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Anakinra plus oSOCWiki

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


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug2927 oSOC Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D012818 Signs and Symptoms, Respiratory NIH 0.50

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Efficacy and Safety of ANAkinra During Adult " COVID-19 " With Aggravating Respiratory Symptoms: a Multicenter Open-label Controlled Randomized Trial

The main objective of the ANACONDA-COVID-19 trial is to assess the efficacy of Anakinra + optimized Standard of Care (oSOC) as compared to oSOC alone on the condition of patients with COVID-19 infection and worsening respiratory symptoms. Success defined as patient alive and free of invasive mechanical ventilation (IMV) and free of Extracorporeal Membrane Oxygenation (ECMO) at Day 14.

NCT04364009 COVID-19 Infection ANAKINRA Treatment Optimized Standard of Care (oSOC) Drug: Anakinra plus oSOC Drug: oSOC
MeSH:Signs and Symptoms, Respiratory

Primary Outcomes

Description: The primary endpoint is treatment success at Day 14, defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).

Measure: Treatment success

Time: After 14 days of treatment

Secondary Outcomes

Description: Defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).

Measure: Treatment success

Time: After 3 days, 10 days and 28 days of treatment

Description: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;6. Hospitalized, on invasive mechanical ventilation or ECMO;7. Death.

Measure: OMS progression scale (on a 7 point ordinal scale)

Time: After 3 days, 10 days, 14 days and 28 days of treatment

Description: Overall survival

Measure: Overall survival

Time: After 3 days, 10 days, 14 days and 28 days of treatment

Description: Time to ICU admission

Measure: Time to ICU admission

Time: Up to 28 days

Description: Time to ventilatory support : extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, non-invasive ventilation, high flow oxygen therapy)

Measure: Time to ventilatory support

Time: Up to 28 days

Description: The National Early Warning Score (NEWS) determines the degree of illness of a patient using six physiological findings and one observation. Score from 0 to 20, 0 mean a worse outcome, 20 mean a better outcome

Measure: Change in National Early Warning Score (NEW)from baseline to Day 3, Day 10, Day 14 and Day 28

Time: After 3 days, 10 days, 14 days and 28 days of treatment

Description: C-reactive proteine (mg/L)

Measure: Change in inflammatory parameter

Time: From baseline to Day 3, Day 10, Day 14 and Day 28

Description: ferritin (ng/mL)

Measure: Change in inflammatory parameter

Time: From baseline to Day 3, Day 10, Day 14 and Day 28

Description: lymphocyte count (G/L)

Measure: Change in inflammatory parameter

Time: From baseline to Day 3, Day 10, Day 14 and Day 28

Description: fibrinogen (g/l)

Measure: Change in inflammatory parameter

Time: From baseline to Day 3, Day 10, Day 14 and Day 28

Description: Hospital length of stay

Measure: Hospital length of stay

Time: Up to 28 days

Description: Need for Vasopressors (yes or no)

Measure: ICU parameter

Time: Up to 28 days

Description: Evolution of SpO2/FIO2 ratio (no unit)

Measure: ICU parameter

Time: Up to 28 days

Description: Evolution of PaO2/FiO2 ratio (no unit)

Measure: ICU parameter

Time: Up to 28 days

Description: Occurrence of serious adverse events during the study, including infection (bacterial, parasitic, mycotic and viral infection), septic shock, Ankanira hypersensitivity, hepatic damages (SGOT/SGPT, alkaline phosphatase, gammaGT) and neutropenia (Blood count).

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time: Up to 28 days

Description: The correlation between several of clinical parameters at inclusion (including level of oxygen requirement (saturation), respiratory rate (per min), temperature (°C)…), biological parameters :including, CRP (mg/L), ferritin (µg/L), LDH (UI/L), lymphocyte count (G/L), eosinophil count (G/L), Ddimers (ng/mM), platelet count (G/L), polymorphonuclear count (G/L)...with the primary end point will be explored.

Measure: Predictors of efficacy of Anakinra

Time: After 14 days of treatment


No related HPO nodes (Using clinical trials)