Study of Adalimumab or Placebo in Patients With Mild to Moderate COVID-19 (COMBAAT)

Conditions

• Mild to Moderate COVID-19

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Adalimumab — DRUG
  adalimumab (160 mg administered as 4×40 mg subcutaneous \[SC\] injections at separate sites on the thigh or abdomen)
• Placebo — DRUG
  placebo (4 SC injections of equal volume administered at separate sites on the thigh or abdomen)

Study Details

Clinical study of Humira (adalimumab) or placebo in subjects with mild-moderate COVID-19

Key Dates

Start date

Sep 30, 2021

Status verified

Mar 2022

Primary completion

Sep 30, 2022

Completion

Sep 30, 2022

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Adalimumab
  single dose of adalimumab(160 mg administered as 4×40 mg subcutaneous \[SC\] injections at separate sites on the thigh or abdomen
• Placebo Comparator: Placebo
  single dose of placebo (administered as 4×40 mg subcutaneous \[SC\] injections at separate sites on the thigh or abdomen

Primary Outcome Measure

Establish whether treatment with adalimumab is associated with a lower rate of progression to severe disease as defined by severe illness or critical illness, or death in outpatient subjects with COVID-19 [ Time Frame: 28 Days ]