Severe COVID-19 (SARS-CoV-2 infection) Respiratory COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Eligible patients providing written informed consent will be administered anakinra (in addition to standard treatment as defined by the hospital protocols) via a subcutaneous route over 10 days as fol
Sponsors
Sultan Qaboos University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >18 years 2. Admitted to the participating hospital with COVID-19 and any of the following: 2.1. Severe pneumonia defined as pneumonia and respiratory rate >30 breaths/min; or SpO2 <90% in room air or 93% or less under oxygen 6 l/min or more in addition to signs indicative of worsening respiratory function 2.2. Acute respiratory distress syndrome (ARDS) defined as pneumonia and bilateral opacities (on chest x-ray) and respiratory failure with PaO2/FiO2 =300 mmHg
Exclusion criteria
Exclusion criteria: 1. Known allergy to anakinra 2. Pregnant or breast-feeding women 3. Active or untreated TB 4. Apparent risk for gastrointestinal perforation (defined as recent [within 3 months] abdominal surgery, active inflammatory bowel disease, or active endoscopy-proven peptic ulcer disease) 5. Active cancer 6. Active bacterial or fungal infection 7. Chronic active liver disease 8. Absolute neutrophil count (ANC <1,500) or platelet count <50,000 /µl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Need for invasive mechanical ventilation (IMV) or admission to the intensive care unit (ICU) is assessed from patient notes/records between baseline and 14 days 2. In-hospital mortality is assessed from patient notes/records between baseline and death or discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in the mean oxygen therapy requirements at baseline, 4 and 14 days 2. Change in the inflammatory biomarkers of disease severity (D-dimer, absolute lymphocyte count, serum ferritin, lactate dehydrogenase, c-reactive protein, and interleukin [IL-6] levels) measured using blood serum samples at baseline, 4 and 14 days | — |
Countries
Oman
Contacts
Public ContactAbdullah Balkhair
Outcome results
None listed