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MethylprednisoloneWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (20)


Name (Synonyms) Correlation
drug1131 Hydroxychloroquine, Doxycycline Wiki 0.30
drug2438 Tacrolimus Wiki 0.30
drug782 Docetaxel Wiki 0.30
drug1223 Interferon-Alpha2B Wiki 0.30
drug1130 Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki 0.30
drug1127 Hydroxychloroquine, Azithromycin Wiki 0.30
drug330 Berzosertib Wiki 0.30
drug656 Convalescent Serum Wiki 0.30
drug1129 Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki 0.30
drug1319 Laboratory Biomarker Analysis Wiki 0.30
drug1128 Hydroxychloroquine, Clindamycin Wiki 0.30
drug522 Carboplatin Wiki 0.21
drug2256 Siltuximab Wiki 0.21
drug3005 standard care Wiki 0.17
drug2612 Usual Care Wiki 0.13
drug2527 Tocilizumab Wiki 0.11
drug1598 Nitazoxanide Wiki 0.11
drug1374 Losartan Wiki 0.11
drug2067 Remdesivir Wiki 0.08
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (11)


Name (Synonyms) Correlation
D011471 Prostatic Neoplasms NIH 0.17
D002277 Carcinoma NIH 0.13
D011014 Pneumonia NIH 0.13
D018450 Disease Progression NIH 0.08
D014947 Wounds and Injuries NIH 0.07
D055370 Lung Injury NIH 0.06
D011024 Pneumonia, Viral NIH 0.04
D013577 Syndrome NIH 0.03
D012128 Respiratory Distress Syndrome, Adult NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0012125 Prostate cancer HPO 0.17
HP:0030731 Carcinoma HPO 0.13
HP:0002090 Pneumonia HPO 0.13

There are 11 clinical trials

Clinical Trials


1 SMART Trial: Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia

In community acquired pneumonia, corticosteroids have been shown to have potential benefit. However, the limited and variable use of adjunctive corticosteroids in critically ill patients is largely due to an inability to identify patients that will benefit from the use of anti-inflammatory medications. This study compares usual care to a novel biomarker-tailored steroid dosing algorithm for patients with community acquired pneumonia. In April 2020, in response to the SARS CoV-2 pandemic, we added a COVID-19 arm to this study. The study will evaluate the role of biomarker-titrated adjuvant corticosteroid administration compared to usual care in patients admitted to hospital with SARS CoV-2 (COVID-19) infection and acute respiratory failure.

NCT03852537 Pneumonia Drug: Methylprednisolone Other: Usual Care
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: A percentage of eligible patients adhered to the timely initiation (within 12 hours of emergency room admission) and daily corticosteroid treatment according to ESICM/SCCM clinical practice guideline (control group) or biomarker concordance (intervention group)

Measure: Feasibility of the timely initiation of corticosteroids and implementation of biomarker-titrated corticosteroid dosing: percentage of eligible patients adhered to the timely initiation

Time: Within 30 days of enrollment in study.

Secondary Outcomes

Description: Death from any cause

Measure: Mortality

Time: Within 30 days and 90 days of study enrollment

Description: Progression of disease is defined by the need for high flow nasal cannula oxygen, noninvasive or invasive ventilation. Given the proliferation of high flow nasal cannula oxygen use in lieu of mechanical ventilation, instead of ventilator-free days the investigators opt for using advanced respiratory support free days where "advanced respiratory support" includes both invasive and noninvasive mechanical ventilation and the high flow nasal cannula oxygen.

Measure: Progression of disease

Time: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Description: Measured by respiratory component of SOFA at time of ICU admission, after 24 hours, after 48 hours and after 72 hours and by the organ failure free days. In the absence of daily arterial blood gas analysis, PaO2/FiO2 ratio will be replaced by SpO2/FiO2 ratio

Measure: Evolution of respiratory failure

Time: Within 72 hours of enrollment in study.

Description: Assessed by renal component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no renal failure and 4 indicating severe renal failure).

Measure: Evolution of kidney failure

Time: Within 72 hours of enrollment in study.

Description: Assessed by cardiac component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no cardiovascular failure and 4 indicating severe cardiovascular failure).

Measure: Evolution of shock

Time: Within 72 hours of enrollment in study.

Description: In hospital and in ICU

Measure: Length of stay

Time: From time of study enrollment up to discharge from hospital, to a maximum of 1 year.

Description: Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration.

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Hyperglycemia

Time: Up to day +5 following study enrollment.

Description: Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium.

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Delirium

Time: Up to day +5 following study enrollment.

Description: Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued.

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Secondary Infection

Time: Up to day +14 following study enrollment.

2 An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia

At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.

NCT04263402 2019-nCoV Severe Pneumonia Drug: Methylprednisolone Drug: Methylprednisolone
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2>93% or PaO2/FiO2 >300mmHg.

Measure: Rate of disease remission

Time: day 7

Description: the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.

Measure: Rate and time of entering the critical stage

Time: day 7

Secondary Outcomes

Description: Rate of patients without fever at day 7

Measure: Rate of normal tempreture

Time: day 7

Description: Rate of patients with respiratory symptom remission at day 7

Measure: Rate of respiratory symptom remission

Time: day 7

Description: Rate of patients with lung imaging recovery at day 7

Measure: Rate of lung imaging recovery

Time: day 7

Description: Rate of patients with laboratory indicator recovery at day 7

Measure: Rate of laboratory indicator recovery

Time: day 7

Description: Rate of patients withundetectable viral RNA at day 7

Measure: Rate of undetectable viral RNA

Time: day 7

3 An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia

At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.

NCT04263402 2019-nCoV Severe Pneumonia Drug: Methylprednisolone Drug: Methylprednisolone
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2>93% or PaO2/FiO2 >300mmHg.

Measure: Rate of disease remission

Time: day 7

Description: the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.

Measure: Rate and time of entering the critical stage

Time: day 7

Secondary Outcomes

Description: Rate of patients without fever at day 7

Measure: Rate of normal tempreture

Time: day 7

Description: Rate of patients with respiratory symptom remission at day 7

Measure: Rate of respiratory symptom remission

Time: day 7

Description: Rate of patients with lung imaging recovery at day 7

Measure: Rate of lung imaging recovery

Time: day 7

Description: Rate of patients with laboratory indicator recovery at day 7

Measure: Rate of laboratory indicator recovery

Time: day 7

Description: Rate of patients withundetectable viral RNA at day 7

Measure: Rate of undetectable viral RNA

Time: day 7

4 Efficacy and Safety of Corticosteroids in COVID-19: A Prospective Randomized Controlled Trails

There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.

NCT04273321 COVID-19 Novel Coronavirus Pneumonia Drug: Methylprednisolone
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.

Measure: the incidence of treatment failure in 14 days

Time: 14 days

Secondary Outcomes

Description: The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed.

Measure: clinical cure incidence in 14 days

Time: 14 days

Description: the duration from admission to virus negative

Measure: the duration of virus change to negative

Time: 30 days

Description: the patient die in 30 days

Measure: mortality at day 30

Time: 30 days

Description: the patients transform to ICU because of clinical deteriorate in 30 days

Measure: ICU admission rate in 30 days

Time: 30 days

5 Prolonged Low Doses of Methylprednisolone for Patients With COVID-19 Severe Acute Respiratory Syndrome

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).

NCT04323592 Severe Acute Respiratory Syndrome (SARS) Pneumonia Coronavirus Infections ARDS, Human Drug: Methylprednisolone Other: standard care
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia Respiratory Distress Syndrome, Adult Syndrome
HPO:Pneumonia

Primary Outcomes

Description: We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation.

Measure: Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28

Time: 28 days

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

Measure: In-hospital Death Within 28 Days

Time: 28 days

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

Measure: Admission to Intensive Care Unit (ICU)

Time: 28 days

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

Measure: Endotracheal Intubation (Invasive Mechanical Ventilation)

Time: 28 days

Secondary Outcomes

Description: Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement.

Measure: Change in C-reactive Protein (CRP)

Time: 7 days

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

Measure: Number of Days Free From Mechanical Ventilation

Time: 28 days

6 Phase 2, Randomized, Open-label Study to Compare Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID19 Pneumonia

In our center up to 25% of the hospitalized patients with COVID-19 progress and need an intensive care unit. It is urgent to find measures that can avoid this progression to severe stages of the disease. We hypothesize that the use of anti-inflammatory drugs used at the time they start hyperinflammation episodes could improve symptoms and prognosis of patients and prevent their progression sufficiently to avoid their need for be admitted to an Intensive Care Unit.

NCT04329650 COVID-19 Drug: Siltuximab Drug: Methylprednisolone
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Proportion of patients requiring ICU admission at any time within the study period.

Time: 29 days

Secondary Outcomes

Measure: Days of stay in the ICU during the study period.

Time: 29 days

Measure: Days until resolution of fever defined as body temperature (axillary ≤ 36.6 ° C, oral ≤ 37.2 ° C, or rectal or tympanic ≤ 37.8 ° C) for at least 48 hours, without administration of antipyretics or until hospital discharge.

Time: 29 days

Measure: Proportion of patients with a worsening requirement of supplemental oxygen at 29 days. days.

Time: 29 days

Measure: Days with hypoxemia (SpO2 <93% in ambient air or requiring oxygen supplemental or mechanical ventilation support) at 29 days.

Time: 29 days

Measure: Proportion of patients using mechanical ventilation at 29 days.

Time: 29 days

Measure: Days with use of mechanical ventilation at 29 days.

Time: 29 days

Measure: Days until the start of use of mechanical ventilation, non-invasive ventilation or use of high flow nasal cannula (if the patient have not previously required these interventions at the inclusion of the study) at 29 days.

Time: 29 days

Measure: Days of hospitalization among survivors at 29 days.

Time: 29 days

Measure: Mortality rate from any cause at 29 days.

Time: 29 days

Measure: Proportion of patients with serious adverse events at 29 days.

Time: 29 days

Measure: Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic with grade 4 neutropenia (count neutrophil absolute <500 / mm3) at 29 days.

Time: 29 days

Measure: Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic at 29 days.

Time: 29 days

Measure: Proportion of patients with grade 2 or higher adverse reactions related to the infusion of the sudy treatments at 29 days.

Time: 29 days

Measure: Proportion of patients with hypersensitivity reactions of grade 2 or higher related to the administration of the study treatments at 29 days.

Time: 29 days

Measure: Proportion of patients with gastrointestinal perforation at 29 days.

Time: 29 days

Measure: Proportion of patients with secondary severe infections confirmed by laboratory or worsening of existing infections at 29 days.

Time: 29 days

Measure: Changes from baseline in plasma leukocyte levels at days 1, 3, 5, 7 and 9.

Time: Days 1, 3, 5, 7 and 9

Measure: Changes from baseline in plasma hemoglobin levels at days 1, 3, 5, 7 and 9.

Time: Days 1, 3, 5, 7 and 9

Measure: Changes from baseline in plasma platelet at days 1, 3, 5, 7 and 9.

Time: Days 1, 3, 5, 7 and 9

Measure: Changes from baseline in plasma creatinine levels at days 1, 3, 5, 7 and 9.

Time: Days 1, 3, 5, 7 and 9

Measure: Changes from baseline in plasma total bilirubin levels at days 1, 3, 5, 7 and 9.

Time: Days 1, 3, 5, 7 and 9

Measure: Proportion of patients with ALT≥ 3 times ULN (for patients with initial values normal) or> 3 times ULN AND at least 2 times more than the initial value (for patients with abnormal initial values) at days 1, 3, 5, 7 and 9.

Time: Days 1, 3, 5, 7 and 9

Measure: Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9.

Time: Days 1, 3, 5, 7 and 9

Measure: Changes from baseline in chest Rx at days 1, 3 and 5.

Time: Days 1, 3 and 5

7 Open Randomized Single Centre Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With Severe Lung Injury Secondary to COVID-19

The primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury.

NCT04341038 COVID-19 Lung Injury Drug: Tacrolimus Drug: Methylprednisolone
MeSH:Lung Injury Wounds and Injuries

Primary Outcomes

Description: Assess the days until clinical stability is achieved after initiating randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury. Clinical stability is defined if all the following criteria are met for 48 consecutive hours: Body temperature ≤ 37.0ºC; PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300; Respiratory rate ≤ 24 rpm

Measure: Time to reach clinical stability

Time: 28 days

Secondary Outcomes

Description: days

Measure: Time to reach an afebrile state for 48 hours.

Time: 56 days

Description: days

Measure: Time to reach PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300

Time: 56 days

Description: days

Measure: Time to reach FR ≤ 24 rpm for 48 hours

Time: 56 days

Description: days

Measure: Time to normalization of D-dimer (<250 ug / L)

Time: 56 days

Description: days

Measure: Time until PCR normalization (<5mg / L).

Time: 56 days

Description: days

Measure: Time until normalization of ferritin (<400ug / L)

Time: 56 days

Description: viral load

Measure: Study the impact of immunosuppressive treatment on viral load using quantitative PCR

Time: 56 days

Description: days

Measure: Time until hospital discharge

Time: 56 days

Description: days

Measure: Need for ventilatory support devices

Time: 56 days

Description: days

Measure: Duration that it is necessary to maintain ventilatory support.

Time: 56 days

Description: days

Measure: COVID-19 mortality

Time: 56 days

Description: days

Measure: all-cause mortality

Time: 56 days

Description: cytokines quantification technique by Luminex

Measure: Analyze the expanded cytokine profile before the start of treatment and their evolution every 7 days after admission

Time: 56 days

Description: IDIBELL Clinical Research and Clinical Trials Unit will oversee the monitoring and pharmacovigilance

Measure: Describe the side effects and their severity attributed to tacrolimus and / or methylprednisolone.

Time: 56 days

8 An Open-label, Randomized, Cross-over Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression

This study aims to compare the efficacy and safety of Methylprednisolone versus Tocilizumab in improving clinical outcomes and reducing the need for ventilator support in COVID-19 patients with moderate COVID-19 disease at risk for complications of cytokine storm. Approximately 310 participants hospitalized with COVID-19 in UMMC, Hospital Sungai Buloh, Hospital Kuala Lumpur and Hospital Tuanku Jaafar will be enrolled into this study. Eligible participants will be selected based on a set of clinical, laboratory and radiological parameters indicative of early stages of CRS and lung function decline prior to being randomized at a ratio of 1:1 to receive either Tocilizumab or Methylprednisolone. Participants will be monitored daily for clinical and laboratory parameters, and at 48 hours, switched to the alternate study arm should they manifest signs and symptoms indicative of decompensation.

NCT04345445 COVID-19 Drug: Tocilizumab Drug: Methylprednisolone
MeSH:Disease Progression

Primary Outcomes

Measure: The proportion of patients requiring mechanical ventilation

Time: Through study completion, and average of 6 months

Measure: Mean days of ventilation

Time: Through study completion, and average of 6 months

Secondary Outcomes

Measure: The proportion of patients requiring ICU admission

Time: Through study completion, and average of 6 months

Measure: Overall 28-day survival

Time: 28 day from baseline

Measure: Change in symptom severity assessed by the World Health Organization (WHO) Coronavirus Disease 2019 (COVID19) ordinal scale measured daily up to 7 days from baseline

Time: 7 days from baseline

Measure: Duration of hospital and ICU stay

Time: Through study completion, and average of 6 months

9 The Fleming [FMTVDM] Directed CoVid-19 Treatment Protocol

Diagnostic determination of disease and treatment responses has been limited to qualitative imaging, measurement of serum markers of disease, and sampling of tissue. In each of these instances, there is a built in error either due to sensitivity and specificity issues, clinician interpretation of results, or acceptance of the use of an indirect marker (blood test) of what is happening elsewhere in the body - at the tissue level. The Fleming Method for Tissue and Vascular Differentiation and Metabolism (FMTVDM) using same state single or sequential quantification comparisons [1] provides the first and only patented test (#9566037) - along with the associated submitted patent applications ruled to be covered under #9566037 - that quantitatively measures changes in tissue resulting from inter alia a disease process. This includes inter alia coronary artery disease (CAD), cancer and infectious/inflammatory processes including CoVid-19 pneumonia (CVP) resulting from the metabolic and regional blood flow differences (RBFDs) caused by these diseases. The purpose of this paper is to make clinicians and researchers aware of this proposed method for investigating the prevalence and severity of CVP - in addition to providing rapid determination of treatment response in each patient, directing treatment decisions; thereby reducing the loss of time, money, resources and patient lives.

NCT04349410 CoVid 19 Positive Drug: Hydroxychloroquine, Azithromycin Drug: Hydroxychloroquine, Doxycycline Drug: Hydroxychloroquine, Clindamycin Drug: Hydroxychloroquine, Clindamycin, Primaquine - low dose. Drug: Hydroxychloroquine, Clindamycin, Primaquine - high dose. Drug: Remdesivir Drug: Tocilizumab Drug: Methylprednisolone Drug: Interferon-Alpha2B Drug: Losartan Drug: Convalescent Serum

Primary Outcomes

Description: Measured improvement in tissue as measured using FMTVDM

Measure: Improvement in FMTVDM Measurement with nuclear imaging.

Time: 72 hours

Secondary Outcomes

Description: Extubation

Measure: Ventilator status

Time: 7 days

Description: Self explanatory

Measure: Survival status

Time: 30 days

10 Early Short Course Corticosteroids in Hospitalized Patients With COVID-19

The investigators intend to study the role of early use of methylprednisolone in the hospitalized patients with a diagnosis of COVID-19 pneumonia.

NCT04374071 COVID Pneumonia, Viral Drug: Methylprednisolone
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Number of patients transferred to ICU is each of the groups

Measure: Transfer to Intensive care unit (ICU)

Time: 14 days followup for every patient in each group

Description: Number of patients that needed mechanical ventilation in each of the groups

Measure: Need for Mechanical Ventilation

Time: 14 days followup for every patient in each group

Description: Number of patients who died in each of the groups

Measure: Mortality

Time: 14 days followup for every patient in each group

Secondary Outcomes

Description: Number of patients who developed ARDS of varying severity per Berlin classification in each of the groups

Measure: Development and Severity of ARDS

Time: 14 days followup for every patient in each group

Description: LOS in each of the groups

Measure: Length of hospital stay (LOS).

Time: 14 days followup for every patient in each group

11 Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial

Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.

NCT04438980 Covid-19 Pneumonia Drug: Methylprednisolone Other: Placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: • Death

Measure: Proportion of patients developing treatment failure

Time: At 14 days after randomization

Description: • Need for admission in an intensive care unit (ICU)

Measure: Proportion of patients developing treatment failure

Time: At 14 days after randomization

Description: • Need for mechanical ventilation

Measure: Proportion of patients developing treatment failure

Time: At 14 days after randomization

Description: • Decrease in SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, associated with radiological impairment

Measure: Proportion of patients developing treatment failure

Time: At 14 days after randomization

Secondary Outcomes

Measure: Mortality at day 28

Time: At 28 days after randomization

Measure: Proportion of patients requiring ICU admission

Time: At 28 days after randomization

Measure: Proportion of patients requiring rescue-therapy with tocilizumab

Time: At 14 days after randomization

Description: Time in days from randomization until the date of hospital discharge.

Measure: Length of hospital stay

Time: At 28 days after randomization

Description: Any undesirable experience related to the use of the studied drugs, which causes patient's death, life-threatening risk, hospitalization or extension of a previous hospitalization, disability or permanent damage, requires intervention to prevent permanent impairment or damage, or is considered medically relevant

Measure: Proportion of severe adverse events

Time: At 28 days after randomization

Measure: Proportion of bacterial, fungal or opportunistic infections

Time: At 28 days after randomization

Description: Change in plasma levels of C-reactive protein (CRP)

Measure: Evolution of inflammatory biomarkers related to COVID-19

Time: At 14 days after randomization

Description: Change in plasma levels of ferritin

Measure: Evolution of inflammatory biomarkers related to COVID-19

Time: At 14 days after randomization

Description: Change in plasma levels of interleukin-6 (IL-6)

Measure: Evolution of inflammatory biomarkers related to COVID-19

Time: At 14 days after randomization

Description: Change in plasma levels of lactate dehydrogenase (LDH)

Measure: Evolution of inflammatory biomarkers related to COVID-19

Time: At 14 days after randomization

Description: Change in plasma levels of D-dimer (DD)

Measure: Evolution of inflammatory biomarkers related to COVID-19

Time: At 14 days after randomization

Description: Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum

Measure: Proportion of SARS-CoV-2 clearance.

Time: At 7 days after randomization


Related HPO nodes (Using clinical trials)