Name (Synonyms) | Correlation | |
---|---|---|
drug163 | Anakinra Prefilled Syringe Wiki | 1.00 |
drug17 | 1: ILT101 Wiki | 1.00 |
drug29 | 2: Placebo Comparator Wiki | 1.00 |
drug2352 | Standard-of-care treatment Wiki | 1.00 |
Name (Synonyms) | Correlation | |
---|---|---|
D055371 | Acute Lung Injury NIH | 0.10 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.10 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.09 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
The study is designed as a randomized, controlled, single-center open-label trial to compare standard-of-care (SOC) treatment with SOC + anakinra or SOC + tocilizumab treatment in hospitalized adult subjects who are diagnosed with severe COVID 19. Arm A: Standard-of-care Treatment (SOC) Arm B: Anakinra + SOC Arm C: Tocilizumab + SOC. All subjects will be treated with standard-of-care treatment and broad spectrum antibiotics initiated before or latest 24 hours after initiation of treatment with study drug. The primary follow up period of the study is 29 days
Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale:1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 1; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities. 1 LMWH-injections (Fragmin, Innohep) do not count as medical care
Measure: Time to recovery Time: Day 1 through Day 29Description: Definition of improvement in oxygenation: Increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
Measure: Time to improvement in oxygenation for at least 48 hours Time: Up to day 29Description: 8-point Ordinal Scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow nasal cannula; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized
Measure: Mean change in the 8-point ordinal scale Time: Up to day 29Description: 8-point Ordinal Scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow nasal cannula; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized
Measure: Proportion of patients on level e-h on the 8-point ordinal scale at day 15 Time: Day 15Description: 8-point Ordinal Scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow nasal cannula; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized
Measure: Time to improvement in one category from admission using the 8-point ordinal scale Time: Up to day 29Description: Defined as ≤36.6°C (axilla), ≤37.2°C (oral) or ≤37.8°C (rectal or tympanic)
Measure: Time to resolution of fever for at least 48 hours by clinical severity Time: Up to day 29Description: NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C)
Measure: Time to change in National Early Warning Score 2 (NEWS2) scoring system Time: Up to day 29Description: NEWS2 consists of: Physiological Parameters: Respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), Use of Air or oxygen, Systolic blood pressure (mmHg), Pulse (per minute), Consciousness, Temperature (°C)
Measure: Time to score of <2 maintained for 24 hours in NEWS2 scoring system (National Early Warning Score) Time: Up to day 29Description: Fever defined as >36.6°C (axilla), >37.2°C (oral) or >37.8°C (rectal or tympanic)
Measure: Number of days with fever Time: Up to day 29