IRCT20151227025726N23CompletedPhase 2
Evaluating the efficacy and safety of Adalimumab in patients with acute respiratory distress syndrome caused by COVID-19
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 65 years (—)
- Sex
- All
Inclusion Criteria
- •Patients between 18 and 65 years old.
- •Laboratory confirmed COVID-19 (Corona Virus Disease-19) with RT-PCR (Real-Time Polymerase Chain Reaction) or CT scan.
- •Sever or critically ill patients.
- •CRP rise two times the normal value.
- •IL-6 above 7 pg/ml.
- •Signed the consent form
Exclusion Criteria
- •Acute or chronic renal failure (creatinine rise above 3 mg/dL during the last 48 hours or GFR les than 30 mL/min)
- •Liver failure (LFT rise five times the upper limit or three time rise in symptomatic patients or Child Pugh C or D)
- •Allergic reaction while injecting adalimimab with severe extravasation or anaphylactic reaction.
- •Patient with mild disease
- •Pregnancy or breastfeeding
- •Patients with IL-6 below 7 pg/ml
- •Patient with latent or active TB or any other active infection
- •History of active pectic ulcer
- •Receiving drugs effective on interleukin or TNF alpha
- •History of malignancy
- •Patient with heart failure
Investigators
Similar Trials
Completed
Phase 2
Adalimumab effectiveness in COVID-19COVID-19.C0VID-19U07.1IRCT20150303021315N22Tehran University of Medical Sciences40
Completed
Not Applicable
The Study for Efficacy and Safety of Adalimumab for Crohn's Disease with Loss of Response to InfliximabCrohn's Disease patient as following 1)or 2) 1)the patient who treated with IFX infusion of interval every 4-6 weeks. 2)the patient who could not keep to treat with IFX due to side effect or ineffectiveness.JPRN-UMIN000005761Kenji Watanabe50
Active, not recruiting
Not Applicable
Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYActive Ankylosing SpondylitisEUCTR2005-004826-21-BEAbbott GmbH & Co. KG1,200
Active, not recruiting
Not Applicable
Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYActive Ankylosing SpondylitisEUCTR2005-004826-21-GBAbbott GmbH & Co. KG1,200
Active, not recruiting
Phase 1
Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis – An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-alpha Inhibitors. - RHAPSODYActive Ankylosing SpondylitisEUCTR2005-004826-21-DKAbbott GmbH & Co. KG1,200