Methylpredniprednisolone on ICU patients with COVID-19 on mechanical ventilation

Evaluation of Methylprednisone use in patients with Acute Respiratory Syndrome by COVID-19

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-58q5y2m

Enrollment

Unknown

Registered

2023-01-24

Start date

2020-07-07

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. The patients were randomized into two groups 1:1 by the pharmacist responsible for the unit. The others health professionals were

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Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: over 18 years old ; COVID-19 ; mechanical ventilation within 24 hours; Acute Respiratory Distress Syndrome

Exclusion criteria

Exclusion criteria: pregnancy; active lactation; history of methylprednisolone allergy; corticosteroid use in the past 15 days; informed consent refusal; expected death in the next 24 hours

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: A mortality reduction of 25.56% is expected to be found in patients with COVID-19 pneumonia with the use of methylprednisolone.;Outcome found 1: There was no significant difference in all-cause mortality at 28 days (24.1% in the methylprednisolone group vs 29.6% in the stand of care alone group, p = 0.512)	—

Secondary

Measure	Time frame
Outcome found 2: The mean days of ICU stay was lower in the methylprednisolone group, 12,5 days + 10.45 vs 18.76 + 15.1, p = 0.043. There wasn’t significant difference between groups with regard length of hospital stay, 23 days, 15.8 – 30.1 vs 26 days, 22.3 – 29.6, IC 95%, p = 0.293). Although there is no difference between the hospital stay, the discharge rate in the 28 -days was higher in the methylprednisolone group than in the placebo group, (48.3% in the methylprednisolone group vs 27.8% in the placebo group, p = 0.026). There wasn’t significant difference in all-cause hospital mortality (32.8% in the methylprednisolone group and 48.1% in the placebo group, p = 0.097). The median of the days in mechanical ventilation was also significant lower in the methylprednisolone group than in the placebo group, 6 days vs 14 days: IC 95%, p = 0.012. There was significant difference in the number of extubated patients (67.2% in the methylprednisolone group vs 48.1% in the placebo group, p = 0.042). The number of extubated patients were counted as extubated for the first time with no extubation failure. The number of tracheostomies was lower in the group methylprednisolone, five patients in the methylprednisolone group and fourteen in the group placebo (p = 0.015). There were no differences in adverse event between the groups: blood infections (10.3%in methylprednisolone group vs 16.7% in placebo group, p = 0.326), and pneumonia associated mechanical ventilation (37.9% in methylprednisolone group vs 51.9% in placebo group, p = 0.139). ;Expected outcome2: it is expected to find a reduction in the time of mechanical ventilation; a reduction in the length of stay in the intensive care unit; a reduction in the length of hospital stay; a reduction in the number of tracheostomies; an increase in the number of extubations.	—

Measure

Time frame

Outcome found 2: The mean days of ICU stay was lower in the methylprednisolone group, 12,5 days + 10.45 vs 18.76 + 15.1, p = 0.043. There wasn’t significant difference between groups with regard length of hospital stay, 23 days, 15.8 – 30.1 vs 26 days, 22.3 – 29.6, IC 95%, p = 0.293). Although there is no difference between the hospital stay, the discharge rate in the 28 -days was higher in the methylprednisolone group than in the placebo group, (48.3% in the methylprednisolone group vs 27.8% in the placebo group, p = 0.026). There wasn’t significant difference in all-cause hospital mortality (32.8% in the methylprednisolone group and 48.1% in the placebo group, p = 0.097). The median of the days in mechanical ventilation was also significant lower in the methylprednisolone group than in the placebo group, 6 days vs 14 days: IC 95%, p = 0.012. There was significant difference in the number of extubated patients (67.2% in the methylprednisolone group vs 48.1% in the placebo group, p = 0.042). The number of extubated patients were counted as extubated for the first time with no extubation failure. The number of tracheostomies was lower in the group methylprednisolone, five patients in the methylprednisolone group and fourteen in the group placebo (p = 0.015). There were no differences in adverse event between the groups: blood infections (10.3%in methylprednisolone group vs 16.7% in placebo group, p = 0.326), and pneumonia associated mechanical ventilation (37.9% in methylprednisolone group vs 51.9% in placebo group, p = 0.139). ;Expected outcome2: it is expected to find a reduction in the time of mechanical ventilation; a reduction in the length of stay in the intensive care unit; a reduction in the length of hospital stay; a reduction in the number of tracheostomies; an increase in the number of extubations.

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Countries

Brazil

Contacts

Public ContactEllen Oliveira

Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo

lenna7772003@yahoo.com+55 (11) 93338-8188

Outcome results

None listed

Source: REBEC (via WHO ICTRP)