MP-C19: Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome
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:
-
Exposed to low prolonged doses of Methylprednisolone
-
Not exposed to corticosteroids (standard of care alone)
The two group will be weighted by means of a propensity score according to:
-
Sex
-
Age
-
C-reactive protein (CRP) at baseline
-
Sequential Organ Failure Assessment (SOFA) score at baseline
-
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.
-
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.
-
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
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
- 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.
- In-hospital Death Within 28 Days [28 days]
We reported below the number of participants who died within 28 days, during the hospital stay.
- Admission to Intensive Care Unit (ICU) [28 days]
We reported below the number of participants admitted to ICU within 28 days.
- Endotracheal Intubation (Invasive Mechanical Ventilation) [28 days]
We reported below the number of participants who needed endotracheal intubation during ICU admission
Secondary Outcome Measures
- 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.
- 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
Inclusion Criteria:
-
SARS-CoV-2 positive
-
Age >17 years and < 80 years
-
P/F < 250 mmHg
-
Bilateral pneumonia (infiltrates/interstitial)
-
CRP >10mg/dL (or >100mg/L)
-
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
- MP-19 023_2020
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
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%
|
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%
|
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%
|
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%
|
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)
|
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
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 |
mconfalonieri@units.it |
- MP-19 023_2020