effect of anakinra in treatment of COVID-19

Phase 3

Not yet recruiting

• Conditions: COVID-19.; U07.1; COVID-19, virus identified

• Registration Number: IRCT20120703010178N20
• Lead Sponsor: Persisgen Par Pharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Age of 18 years or more
Elevated C-reactive protein levels
Fever or cough or dyspnea
SpO2 of 93% or less
Confirmed SARS-CoV-2 infection by rt-PCR or radiology
PaO2/FiO2 of 300 or less
Ability to understand and desire to sign a form of informed consent to participate in the study

Exclusion Criteria

Positive PPD test
Active Hepatitis B or C infection, Positive HBV antigen or HCV antigen or HIV infection
Thrombocytopenia ( platelet count of 150000 per micL)
Leukopenia ( white blood cells of 3.6*10^9)
Anemia (hemoglobin of 7.5 g/dL)
Elevated liver transaminases of 2 fold or more
Active infection based on cultures (not received intravenous antibiotics in previous 8 weeks or oral antibiotics in previous 2 weeks)
history of malignancy in previous 5 years based on pathology and radiological data
history of anakinra, canakinumab or any interleukin-1 inhibitors administration
History of receiving of attenuated vaccine in last 2 weeks or during the study
hypersensitivity to any component of the medication

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
o need for hospitalization. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.;Hospitalization without need for oxygenation therapy. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.;Hospitalization with oxygen therapy. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.;Hospitalization with receiving non-invasive ventilation or high flow oxygen cannula. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.;Hospitalization with receiving mechanical ventilation or extra-corporeal membrane oxygenation. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.;Death. Timepoint: During first 14 days or hospitalization period. Method of measurement: Based on clinical status.