COVID-19 trials registries data warehouse

http://en.irct.ir/trial/51473

Afshin Zarghi

mpd@sbmu.ac.ir

2020-11-10

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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

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

2

Shahid Beheshti University of Medical Sciences

18

65

Iran

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

60

Clinical improvement (hospital discharge) Clinical improvement (length of time in which patient needs oxygen therapy) Need for mechanical ventilation 28 days mortality

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 27, "treatment_name": "Adalimumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]