MP-C19: Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome

Sponsor
University of Trieste (Other)
Overall Status
Completed
CT.gov ID
NCT04323592
Collaborator
(none)
173
1
1.6
109.7

Study Details

Study Description

Brief Summary

COVID-19 infection is overwhelming Italian healthcare. There is an urgent need for a solution to the lack of ICU beds and increasing deaths day after day.

A recent retrospective Chinese paper (JAMA Intern Med, online March 13, 2020) showed impressive positive effect of methylprednisolone (MP) on survival of SARS-CoV-2 critically ill patients. Moreover, the Italian Infectious Disease leading institution guidelines for COVID-19 clinical management included as an option for patients with "incipient worsening of respiratory functions" methylprednisolone treatment at an approximate dose of 80mg.

The main objective of this multi-centre observational trial is to analyse the association of low dose prolonged infusion of methylprednisolone (MP) for patients with severe acute respiratory syndrome with composite primary end-point (ICU referral, need for intubation, in-hospital death at day 28).

Condition or Disease Intervention/Treatment Phase

Detailed Description

Comparison of two groups of patients SARS-CoV-2 positive with severe acute respiratory syndrome:

  1. Exposed to low prolonged doses of Methylprednisolone

  2. Not exposed to corticosteroids (standard of care alone)

The two group will be weighted by means of a propensity score according to:
  1. Sex

  2. Age

  3. C-reactive protein (CRP) at baseline

  4. Sequential Organ Failure Assessment (SOFA) score at baseline

  5. PaO2/FiO2 ratio at baseline (ratio of arterial oxygen partial pressure to fractional inspired oxygen)

Anti-viral agents, chloroquine, respiratory support (any), and antibiotics (any) are allowed in each study group. Corticosteroids use, other than per-protocol Methylprednisolone in the exposed group is a reason for dropout.

  1. The exposed group is treated with Methylprednisolone at study entry (baseline) according to a protocol based on the Italian national recommendations for COVID-19 management: a loading dose of 80 mg IV, followed by an infusion of 80 mg/day in 240 mL normal saline at 10 mL/h. The infusion is continued for at least eight days and until achieving either a PaO2:FiO2 > 350 mmHg or a CRP < 20 mg/L. Treatment is then switched to oral administration of Methylprednisolone 16 mg or 20 mg IV twice daily until CRP returns to < 20% of normal range and/or PaO2:FiO2 > 400 or SatHbO2 ≥ 95%. The decision to apply the protocol to Covid-19 is left to the discretion of the treating team for each individual patient.

  2. Unexposed patients will be selected from concurrent consecutive COVID-19 patients with the same inclusion and exclusion criteria and blinded to outcome data.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
173 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prolonged Low Doses of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome
Actual Study Start Date :
Mar 23, 2020
Actual Primary Completion Date :
May 10, 2020
Actual Study Completion Date :
May 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Exposed to Methylprednisolone

Consecutive SARS-CoV-2 positive patients with severe acute respiratory syndrome treated with methylprednisolone (MP) at low prolonged dose, fulfilling inclusion and exclusion criteria.

Drug: Methylprednisolone
Usual standard of care plus Methylprednisolone (MP) 80 mg/kg IV bolus, followed by MP infusion of 80 mg/day in 240 mL normal saline at 10 mL/h. The infusion is continued for at least eight days and until achieving either a PaO2:FiO2 > 350 mmHg or a CRP < 20 mg/L. Treatment is then switched to oral administration of Methylprednisolone 16 mg or 20 mg IV twice daily until CRP returns to < 20% of normal range and/or PaO2:FiO2 > 400 or SatHbO2 ≥ 95%. The decision to apply the protocol to Covid-19 is left to the discretion of the treating team for each individual patient.

Other: standard care
usual standard of care: oxygen therapy (regular or high-flow) and monitoring empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) ECMO when needed and available pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins

Non-exposed to Methylprednisolone

Concurrent patients fulfilling the same inclusion and exclusion criteria, never treated with steroids.

Other: standard care
usual standard of care: oxygen therapy (regular or high-flow) and monitoring empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) ECMO when needed and available pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. In-hospital Death Within 28 Days [28 days]

    We reported below the number of participants who died within 28 days, during the hospital stay.

  3. Admission to Intensive Care Unit (ICU) [28 days]

    We reported below the number of participants admitted to ICU within 28 days.

  4. Endotracheal Intubation (Invasive Mechanical Ventilation) [28 days]

    We reported below the number of participants who needed endotracheal intubation during ICU admission

Secondary Outcome Measures

  1. 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.

  2. Number of Days Free From Mechanical Ventilation [28 days]

    number of days free from mechanical ventilation (both invasive and non-invasive) by day 28

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. SARS-CoV-2 positive

  2. Age >17 years and < 80 years

  3. P/F < 250 mmHg

  4. Bilateral pneumonia (infiltrates/interstitial)

  5. CRP >10mg/dL (or >100mg/L)

  6. Alternatively to 4-5-6 criteria a diagnosis of ARDS according to the Berlin definition (Ranieri M, et al. JAMA 2012)

Exclusion Criteria:
  • Heart failure as predominant cause of acute respiratory failure

  • Decompensated liver cirrhosis

  • Cancer

  • Organ transplantation

  • HIV+

  • dialysis

  • long-term oxygen therapy, home mechanical ventilation

  • Idiopathic pulmonary fibrosis

  • Progressive neuromuscular disorders (e.g. Duchenne, Pompe, ALS)

  • Dementia or decompensated psychiatric diseases

  • immunosuppressive treatments

  • Chronic use of corticosteroids

  • Use of Tocilizumab

  • pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marco Confalonieri Trieste TS Italy 34149

Sponsors and Collaborators

  • University of Trieste

Investigators

  • Principal Investigator: Marco Confalonieri, MD, University of Trieste

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
marco confalonieri, Head of Pulmonology and Critical care Dept., University of Trieste
ClinicalTrials.gov Identifier:
NCT04323592
Other Study ID Numbers:
  • MP-19 023_2020
First Posted:
Mar 26, 2020
Last Update Posted:
Jun 24, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by marco confalonieri, Head of Pulmonology and Critical care Dept., University of Trieste
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Arm/Group Description SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose. Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached. Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters: CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control. standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive)pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins
Period Title: Overall Study
STARTED 83 90
COMPLETED 83 90
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Exposed to Methylprednisolone Non-exposed to Methylprednisolone Total
Arm/Group Description SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at low prolonged dose. At admission, inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering until normal CRP values (+20%) are reached. Methylprednisolone: Methylprednisolone given at low prolonged dose infusion after initial 80mg iv bolus at admission followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description standard care: usual standard of care: oxygen therapy (regular or high-flow) and monitoring empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) ECMO when needed and available pronati Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters: CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control. standard care: usual standard of care: oxygen therapy (regular or high-flow) and monitoring empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) ECMO when needed and available pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins Total of all reporting groups
Overall Participants 83 90 173
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
35
42.2%
34
37.8%
69
39.9%
>=65 years
48
57.8%
56
62.2%
104
60.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
64.39
(10.73)
67.08
(8.24)
65.79
(9.58)
Sex: Female, Male (Count of Participants)
Female
29
34.9%
24
26.7%
53
30.6%
Male
54
65.1%
66
73.3%
120
69.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (Count of Participants)
Italy
83
100%
90
100%
173
100%
C-reactive Protein (mg/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/L]
136.92
(72.57)
148.64
(75.59)
143.01
(74.17)
PaO2/FiO2 (ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ratio]
152.02
(49.84)
151.01
(60.26)
151.50
(55.35)
Sequential Organ Failure Assessment (SOFA) Score (score) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [score]
3
3
3
Lactates (mmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/L]
1.76
(1.97)
1.34
(0.51)
1.52
(1.32)
Lymphocytes (cells/uL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells/uL]
622.28
(650.62)
954.5
(914.7)
938.94
(797.81)
D-dimer (ug/L Fibrinogen Equivalent Units (FEU)) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [ug/L Fibrinogen Equivalent Units (FEU)]
780
890
813
lactate dehydrogenase (LDH) (U/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [U/L]
380
(132.93)
413.06
(143.83)
396.41
(138.96)
Respiratory rate (Breaths per minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Breaths per minute]
23.74
(5.95)
25.27
(6.76)
24.55
(6.41)

Outcome Measures

1. Primary Outcome
Title Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28
Description We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation.
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Arm/Group Description SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose. Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached. Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters: CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control. standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive)pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins
Measure Participants 83 90
Count of Participants [Participants]
19
22.9%
40
44.4%
2. Primary Outcome
Title In-hospital Death Within 28 Days
Description We reported below the number of participants who died within 28 days, during the hospital stay.
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Arm/Group Description SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose. Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached. Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters: CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control. standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive)pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins
Measure Participants 83 90
Count of Participants [Participants]
6
7.2%
21
23.3%
3. Primary Outcome
Title Admission to Intensive Care Unit (ICU)
Description We reported below the number of participants admitted to ICU within 28 days.
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Arm/Group Description SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose. Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached. Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters: CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control. standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive)pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins
Measure Participants 83 90
Count of Participants [Participants]
15
18.1%
27
30%
4. Primary Outcome
Title Endotracheal Intubation (Invasive Mechanical Ventilation)
Description We reported below the number of participants who needed endotracheal intubation during ICU admission
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Arm/Group Description SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose. Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached. Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters: CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control. standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive)pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins
Measure Participants 83 90
Count of Participants [Participants]
15
18.1%
26
28.9%
5. Secondary Outcome
Title Change in C-reactive Protein (CRP)
Description Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement.
Time Frame 7 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Arm/Group Description SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose. Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached. Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters: CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control. standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive)pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins
Measure Participants 83 90
Mean (Standard Deviation) [mg/L]
-82.08
(28.24)
-34.34
(66.64)
6. Secondary Outcome
Title Number of Days Free From Mechanical Ventilation
Description number of days free from mechanical ventilation (both invasive and non-invasive) by day 28
Time Frame 28 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Arm/Group Description SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose. Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached. Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters: CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control. standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive)pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins
Measure Participants 83 90
Mean (Standard Deviation) [days]
19.11
(8.73)
14.34
(11.65)

Adverse Events

Time Frame 28 days
Adverse Event Reporting Description
Arm/Group Title Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Arm/Group Description SARS-CoV-2 positive patients with severe acute respiratory syndrome consecutively treated with methylprednisolone (MP) at prolonged dose. Inclusion criteria checked, the patient undergo 80mg iv bolus of MP followed by infusion (10cc/h) of MP in 240cc 0.9% saline every day until PaO2/FiO2 increase over 350 and/or CRP decrease below 20mg/L, then MP is administered PO tapering slowly until normal CRP values (+20%) are reached. Methylprednisolone: after initial 80mg iv bolus followed by 80mg in 240cc 0.9% saline administered iv at 10cc/h speed for at least 7 day or more. Duration of Methylprednisolone treatment depends from CRP and P/F values already described in arm/group description standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive) pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins Concurrent patients with the same inclusion/section exclusion criteria never treated with steroids, strictly matched according to gender and age (+/-10 years) and other three parameters: CRP, SOFA score, PaO2:FiO2 -> each parameter must be <20% difference between case and control. standard care: usual standard of care: respiratory support empiric antibiotic therapy mechanical ventilation (invasive or noninvasive)pronation when possible other treatment which can be used are: antivirals, chloroquine, vitamins
All Cause Mortality
Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 9/83 (10.8%) 24/90 (26.7%)
Serious Adverse Events
Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 6/83 (7.2%) 9/90 (10%)
Cardiac disorders
Acute myocardial infarction 1/83 (1.2%) 1 1/90 (1.1%) 1
General disorders
Shock 0/83 (0%) 0 1/90 (1.1%) 1
Nervous system disorders
Stroke 0/83 (0%) 0 1/90 (1.1%) 1
Renal and urinary disorders
Acute renal failure 2/83 (2.4%) 2 4/90 (4.4%) 4
Vascular disorders
Disseminated intravascular coagulation 2/83 (2.4%) 2 1/90 (1.1%) 1
Pulmonary embolism 1/83 (1.2%) 1 1/90 (1.1%) 1
Other (Not Including Serious) Adverse Events
Exposed to Methylprednisolone Non-exposed to Methylprednisolone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 23/83 (27.7%) 21/90 (23.3%)
Cardiac disorders
QT elongation 7/83 (8.4%) 7 2/90 (2.2%) 2
Endocrine disorders
Hyperglycemia 8/83 (9.6%) 8 0/90 (0%) 0
Gastrointestinal disorders
Diarrhea 1/83 (1.2%) 1 6/90 (6.7%) 6
General disorders
Bacterial superinfection 1/83 (1.2%) 1 1/90 (1.1%) 1
Hypokalemia 6/83 (7.2%) 6 13/90 (14.4%) 13
Hepatobiliary disorders
Transaminase elevation 2/83 (2.4%) 2 2/90 (2.2%) 2
Psychiatric disorders
Agitation 9/83 (10.8%) 9 2/90 (2.2%) 2
Respiratory, thoracic and mediastinal disorders
Pneumothorax 1/83 (1.2%) 1 0/90 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Prof. Marco Confalonieri
Organization University of Trieste
Phone +393356895168 ext 4667
Email mconfalonieri@units.it
Responsible Party:
marco confalonieri, Head of Pulmonology and Critical care Dept., University of Trieste
ClinicalTrials.gov Identifier:
NCT04323592
Other Study ID Numbers:
  • MP-19 023_2020
First Posted:
Mar 26, 2020
Last Update Posted:
Jun 24, 2020
Last Verified:
Jun 1, 2020