COVID-19 pneumonia. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: Patients in treatment group received single dose of adalimumab ampule (CinnoRA, CinnaGen), 40 mg subcutaneously with supportive treatments according to national gui
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement (hospital discharge). Timepoint: Daily until discharge. Method of measurement: Medical record.;Clinical improvement (length of time in which patient needs oxygen therapy). Timepoint: Daily until discharge. Method of measurement: Medical record.;Need for mechanical ventilation. Timepoint: Daily until discharge. Method of measurement: Medical record.;28 days mortality. Timepoint: From the first day of admission until 28 days. Method of measurement: Medical record. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of days admitted to critical care unit. Timepoint: Daily until discharge. Method of measurement: Medical record.;Length of hospital stay. Timepoint: Daily until discharge. Method of measurement: Medical record.;Lung radiological changes. Timepoint: First day of the study then at day 5. Method of measurement: Computed tomography.;RT-PCR result. Timepoint: First day of the study then at day 5. Method of measurement: Medical record. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAtefeh Fakharian
Shahid Beheshti University of Medical Sciences
Outcome results
None listed