CovidResearchTrials by Shray Alag

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Anakinra 100Mg/0.67Ml Inj SyringeWiki

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


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug2807 eculizumab Wiki 1.00

Correlated MeSH Terms (7)

Name (Synonyms) Correlation
D055370 Lung Injury NIH 0.21
D011024 Pneumonia, Viral NIH 0.13
D013577 Syndrome NIH 0.11
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.10
D012128 Respiratory Distress Syndrome, Adult NIH 0.09
D011014 Pneumonia NIH 0.06

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There is one clinical trial.

Clinical Trials

1 Subcutaneous and Intravenous IL-1Ra (Anakinra) in COVID-19 Infection - Feasibility & Pharmacokinetics/Pharmacodynamics Study

The current COVID-19 pandemic is a worldwide healthcare crisis. Of concern is the large number of patients that are/will require mechanical ventilation, and the associated strain that this will place on healthcare resources. At present, there are no specific therapeutic interventions directed at COVID-19 infection. However, observational data suggest that there is a subgroup of patients that demonstrate a hyperinflammatory response in response to COVID-19 and have a higher requirement for Critical Care and higher mortality. There is a strong case for the use of the naturally occurring anti-inflammatory cytokine interleukin-1 receptor antagonist (IL-1Ra) in these patients. Anakinra is a recombinant form of IL-1Ra that is licensed for clinical use. Success of use of anakinra in COVID-19 trials will be greatly enhanced by robust scientific evidence and established pharmacokinetics which inform the most effective dosing regimens. The latter is especially important when, as in the case of anakinra, drug supplies are limited, the drug has short half-life and clinical ease of application is critical.

NCT04462757 COVID-19 Drug: Anakinra 100Mg/0.67Ml Inj Syringe

Primary Outcomes

Description: Plasma IL-1Ra levels from Day 1 to Day 7 following administration of SC anakinra in patients with SARS-CoV-2

Measure: Plasma IL-1Ra levels

Time: 1 week

Description: Plasma IL-6 levels from Day 1 to Day 7 following administration of SC anakinra in patients with SARS-CoV-2

Measure: Plasma IL-6 levels

Time: 1 week

Secondary Outcomes

Description: Plasma markers including IL-6 from Day 1 to Day 14 in all participants

Measure: Plasma markers

Time: 2 weeks

Description: Plasma markers including CRP from Day 1 to Day 14 in all participants

Measure: Plasma markers

Time: 2 weeks

Description: Plasma markers including CXCL9 from Day 1 to Day 14 in all participants

Measure: Plasma markers

Time: 2 weeks

Description: Plasma markers including IL-1 from Day 1 to Day 14 in all participants

Measure: Plasma markers

Time: 2 weeks

Description: Plasma markers including IL-2 from Day 1 to Day 14 in all participants

Measure: Plasma markers

Time: 2 weeks

Description: Plasma markers including HMBG-1 from Day 1 to Day 14 in all participants

Measure: Plasma markers

Time: 2 weeks

Description: Plasma markers including IL-33 from Day 1 to Day 14 in all participants

Measure: Plasma markers

Time: 2 weeks

Description: Safety endpoints include: a. Severe fatal or life-threatening serious adverse reactions (duration of IMP plus 30h from last dose).

Measure: Safety Endpoints related to the Serious adverse reactions of the IMP

Time: 2 weeks

Description: Safety endpoints include: b. Anaphylactic/anaphylactoid reactions (duration of IMP plus 30h from last dose).

Measure: Safety Endpoints related to the anaphylactic reactions of the IMP

Time: 2 weeks

Description: Safety endpoints include: c. Severe neutropenia (< 1.5 x 109 /L) (duration of IMP)

Measure: Safety Endpoints related to neutropenia caused by the IMP

Time: 2 weeks

Description: Safety endpoints include: d. IMP related severe laboratory abnormalities (duration of IMP)

Measure: Safety Endpoints related to any severe laboratory abnormalities

Time: 2 weeks

Description: Feasibility endpoints include protocol deviations in terms of timing and delivery of scheduled medication.

Measure: Feasibility endpoints related to IMP and deviations

Time: 2 weeks

Description: Exploratory data on clinical efficacy as defined by: a. Time to recovery defined by hospital discharge or improvement of two points on the ordinal scale: not hospitalised; hospitalised without need for supplemental oxygen; requiring supplemental oxygen; requiring HFNC or non-invasive mechanical ventilation; requiring ECMO or mechanical intervention; dead. Improvement mechanical ventilation (from recruitment to time of ventilation)

Measure: Exploratory Data on Clinical efficacy by time to recovery

Time: 4 weeks

Description: Exploratory data on clinical efficacy as defined by: b. Ventilation free days (at 28 days)

Measure: Exploratory Data on Clinical efficacy

Time: 4 weeks

Description: Exploratory data on clinical efficacy as defined by: c. Status on the above ordinal scale (at 14 and 28 days)

Measure: Exploratory Data on Clinical efficacy of the ordinal scale

Time: 4 weeks

No related HPO nodes (Using clinical trials)