Corona Virus Infection, Covid19, Cytokine Release Syndrome, Pneumonia, Viral Infection
Conditions
Brief summary
Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.
Interventions
DRUGAnakinra
Patient will receive Anakinra 100 mg SC injection every 12 hours for 3 days, then 100 mg once daily from day 4 to day 7 plus Standard of Care
OTHERStandard of Care
Patients will receive the Standard of Care therapy as per the local treatment protocol
Sponsors
Hamad Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized adult (age ≥ 18yrs) * Confirmed COVID-19 diagnosis * Presence of respiratory distress in addition to signs of cytokine release syndrome * Radiological evidence of pneumonia * Signed informed consent
Exclusion criteria
* Known allergic reactions to the study medication or any component of the product. * Active bacterial, viral, TB, fungal infectious diseases * Received immunosuppressant or immunomodulatory in the past 30 days * Neutrophil count \< 500 cells/microliter * Platelets \< 50,000/microliter * Pregnant or breastfeeding females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success at day 14 | Day 14 | Defined as WHO Clinical Progression score of ≤3 \[Ambulatory mild disease: symptomatic; assistance needed\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WHO Clinical Progression Score | Day 7 | Change in WHO Clinical Progression Score between day 1 and day 7 \[WHO Clinical Progression score: 0 (Uninfected) - 10 (Dead)\] |
| Time to ICU admission | Day 28 | Time to ICU admission up to 28 days |
| Incidence of Adverse Events | Day 28 | Incidence of adverse events up to 28 days |
| Length of hospital stay | Day 28 | Length of hospital stay up to 28 days |
| All-cause Mortality | Day 28 | All-cause mortality rate at hospital discharge or at 28 days, whichever is first |
Countries
Qatar
Outcome results
None listed