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Study aim:
Determination of efficacy and safety of colchicine with Infliximab in comparison with Infliximab in the treatment of patients with Covid 19
Design:
The study will be open label and random. Block randomization will be used for randomization. The minimum number of patients in each group will be 35.
Patients are randomly divided into two groups (9 blocks of 4 in each group) by ABAB (blocks with size 4) blocking method and will be entered by census in patients with inclusion criteria.
Settings and conduct:
Group 1: Patients with COVID-19 with inclusion criteria admitted to Firoozgar Hospital will be treated with 1 mg of colchicine (for 7 days) and infliximab (single dose of 300 mg on the first day of treatment) and recommended treatments for COIVD-19.
Group 2: patients will receive standard treatment with Infliximab (single dose of 300 mg on the first day).
Participants/Inclusion and exclusion criteria:
Inclusion criteria:
1. Patients with the common type of Novel Coronavirus Pneumonia (NCP) (with risk factors including increased pulmonary lesions with or without fever) and critical progression of NCP between the ages of 18 and 85 with increased IL-6 levels
Exclusion criteria:
1. Patients participating in other clinical studies
2. Pregnant or lactating women
3. Consumers of immunomodulators to prevent transplant rejection or other cases
4. Sensitivity to any of the medicinal compounds
5. Patients with active pulmonary tuberculosis, specific bacterial and fungal infections; Patients with malignancy
Intervention groups:
Group A: Infliximab+ Standard Treatment+ Colchicine
Group B: Infliximab+ Standard Treatment
Main outcome variables:
Primary Outcomes:
1. Evaluation of clinical symptoms
2. Evaluation of CT scan changes
3. Evaluation of lymphopenia
4. Evaluation of IL-6 level
Secondary Outcomes:
1. Evaluation of TNF-α , Interferon Gamma, CRP, ESR and Ferritin levels
2. Evaluation of drug side effects