Name (Synonyms) | Correlation | |
---|---|---|
drug72 | Anti-SARS-CoV2 Serology Wiki | 0.71 |
drug161 | Biological: COVID-19 convalescent plasma Wiki | 0.71 |
drug923 | Questionnaire Wiki | 0.24 |
Name (Synonyms) | Correlation | |
---|---|---|
D055371 | Acute Lung Injury NIH | 0.18 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.18 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.16 |
D011024 | Pneumonia, Viral NIH | 0.10 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
D018352 | Coronavirus Infections NIH | 0.03 |
Name (Synonyms) | Correlation |
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There are 2 clinical trials
The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Most cases are mild or asymptomatic. However, around 5% of all patients develop Acute Respiratory Distress Syndrome (ARDS), which is the leading mortality cause in these patients. Corticosteroids have been tested in deferent scenarios of ARDS, including viral pneumonia, and the early use of dexamethasone is safe and appears to reduce the duration of mechanical ventilation in ARDS patients. Nevertheless, no large, randomized, controlled trial was performed evaluating the role of corticosteroids in patients with ARDS due SARS-CoV2 virus. Therefore, the present study will evaluate the effectiveness of dexamethasone compared to control (no corticosteroids) in patients with moderate and severe ARDS due to SARS-CoV2 virus.
Description: Ventilator-free days, defined as alive and free from mechanical ventilation, at 28 days after randomization.
Measure: Ventilator-free days Time: 28 days after randomizationDescription: Evaluation of the clinical status of patients on the 15th day after randomization defined by the 6-point Ordinal Scale, this scale ranges from 1 (Not hospitalized) to 6 (Death) with higher scores meaning worse outcomes.
Measure: Evaluation of the clinical status Time: 15 days after randomizationDescription: All-cause mortality rates at 28 days after randomization.
Measure: All-cause mortality Time: 28 days after randomizationDescription: Number of days of mechanical ventilation from randomization to day 28.
Measure: Mechanical ventilation duration Time: 28 days after randomizationDescription: Sequential Organ Failure Assessment (SOFA) Score 48 hours, 72 hours and 7 days after randomization
Measure: Sequential Organ Failure Assessment (SOFA) Score Time: Score at 48 hours, 72 hours and 7 days after randomizationDescription: Intensive Care Unit free days, defined as alive and discharged from the intensive care unit, at 28 days after randomization.
Measure: Intensive Care Unit free days Time: 28 days after randomizationThere is compelling data indicating that there is an excessive inflammatory response in some patients with COVID-19 leading them to develop ARDS that can be severe with a very poor prognosis. Many of these patients require very long mechanical ventilation times to survive, which have led to the collapse of the health system in some regions of the world. The current evidence for the treatment of these severe forms is inconsistent and most scientific societies and governmental or international organizations recommend evaluating treatments with randomized clinical trials. Corticosteroids, being non-specific anti-inflammatory drugs, could shorten the duration of respiratory failure and improve the prognosis. Due to the lack of solid data available regarding this serious disease, our objective is to randomly evaluate the efficacy and safety of the use of dexamethasone, a parenteral corticosteroid approved in Argentina, in patients with ARDS with confirmed respiratory infection due to SARS-CoV-2 (COVID-19).
Description: Days without ventilator support in the first 28 days of hospitalization
Measure: Ventilator-free days at 28 days Time: 28 days after starting mechanical ventilationDescription: Dead rate within 28 days of ICU admission
Measure: 28-days mortality Time: 28 days after ICU admissionDescription: Frequency of ventilator associated pneumonia, blood stream infection or candidemia in the first 28 days
Measure: Frequency of nosocomila infections Time: 28 days after ICU admissionDescription: Frequency of positive PCR on nasopharingeal swab
Measure: Viral shedding Time: 10 days after randomizationDescription: Change from baseline CPR
Measure: Serum C-reactive Protein variation Time: 10 days after randomizationDescription: Variation in SOFA over the first 10 days after randomization
Measure: SOFA variation Time: 10 days after randomizationDescription: Cumulative hours spent on prone position
Measure: Use of prone position Time: 10 days after randomizationDescription: Frequency of delirium at ICU discharge
Measure: Delirium Time: 28 days after ICU admissionDescription: mMRC score at ICU discharge
Measure: Muscle weakness Time: 28 days after ICU admission