Efficacy of Tumor Necrosis Factor alpha inhibitor in COVID-19

Phase 2

Recruiting

• Conditions: COVID-19.; COVID-19; U07.1

• Registration Number: IRCT20200312046749N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 May 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Confirmed the COVID-19 disease with one or more of these: fever, dry cough, dyspnea and one or more of below: positive SARS-COV2 PCR •Characteristic changes of SARS-COV2 in chest CT scan such as bilateral ground grass opacity in bases of the lungs ( confirmation with the radiologist)
Age>18 years old
Signing inform consent from the patient or patient? s accompaniment
No manifestations of bacterial infection
No history of rheumatologic disorders
No history of cancer for the last 1 year.No history of immunodeficiency (primary or acquired)
No manifestations, history and radiologic parameters according to active or latent TB
No diabetes or autoimmune hepatitis
No uveitis
No history of immunosuppressive treatment in the last 6 months
No history of growth hormone, Testosterone and any Anabolic steroids in the last one month
No history of Corticosteroid therapy (>30 mg/m2) for > 5 days in the last one month
No history of Corticosteroid pulses or IVIG treatments for last one month
No history of Biologics treatment for the last 6 months

Exclusion Criteria

Administration of corticosteroids pulses and/or IVIG in the disease process or one month after anti-TNF prescription.
Unwillingness of involved patients to continue this research.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of pulmonary manifestations and the duration. Timepoint: One week, two weeks and 6 months after. Method of measurement: physical examination, labratory data and CT scan.;Improvement the radiologic parameters. Timepoint: after 7-10 days. Method of measurement: computed tomography.;Necessity and Duration to ICU admission and hospitalization. Timepoint: One to two weeks later. Method of measurement: Questionnaire.;Mortality. Timepoint: One month later. Method of measurement: Number.;The three months outcomes: complete improvement; improvement with transient complication; improvement with persistent complication. Timepoint: After three months. Method of measurement: Physical examination and history.