Safety and efficacy of anakinra treatment for patients with persistent respiratory symptoms post acute covid and immune system activation: the PRECISION double-blind, randomized clinical trial

Conditions

Post-Acute COVID Syndrome (PACS)

Brief summary

A positive score is achieved when both of the Conditions A and B are completed. The conditions A and B are explicitly explained in the study protocol.

Detailed description

The frequency of the Score of PACS progression reversal between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment (+4 weeks of placebo), Changes in cytokine production capacity of stimulated PBMCs at week 4 between the two arms of treatment, Change of each component of the score for the primary outcome at week 4 between the two arms of treatment, At least 10% decrease of the pulmonary artery pressure at week 4 between the two arms of treatment, At least 10% increase of LV ejection fraction (if abnormal at baseline) at week 4 between the two arms of treatment, The number of meters walked during the 6-min walk test between the two arms of treatment at week 4, The number of meters walked during the 6-min walk test between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment, Number of criteria of the Condition A met, Safety of anakinra

Related papers

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Interventions

DRUGKineret 100 mg/0.67 ml solution for injection in pre-filled syringe.

DRUGKINERET Placebo sol inj 0 mg 0

DRUG67 ml syringe for clinical packaging

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
A positive score is achieved when both of the Conditions A and B are completed. The conditions A and B are explicitly explained in the study protocol.	—

Secondary

Measure	Time frame
The frequency of the Score of PACS progression reversal between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment (+4 weeks of placebo), Changes in cytokine production capacity of stimulated PBMCs at week 4 between the two arms of treatment, Change of each component of the score for the primary outcome at week 4 between the two arms of treatment, At least 10% decrease of the pulmonary artery pressure at week 4 between the two arms of treatment, At least 10% increase of LV ejection fraction (if abnormal at baseline) at week 4 between the two arms of treatment, The number of meters walked during the 6-min walk test between the two arms of treatment at week 4, The number of meters walked during the 6-min walk test between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment, Number of criteria of the Condition A met, Safety of anakinra	—

Measure

Time frame

The frequency of the Score of PACS progression reversal between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment (+4 weeks of placebo), Changes in cytokine production capacity of stimulated PBMCs at week 4 between the two arms of treatment, Change of each component of the score for the primary outcome at week 4 between the two arms of treatment, At least 10% decrease of the pulmonary artery pressure at week 4 between the two arms of treatment, At least 10% increase of LV ejection fraction (if abnormal at baseline) at week 4 between the two arms of treatment, The number of meters walked during the 6-min walk test between the two arms of treatment at week 4, The number of meters walked during the 6-min walk test between patients receiving 8 weeks anakinra treatment compared to patients receiving 4 weeks anakinra treatment, Number of criteria of the Condition A met, Safety of anakinra

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Countries

Germany, Greece, Italy, Spain

Outcome results

None listed