COVID-19. C0VID-19
Conditions
Interventions
Intervention 1: Intervention group: The intervention group, in addition to standarad treatment, receives 80 mg of adalimumab (with the concentration of 40mg/0.8ml) produced by Cinnagen Company (CinnoR
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality rate in day 28. Timepoint: From day 1 to day 28. Method of measurement: During the hospital stay based on the doctor's approval and then by phone call and taking a history in day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in laboratory data. Timepoint: Day 1, day 3-5 and at the time of discharge. Method of measurement: Laboratory test.;2. Changes in SpO2. Timepoint: Day 1, day 3-5 and at the time of discharge. Method of measurement: Physical examination.;Radiographic changes of the lungs. Timepoint: Day 1 and week 6. Method of measurement: CT-scan.;Duration (days) of supplemental oxygenation. Timepoint: Day 1 to the time of discharge. Method of measurement: Clinical evaluation.;Percent of patients with improvement in oxygenation (at least one step decrease in oxygenation supply). Timepoint: Day 1 to the time of discharge. Method of measurement: Clinical evaluation.;Incidence of any adverse events (AEs) during the study. Timepoint: Day 1 to the time of discharge. Method of measurement: Clinical evaluation.;Changes in findings related to physical examinations and vital signs. Timepoint: Day 1 to day 3-5 and at the time of discharge. Method of measurement: Clinical evaluation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMona Talschian
Tehran University of Medical Sciences
Outcome results
None listed