Trial · NCT04323592
Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome
NCT04323592, Completed, University of Trieste; results first posted 2020-06-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome. Trials, record NCT04323592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04323592
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome
- NCT number
- NCT04323592
- Status
- Completed
- Enrollment
- 173 participants, actual
- Lead sponsor
- University of Trieste
- Conditions
- Severe Acute Respiratory Syndrome (SARS) Pneumonia, Coronavirus Infections, ARDS, Human
- Interventions
- Methylprednisolone, standard care
- First posted
- 2020-03-26
- Last updated
- 2020-06-24
- Results first posted
- 2020-06-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28 | 28 days | We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation. |
| Primary | In-hospital Death Within 28 Days | 28 days | We reported below the number of participants who died within 28 days, during the hospital stay. |
| Primary | Admission to Intensive Care Unit (ICU) | 28 days | We reported below the number of participants admitted to ICU within 28 days. |
| Primary | Endotracheal Intubation (Invasive Mechanical Ventilation) | 28 days | We reported below the number of participants who needed endotracheal intubation during ICU admission |
| Secondary | Change in C-reactive Protein (CRP) | 7 days | Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement. |
| Secondary | Number of Days Free From Mechanical Ventilation | 28 days | number of days free from mechanical ventilation (both invasive and non-invasive) by day 28 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28 | 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | In-hospital Death Within 28 Days | 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Admission to Intensive Care Unit (ICU) | 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Endotracheal Intubation (Invasive Mechanical Ventilation) | 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in C-reactive Protein (CRP) | 7 days | mg/L | MEAN | |
| SECONDARY | Number of Days Free From Mechanical Ventilation | 28 days | days | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28 | Exposed to Methylprednisolone | 19 | Participants | ||
| Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28 | Non-exposed to Methylprednisolone | 40 | Participants | ||
| In-hospital Death Within 28 Days | Exposed to Methylprednisolone | 6 | Participants | ||
| In-hospital Death Within 28 Days | Non-exposed to Methylprednisolone | 21 | Participants | ||
| Admission to Intensive Care Unit (ICU) | Exposed to Methylprednisolone | 15 | Participants | ||
| Admission to Intensive Care Unit (ICU) | Non-exposed to Methylprednisolone | 27 | Participants | ||
| Endotracheal Intubation (Invasive Mechanical Ventilation) | Exposed to Methylprednisolone | 15 | Participants | ||
| Endotracheal Intubation (Invasive Mechanical Ventilation) | Non-exposed to Methylprednisolone | 26 | Participants | ||
| Change in C-reactive Protein (CRP) | Exposed to Methylprednisolone | -82.08 | Standard Deviation 28.24 | mg/L | |
| Change in C-reactive Protein (CRP) | Non-exposed to Methylprednisolone | -34.34 | Standard Deviation 66.64 | mg/L |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exposed to Methylprednisolone | 83 | |
| Overall Study | STARTED | Non-exposed to Methylprednisolone | 90 | |
| Overall Study | COMPLETED | Exposed to Methylprednisolone | 83 | |
| Overall Study | COMPLETED | Non-exposed to Methylprednisolone | 90 | |
| Overall Study | NOT COMPLETED | Exposed to Methylprednisolone | 0 | |
| Overall Study | NOT COMPLETED | Non-exposed to Methylprednisolone | 0 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bacterial superinfection | General disorders | Exposed to Methylprednisolone | 1 | 83 | 1 |
| other | Bacterial superinfection | General disorders | Non-exposed to Methylprednisolone | 1 | 90 | 1 |
| other | Agitation | Psychiatric disorders | Exposed to Methylprednisolone | 9 | 83 | 9 |
| other | Agitation | Psychiatric disorders | Non-exposed to Methylprednisolone | 2 | 90 | 2 |
| other | Hyperglycemia | Endocrine disorders | Exposed to Methylprednisolone | 8 | 83 | 8 |
| other | Hyperglycemia | Endocrine disorders | Non-exposed to Methylprednisolone | 0 | 90 | 0 |
| other | Hypokalemia | General disorders | Exposed to Methylprednisolone | 6 | 83 | 6 |
| other | Hypokalemia | General disorders | Non-exposed to Methylprednisolone | 13 | 90 | 13 |
| other | Pneumothorax | Respiratory, thoracic and mediastinal disorders | Exposed to Methylprednisolone | 1 | 83 | 1 |
| other | Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-exposed to Methylprednisolone | 0 | 90 | 0 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exposed to Methylprednisolone | 9 | 83 |
| Total, all-cause mortality | Non-exposed to Methylprednisolone | 24 | 90 |
| Total, other adverse events | Exposed to Methylprednisolone | 23 | 83 |
| Total, other adverse events | Non-exposed to Methylprednisolone | 21 | 90 |
| Total, serious adverse events | Exposed to Methylprednisolone | 6 | 83 |
| Total, serious adverse events | Non-exposed to Methylprednisolone | 9 | 90 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Exposed to Methylprednisolone vs Non-exposed to Methylprednisolone: Endotracheal Intubation (Invasive Mechanical Ventilation) | Trial comparisons |
| Exposed to Methylprednisolone vs Non-exposed to Methylprednisolone: In-hospital Death Within 28 Days | Trial comparisons |
| Exposed to Methylprednisolone vs Non-exposed to Methylprednisolone: Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28 | Trial comparisons |
| Exposed to Methylprednisolone vs Non-exposed to Methylprednisolone: deaths from any cause | Trial comparisons |
| Exposed to Methylprednisolone vs Non-exposed to Methylprednisolone: Admission to Intensive Care Unit (ICU) | Trial comparisons |
| Exposed to Methylprednisolone vs Non-exposed to Methylprednisolone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04323592
GET https://conductscience.org/api/trials/v1/NCT04323592/events?page=2