Evaluating the effects of Adalimumab in patients with acute respiratory distress syndrome caused by COVID-19
- Conditions
- COVID-19 pneumonia.COVID-19, virus identifiedU07.1
- Registration Number
- IRCT20151227025726N23
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method umber 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.