COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Intervention: Adalimumab
Regimen 1. A loading dose of 80 mg adalimumab given as two injections of 40 mg at separate sites in the thigh or abdomen. Subjects with persistent symptoms an
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Confirmed SARS-CoV-2 infection based on a validated test 3. CRP >50 mg/l or lymphopaenia (7.5 x 10(9)/l) 4. Oxygen saturation >93% on air (pulse oximeter) Note: Point of care testing and the associated results are acceptable for assessment of eligibility
Exclusion criteria
Exclusion criteria: 1. Subject is considered to be in their last few weeks of life prior to this acute illness 2. Clinical frailty score of 8 or 9 prior to this acute illness 3. History of haematopoietic stem cell transplant or solid organ transplant 4. Chronic obstructive pulmonary disease (COPD) on long term oxygen therapy (Subjects with FEV1 known to be <50% will also be excluded) 5. Concomitant use of DMARDs (including csDMARDs, tsDMARDs and bDMARDs) or other immuno-suppressants 6. Previous malignancy and lymphoproliferative disorders (within the last 5 years) with the exception of stable prostate cancer and basal cell carcinoma 7. Current participation in another therapeutic interventional clinical study for COVID-19 8. De-myelinating disease 9. Known to be co-infected with Hepatitis B Virus, HIV 10. Severe hepatic impairment 11. Acute Kidney Injury Stage 3 (NHS England Acute Kidney Injury algorithm) 12. Patients with tuberculosis or other severe infections such as (non-COVID-19) sepsis, abscesses, fungal superinfection and opportunistic infections requiring treatment. 13. Moderate or severe heart failure (NYHA class III/IV) 14. Treatment with anti-TNF drug in past 180 days (9 half lives of the drug) 15. Pregnancy 16. Lactating females 17. Women of childbearing potential who are unwilling to use effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the study and 5 months afterwards
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of progression to severe disease as defined by severe illness, or critical illness, or death from any cause in community care patients with COVID-19 at 28 days from randomisation measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Recorded out to 120 days post randomisation using patient records: 1. Serious Adverse Events 2. Adverse events (frequency and severity) 3. Clinical status (9 point ordinal scale) 4. COVID symptom score measured using COVID-19 Core Outcome Set scales 5. Admission to secondary care hospital, ICU or HDU 6. Discharge from secondary care hospital 7. Secondary care hospital assessment without admission 8. Degree of dependency measured by the Barthel scale 9. Frailty measured using Clinical Frailty Scale 10. Incidence and duration of delirium (4AT score) 11. Incidence of venous thromboembolism and acute kidney injury 12. Frequency of prescription of antibiotics | — |
Countries
England, United Kingdom
Contacts
Public ContactDuncan Richards
Outcome results
None listed