CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Tocilizumab Prefilled SyringeWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


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

Correlated MeSH Terms (3)


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

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Single-center, Randomized, Open-label Study in Patients With COVID-19 and Respiratory Distress Not Requiring Mechanical Ventilation, to Compare Standard-of-care With Anakinra and Tocilizumab Treatment The Immunomodulation-CoV Assessment (ImmCoVA) Study

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

NCT04412291 Covid-19 Drug: Anakinra Prefilled Syringe Drug: Tocilizumab Prefilled Syringe Drug: Standard-of-care treatment

Primary Outcomes

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 29

Secondary Outcomes

Measure: Mortality

Time: Up to day 29

Measure: Number of Days on mechanical ventilation

Time: Up to day 29

Measure: Number of days of supplemental oxygen use

Time: Up to day 29

Measure: Number of patients requiring initiation of mechanical ventilation

Time: Up to day 29

Description: 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 29

Description: 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 29

Description: 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 15

Description: 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 29

Measure: Mean change in Sequential organ failure assessment score (SOFA)

Time: Up to day 29

Description: 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 29

Description: 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 29

Description: 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 29

Measure: Mean change in NEWS2 scoring system (National Early Warning Score)

Time: Up to day 29

Description: 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

Measure: Number of days of resting respiratory rate >24 breaths/min

Time: Up to day 29

Measure: Time to saturation ≥94% on room air

Time: Up to day 29

Measure: Incidence of serious adverse events

Time: Up to day 60

Measure: Incidence of severe or life-threatening bacterial, invasive fungal, or opportunistic infection

Time: Up to day 29

Measure: Incidence of severe or life-threatening bacterial, invasive fungal, or opportunistic infection in patients with grade 4 neutropenia

Time: Up to day 60

Measure: Incidence of hypersensitivity reactions

Time: Up to day 29

Measure: Incidence of infusion reactions

Time: Up to day 29

Measure: Number of ventilator free days in the first 28 days

Time: Baseline to day 29

Measure: Number of patients requiring non-invasive ventilation

Time: Up to day 29

Measure: Number of patients requiring the use of high flow nasal cannula

Time: Up to day 29

Measure: Number of patients requiring Extracorporeal membrane oxygenation (ECMO)

Time: Up to day 29

Measure: Number of patients that have been admitted into an intensive care unit (ICU)

Time: Up to day 29

Measure: Number of days of hospitalization in survivors

Time: Up to day 29

Measure: Number of deaths due to any cause

Time: Up to day 60


No related HPO nodes (Using clinical trials)