Adalimumab for Coronavirus in Community Care

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 750

Inclusion Criteria

Participants are eligible for the trial if all of the following are true:
•Aged at = 18 years
•Confirmed SARS-CoV-2 infection based on a validated test
•CRP >50 mg/L or Lymphopaenia (<1.5 x 109/L) or Neutrophilia (>7.5 x 109/L)
•Oxygen saturation >93% on air (pulse oximeter)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 650

Exclusion Criteria

The participant may not enter the trial if ANY of the following apply:
•Subject is considered to be in their last few weeks of life prior to this acute illness
•Clinical frailty score of 8 or 9 prior to this acute illness
oNote that acute delirium is not an exclusion
•History of haematopoietic stem cell transplant or solid organ transplant
•Chronic Obstructive Pulmonary Disease on long term oxygen therapy
oSubjects with FEV1 known to be <50% will also be excluded
•Concomitant use of DMARDs (including csDMARDs, tsDMARDs and bDMARDs) or other immuno-suppressants
•Previous malignancy and lymphoproliferative disorders (within the last 5 years) with the exception of stable prostate cancer and basal cell carcinoma
•Current participation in another therapeutic interventional clinical study for COVID-19
•De-myelinating disease
•Known to be co-infected with Hepatitis B Virus, HIV
•Severe hepatic impairment
•Acute Kidney Injury Stage 3 (NHS England Acute Kidney Injury algorithm)
•Patients with tuberculosis or other severe infections such as (non-COVID-19) sepsis, abscesses, fungal superinfection and opportunistic infections requiring treatment.
•Moderate or severe heart failure (NYHA class III/IV)
•Treatment with anti-TNF drug in past 180 days (9 half lives of the drug)
•Pregnancy
•Lactating females
•Women of child bearing 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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