at the time of admission) biomarkers of interest (Human Plasma BAK125 panel + interferon panel) for dexamethasone responders versus non-responders in SARS-CoV-2 hypoxemic pneumonia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia, Viral, SARS-Cov-2
How many people
79 participants
Where
2 sitesFrance
Study dates
18 Nov 2020to 6 Oct 2021
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: The study population corresponds to patients hospitalized for proven SARS-COV-2 pneumonia with an indication (hypoxemia) for dexamethasone

Who may be able to join

  • Hospitalization for SARS-COV-2 pneumonia
  • SARS-COV-2 infection proven by polymerase chain reaction (Nasopharyngeal or other respiratory sampling (expectoration, tracheal aspiration, bronchoalveolar lavage fluid)
  • Presence of at least one of the following clinical signs of infectious pneumonia: fever (>38°C), cough, dyspnoea, thoracic pain, crackling/rales
  • Presence of at least one of the following on a lung computed tomography scan performed within two days of inclusion/randomisation: uni- or bilateral ground glass opacities, consolidations, alveolar condensations, inter- or intra-lobular reticulations, crazy paving
  • Indication for dexamethasone corticotherapy (defined by the presence of hypoxemia with room-air SpO2 <94% or a requirement for oxygen therapy to maintain Sp02 >94%)

Who cannot join

  • Systemic long-term anti-inflammatory treatment (corticosteroids or anti-interleukins) for chronic disease
  • Systemic corticosteroid treatment in the 15 days preceding the eligibility visit (for disease other than COVID-19)
  • Systemic corticosteroid treatment for COVID-19 started more than 48h before the eligibility visit
  • Absolute contraindication for systemic corticosteroid treatment
  • Aside from the current acute episode, life expectancy of <6 months
  • Patient unable to comply with all study procedures (e.g. contraindication for thoracic scans or bloodwork)
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  • Protected populations according to the French public health code (Pregnant, parturient or lactating women; adults under any form of guardianship; prisoners or persons under any form of judicial protection)
  • Potential interference from other studies (Participation in any clinical trial of an investigational agent or procedure within one month prior to screening or during the study; exclusion period determined by another study.)
  • It is impossible to correctly inform the patient (e.g. language barrier)
  • Absence of free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)
  • Non-beneficiary of the French social security, single-payer health insurance system

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Clinique du Parc

    Montpellier

  • University Hospitals of Montpellier

    Montpellier

Other trials in France

About this study

Official title: Determination of Biomarkers for the Prediction of Dexamethasone Response in Sars-Cov-2 / COVID-19 Pneumonia

The primary objective of this study is to demonstrate (at the time of admission) biomarkers of interest (Human Plasma BAK125 panel + interferon panel) for dexamethasone responders versus non-responders in SARS-CoV-2 hypoxemic pneumonia.

The secondary objectives are to describe and compare between groups:

  • The number of days without mechanical ventilation
  • The need for mechanical ventilation
  • 28-day mortality
  • Progression towards acute respiratory distress syndrome (ARDS)
  • Change in the qSOFA score
  • Length of hospitalization
  • The change in the extent of lesions on thoracic computed tomography scan between inclusion and D7 (or the day of discharge from hospital if <D7)
  • Change in biomarkers on D0, D2, D4, D7 (NFS, liver tests (ASAT, ALAT), Creatinine, Albumin, CRP, D-dimers, Ferritin, LDH, lymphocyte phenotyping)
  • Demonstrate other biomarkers of interest from the usual management (NFS, liver function tests (ASAT, ALAT), Creatinine, Albumin, CRP, D-dimers, Ferritin, LDH, lymphocyte phenotyping)
  • Change in biomarkers evaluated by mass spectrometry (on a blood sample) on D0 and D7 +/- 2 days
  • The initial viral load (within 48 hours preceding D0) and at D7 of inclusion estimated from the nasopharyngeal SARS-CoV-2 RT-PCR
  • Initial SARS-CoV-2 serology and on D7 from inclusion
  • The A38G polymorphism of the gene coding for Club Cell Secretory Protein (CCSP) for each patient
  • Short-term complications related to corticosteroid therapy
  • The quantitative and qualitative impact of corticosteroid therapy on lymphocytes from patients with COVID-19.
Read the detailed description

This is a prospective multicenter cohort of patients treated with the usual standard of care including systemic corticosteroid therapy with dexamethasone 6 mg / day.

INCLUSION (D0): The patients are examined on the day of their hospital admission. After an initial eligibility check and if interest is expressed by the patient, a specific inclusion visit is carried out.

FOLLOW-UP: Patients are clinically evaluated at least twice a day (Clinical examination, SpO2, vital signs) during hospitalization. Chest computed tomography and SARS-CoV-2 serology are performed on D0. Viral load is evaluated by the polymerase chain reaction which allowed the diagnosis of covid-19 in the 48 hours preceding D0 and on D7. The evaluation of conventional biomarkers of interest (blood count, hepatic assessment (ASAT, ALAT), serum creatinine, albuminemia, CRP, D-Dimers, LDH, Ferritin) are carried out on D0 (before the 1st dose of corticosteroids), D2 , J4 and J7. The evaluation of biomarkers of interest evaluated by mass spectrometry is carried out on D0 and D7 +/- 2 days.

A follow-up call on D28 is carried out (telephone call, collection of vital status and hospitalizations).

Keywords
hypoxemic pneumonia, corticosteroid, glucocorticosteroid, systemic corticosteroid, COVID-19
Medical subject headings
Pneumonia, Viral, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04619693
Study groupRoleWhat they receive
The study populationThe study population corresponds to patients hospitalized for proven SARS-COV-2 pneumonia with an indication (hypoxemia) for dexamethasone (see eligibility criteria)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment failure (yes/no)

    Treatment failure is defined as the need to transfer the patient to intensive care for mechanical ventilation.

    Measured: Hospital discharge (expected maximum of 28 days)

Secondary outcomes (154)

  1. Human Plasma BAK-125 proteomics profile

    PeptiQuantTM Plus, Human Plasma BAK 125, Cambridge Isotope Laboratories, Inc

    Measured: Baseline (day 0)

  2. Human Plasma BAK-125 proteomics profile

    PeptiQuantTM Plus, Human Plasma BAK 125, Cambridge Isotope Laboratories, Inc

    Measured: Day 7

  3. Circulating blood interferon level

    Measured: Baseline (day 0)

  4. Circulating blood interferon level

    Measured: Day 7

  5. A vector of repeated measures of SpO2

    Measured at least twice per day throughout the initial hospitalization period.

    Measured: Throughout initial hospitalization (expected maximum of 28 days)

  6. A vector of repeated measures of FiO2

    Measured at least twice per day throughout the initial hospitalization period.

    Measured: Throughout initial hospitalization (expected maximum of 28 days)

  7. A vector of repeated measures of temperature (°C)

    Measured at least twice per day throughout the initial hospitalization period.

    Measured: Throughout initial hospitalization (expected maximum of 28 days)

  8. A vector of repeated measures of respiratory rate (cycles per minute)

    Measured at least twice per day throughout the initial hospitalization period.

    Measured: Throughout initial hospitalization (expected maximum of 28 days)

  9. A vector of repeated measures of pulse (bpm)

    Measured at least twice per day throughout the initial hospitalization period.

    Measured: Throughout initial hospitalization (expected maximum of 28 days)

  10. A vector of repeated measures of systolic blood pressure (mmHg)

    Measured at least twice per day throughout the initial hospitalization period.

    Measured: Throughout initial hospitalization (expected maximum of 28 days)

  11. A vector of repeated measures of diastolic blood pressure (mmHg)

    Measured at least twice per day throughout the initial hospitalization period.

    Measured: Throughout initial hospitalization (expected maximum of 28 days)

  12. A vector of repeated measures of capillary glycemia (g/L)

    Capillary glycemia will be measured at least twice per day throughout the initial hospitalization period.

    Measured: Throughout initial hospitalization (expected maximum of 28 days)

  13. A vector of repeated measures of the qSOFA score

    The Quick Sequential Organ Failure Assessment (qSOFA) score will be assessed at least twice per day throughout the initial hospitalization period.

    The quick Sepsis-related organ failure assessment (qSOFA) score ranges from 0 to 3 points, with '3' indicating the worst health state. It uses three criteria, assigning one point for low blood pressure (systolic blood pressure ≤100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation.

    Measured: Throughout initial hospitalization (expected maximum of 28 days)

  14. Hemoglobin

    Measured: Baseline (day 0)

  15. Hemoglobin

    Measured: Day 2

  16. Hemoglobin

    Measured: Day 4

  17. Hemoglobin

    Measured: Day 7 (or day of discharge if before day 7)

  18. Platelet count

    Measured: Baseline (day 0)

  19. Platelet count

    Measured: Day 2

  20. Platelet count

    Measured: Day 4

  21. Platelet count

    Measured: Day 7 (or day of discharge if before day 7)

  22. White blood cell count

    Measured: Baseline (day 0)

  23. White blood cell count

    Measured: Day 2

  24. White blood cell count

    Measured: Day 4

  25. White blood cell count

    Measured: Day 7 (or day of discharge if before day 7)

  26. Neutrophil percentage

    Measured: Baseline (day 0)

  27. Neutrophil percentage

    Measured: Day 2

  28. Neutrophil percentage

    Measured: Day 4

  29. Neutrophil percentage

    Measured: Day 7 (or day of discharge if before day 7)

  30. Eosinophil percentage

    Measured: Baseline (day 0)

  31. Eosinophil percentage

    Measured: Day 2

  32. Eosinophil percentage

    Measured: Day 4

  33. Eosinophil percentage

    Measured: Day 7 (or day of discharge if before day 7)

  34. Basophil percentage

    Measured: Baseline (day 0)

  35. Basophil percentage

    Measured: Day 2

  36. Basophil percentage

    Measured: Day 4

  37. Basophil percentage

    Measured: Day 7 (or day of discharge if before day 7)

  38. Lymphocyte percentage

    Measured: Baseline (day 0)

  39. Lymphocyte percentage

    Measured: Day 2

  40. Lymphocyte percentage

    Measured: Day 4

  41. Lymphocyte percentage

    Measured: Day 7 (or day of discharge if before day 7)

  42. Monocyte percentage

    Measured: Baseline (day 0)

  43. Monocyte percentage

    Measured: Day 2

  44. Monocyte percentage

    Measured: Day 4

  45. Monocyte percentage

    Measured: Day 7 (or day of discharge if before day 7)

  46. Prothrombin rate (%)

    Measured: Baseline (day 0)

  47. Prothrombin rate (%)

    Measured: Day 2

  48. Prothrombin rate (%)

    Measured: Day 4

  49. Prothrombin rate (%)

    Measured: Day 7 (or day of discharge if before day 7)

  50. Activated partial thromboplastin time ratio

    Measured: Baseline (Day 0)

  51. Activated partial thromboplastin time ratio

    Measured: Day 2

  52. Activated partial thromboplastin time ratio

    Measured: Day 4

  53. Activated partial thromboplastin time ratio

    Measured: Day 7 (or day of discharge if before day 7)

  54. Fibrinogen (g/L)

    Measured: Baseline (Day 0)

  55. Fibrinogen (g/L)

    Measured: Day 2

  56. Fibrinogen (g/L)

    Measured: Day 4

  57. Fibrinogen (g/L)

    Measured: Day 7 (or day of discharge if before day 7)

  58. D-Dimers (μg/mL)

    Measured: Baseline (Day 0)

  59. D-Dimers (μg/mL)

    Measured: Day 2

  60. D-Dimers (μg/mL)

    Measured: Day 4

  61. D-Dimers (μg/mL)

    Measured: Day 7 (or day of discharge if before day 7)

  62. Aspartate aminotransferase (ASAT; UI/L)

    Measured: Baseline (Day 0)

  63. Aspartate aminotransferase (ASAT; UI/L)

    Measured: Day 2

  64. Aspartate aminotransferase (ASAT; UI/L)

    Measured: Day 4

  65. Aspartate aminotransferase (ASAT; UI/L)

    Measured: Day 7 (or day of discharge if before day 7)

  66. Alanine aminotransferase (ALAT; UI/L)

    Measured: Baseline (Day 0)

  67. Alanine aminotransferase (ALAT; UI/L)

    Measured: Day 2

  68. Alanine aminotransferase (ALAT; UI/L)

    Measured: Day 4

  69. Alanine aminotransferase (ALAT; UI/L)

    Measured: Day 7 (or day of discharge if before day 7)

  70. Glucose (mmol/L)

    Measured: Baseline (Day 0)

  71. Glucose (mmol/L)

    Measured: Day 2

  72. Glucose (mmol/L)

    Measured: Day 4

  73. Glucose (mmol/L)

    Measured: Day 7 (or day of discharge if before day 7)

  74. Glycated haemoglobin (HbA1c; %)

    Measured: Baseline (Day 0)

  75. Glycated haemoglobin (HbA1c; %)

    Measured: Day 2

  76. Glycated haemoglobin (HbA1c; %)

    Measured: Day 4

  77. Glycated haemoglobin (HbA1c; %)

    Measured: Day 7 (or day of discharge if before day 7)

  78. Urea (mmol/L)

    Measured: Baseline (Day 0)

  79. Urea (mmol/L)

    Measured: Day 2

  80. Urea (mmol/L)

    Measured: Day 4

  81. Urea (mmol/L)

    Measured: Day 7 (or day of discharge if before day 7)

  82. Creatinine (µmol/L)

    Measured: Baseline (Day 0)

  83. Creatinine (µmol/L)

    Measured: Day 2

  84. Creatinine (µmol/L)

    Measured: Day 4

  85. Creatinine (µmol/L)

    Measured: Day 7 (or day of discharge if before day 7)

  86. Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

    Measured: Baseline (Day 0)

  87. Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

    Measured: Day 2

  88. Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

    Measured: Day 4

  89. Estimated glomerular filtration rate (eGFR, ml/min/1.73m^2)

    Measured: Day 7 (or day of discharge if before day 7)

  90. Albumin (g/L)

    Measured: Baseline (Day 0)

  91. Albumin (g/L)

    Measured: Day 2

  92. Albumin (g/L)

    Measured: Day 4

  93. Albumin (g/L)

    Measured: Day 7 (or day of discharge if before day 7)

  94. C reactive protein (CRP, mg/L)

    Measured: Baseline (Day 0)

  95. C reactive protein (CRP, mg/L)

    Measured: Day 2

  96. C reactive protein (CRP, mg/L)

    Measured: Day 4

  97. C reactive protein (CRP, mg/L)

    Measured: Day 7 (or day of discharge if before day 7)

  98. Lactate dehydrogenase (LDH, UI/L)

    Measured: Baseline (Day 0)

  99. Lactate dehydrogenase (LDH, UI/L)

    Measured: Day 2

  100. Lactate dehydrogenase (LDH, UI/L)

    Measured: Day 4

  101. Lactate dehydrogenase (LDH, UI/L)

    Measured: Day 7 (or day of discharge if before day 7)

  102. Hypersensitive troponin T (µg/L)

    Measured: Baseline (Day 0)

  103. Hypersensitive troponin T (µg/L)

    Measured: Day 2

  104. Hypersensitive troponin T (µg/L)

    Measured: Day 4

  105. Hypersensitive troponin T (µg/L)

    Measured: Day 7 (or day of discharge if before day 7)

  106. Ferritin (µg/L)

    Measured: Baseline (Day 0)

  107. Ferritin (µg/L)

    Measured: Day 2

  108. Ferritin (µg/L)

    Measured: Day 4

  109. Ferritin (µg/L)

    Measured: Day 7 (or day of discharge if before day 7)

  110. CD4 cell count

    CD4 refers to cluster of differentiation 4.

    Measured: Baseline (Day 0)

  111. CD4 cell count

    CD4 refers to cluster of differentiation 4.

    Measured: Day 2

  112. CD4 cell count

    CD4 refers to cluster of differentiation 4.

    Measured: Day 4

  113. CD4 cell count

    CD4 refers to cluster of differentiation 4.

    Measured: Day 7 (or day of discharge if before day 7)

  114. CD8 cell count

    CD8 refers to cluster of differentiation 8.

    Measured: Baseline (Day 0)

  115. CD8 cell count

    CD8 refers to cluster of differentiation 8.

    Measured: Day 2

  116. CD8 cell count

    CD8 refers to cluster of differentiation 8.

    Measured: Day 4

  117. CD8 cell count

    CD8 refers to cluster of differentiation 8.

    Measured: Day 7 (or day of discharge if before day 7)

  118. Natural killer cell count

    Measured: Baseline (Day 0)

  119. Natural killer cell count

    Measured: Day 2

  120. Natural killer cell count

    Measured: Day 4

  121. Natural killer cell count

    Measured: Day 7 (or day of discharge if before day 7)

  122. Activated T cell percentage

    Measured: Baseline (Day 0)

  123. Activated T cell percentage

    Measured: Day 2

  124. Activated T cell percentage

    Measured: Day 4

  125. Activated T cell percentage

    Measured: Day 7 (or day of discharge if before day 7)

  126. Change in SARS-CoV-2 real-time polymerase chain reaction cycle threshold

    Measured: Baseline to day 7 (or day of discharge if before day 7)

  127. Change in SARS-CoV-2 IgG serology (% of control signal = PCS)

    Measured: Baseline to day 7 (or day of discharge if before day 7)

  128. Change in SARS-CoV-2 IgM serology (% of control signal = PCS)

    Measured: Baseline to day 7 (or day of discharge if before day 7)

  129. Change from positivity at baseline to negativity at Day 7: yes/no for SARS-CoV-2 real time polymerase chain reaction

    Measured: Day 7 (or day of discharge if before day 7)

  130. Change from positivity at baseline to negativity at Day 7: yes/no for SARS-CoV-2 IgG serology

    Measured: Day 7 (or day of discharge if before day 7)

  131. Change from positivity at baseline to negativity at Day 7: yes/no for SARS-CoV-2 IgM serology

    Measured: Day 7 (or day of discharge if before day 7)

  132. Reduction in the extent of lesions visualized on computed tomography chest scan: yes/no for grand glass opacities

    A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment

    Measured: Day 7 (or day of discharge if before day 7) +- 1 day of leeway for logistics

  133. Reduction in the extent of lesions visualized on computed tomography chest scan: yes/no for consolidation

    A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment

    Measured: Day 7 (or day of discharge if before day 7) +- 1 day of leeway for logistics

  134. Reduction in the extent of lesions visualized on computed tomography chest scan: yes/no for total lesions

    A reduction in the extent of lesions is defined by a ⩾20% reduction in parenchymal involvement compared to the initial assessment

    Measured: Day 7 (or day of discharge if before day 7) +- 1 day of leeway for logistics

  135. Requirement for low flow oxygen therapy during the initial hospitalisation: yes/no

    Measured: Day of hospital discharge (expected maximum of 28 days)

  136. Requirement for high flow oxygen therapy during the initial hospitalisation: yes/no

    Measured: Day of hospital discharge (expected maximum of 28 days)

  137. Requirement for non-invasive ventilation during the initial hospitalisation: yes/no

    Measured: Day of hospital discharge (expected maximum of 28 days)

  138. Requirement for invasive ventilation during the initial hospitalisation: yes/no

    Measured: Day of hospital discharge (expected maximum of 28 days)

  139. Requirement for dialysis during the initial hospitalisation: yes/no

    Measured: Day of hospital discharge (expected maximum of 28 days)

  140. Requirement for extracorporeal membrane oxygenation during the initial hospitalisation: yes/no

    Measured: Day of hospital discharge (expected maximum of 28 days)

  141. Classification of acute respiratory distress syndrome (ARDS) according to the Berlin criteria during initial hospitalization: absent, mild, moderate or severe

    Measured: Day of hospital discharge (expected maximum of 28 days)

  142. Length of stay (hours) in intensive care

    Measured: Day of hospital discharge (expected maximum of 28 days)

  143. Length of stay (hours) in hospital

    Measured: Day of hospital discharge (expected maximum of 28 days)

  144. Days alive and without low flow oxygen therapy

    Measured: Day 28

  145. Days alive and without high flow oxygen therapy

    Measured: Day 28

  146. Days alive and without any oxygen therapy

    Measured: Day 28

  147. Days alive and without non-invasive ventilation

    Measured: Day 28

  148. Days alive and without invasive ventilation

    Measured: Day 28

  149. Days alive and without extracorporeal membrane oxygenation

    Measured: Day 28

  150. Days alive and without intensive care

    Measured: Day 28

  151. Days alive and without hospitalisation

    Measured: Day 28

  152. Mortality

    Measured: Day of hospital discharge (expected maximum of 28 days)

  153. Mortality

    Measured: Day 28

  154. Club cell secrectory protein polymorphism A38G

    Measured: Between day 0 and day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study start18 Nov 2020
  3. Primary completion6 Oct 2021
  4. Study completion6 Oct 2021

Why it stopped: Difficulty of recruitment with the increase of the vaccination against COVID19

Resources

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
Prospective
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619693
Sponsor's protocol ID
RECHMPL20_0292
Other IDs
2020-A0206-33, PHRCI-20-013
Acronym
CortiCORONA
Status last verified
Dec 2021
First submitted
2 Nov 2020
Last updated
17 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission Nationale de l'Informatique et des Libertés : https://www.cnil.fr/professionnel).

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia, Viral and SARS-Cov-2, run by University Hospital, Montpellier at 2 sites 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 5 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: stopped early, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study was stopped early (reason given: Difficulty of recruitment with the increase of the vaccination against COVID19). 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?

Treatment failure (yes/no) (time frame: Hospital discharge (expected maximum of 28 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 NCT04619693.

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 17 Dec 2021.

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