COVID-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: Infliximab+ Standard Treatment+ Colchicine? Patients in this group were treated concomitantly with 1 mg of colchicine (for 7 days) with infliximab (single dose of 3
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients with the common type of Novel Coronavirus Pneumonia (NCP) (at high risk) and other severe cases of newly diagnosed coronavirus pneumonia between the ages of 18 and 85 with an increase in IL-6 levels if the patient or his or her judge agrees to participate. Study and after signing the informed consent entered the study. Definition of clinical cases of the novel Coronavirus Pneumonia (NCP) :. 1. Specifications with NCP (with serious risk factors): Contains lung lesions based on common clinical signs of NCP with or without fever. 2. NCP critical patient.
Exclusion criteria
Exclusion criteria: 1. Patients participating in other clinical studies 2. Pregnant or lactating women; 3. Patients receiving immunomodulatory drugs to prevent graft rejection or other cases; 4. Allergy to any of the drug compounds; 5. Patients with active pulmonary tuberculosis, with specific bacterial and fungal infections; Patients with malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of clinical symptoms. Timepoint: Before the intervention and daily during the intervention. Method of measurement: Clinical evaluation of the patient/ Questionnaire.;Evaluation of pulmonary CT scan changes. Timepoint: Before the intervention and every other day during the intervention. Method of measurement: Pulmonary CT scan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of TNF-Alfa level trend. Timepoint: Before receiving the drug and one week after treatment. Method of measurement: Elisa Test.;Evaluation of Interferon Gamma level trend. Timepoint: Before receiving the drug and one week after treatment. Method of measurement: Elisa test.;Evaluation of CRP level trend. Timepoint: Before receiving the drug and one week after treatment. Method of measurement: CRP Test Quantitative/Blood sample.;Evaluation of ESR level trend. Timepoint: Before receiving the drug and one week after treatment. Method of measurement: Westergren method/ Blood sample.;Evaluation of Ferritin level trend. Timepoint: Before receiving the drug and one week after treatment. Method of measurement: Electrochemiluminescence immunoassay.;Evaluation of Adverse Drug Reaction. Timepoint: Daily from the beginning of the intervention. Method of measurement: Naranjo Adverse Drug Reaction Probability Questionnaire.;Evaluation of IL-6 inflammatory factor level trends. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Elisa test.;Evaluation of lymphopenia. Timepoint: Before the intervention and daily during the intervention. Method of measurement: CBC diff test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Farasatinasab
Iran University of Medical Sciences
Outcome results
None listed