COVID-19 trials registries data warehouse

http://en.irct.ir/trial/46955

Ahmadreza Jamshidi

jamshida@tums.ac.ir

2021-01-27

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

Patients with the ability to comprehend and willingness to participate in the trial‎. Patients who are at least 18 years old at the beginning of trial. Patients with Fever higher than 37.8 C, Cough, shortness of breath accompanied by SpO2 ≤%93, who ‎have a confirmed diagnosis of SARS-CoV-2 infection using RT-PCR. patients with increased level of TNF-alpha to 3 times as much as normal range or with remarkable increase in CRP or Ferritin.

Patients attending other clinical trials at the same time. patients who are pregnant or breastfeeding. patients with (ALT/AST> 5ULN, ANC <0.5 (x109/L), Platelet count<50 (x109/L) based on laboratory findings. People with active immune-related rheumatic diseases who have been treated with anti-TNF medications for the last 6 months. People taking immunosuppressive drugs. People who are allergic to adalimumab or other components of the formulation of these drugs. People with active pulmonary tuberculosis or other active bacterial or fungal infections (Based on IGRA, procalcitonin and blood culture) People with heart failure (grades 3 and 4 of NYHA). History of demyelinating diseases in the patient or his/her family

2

Tehran University of Medical Sciences

18

100

Iran

Severe disease at enrollment

6: Severe disease at enrollment

40

Mortality rate in day 28

Phase 2

[{"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"}]