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Efficacy of Tumor Necrosis Factor alpha inhibitor in COVID-19

Evaluation the efficacy of Tumor Necrosis Factor alpha inhibitor in COVID-19 outcomes: a prospective clinical trial study.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200312046749N1
Enrollment
80
Registered
2020-03-28
Start date
2020-03-27
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID-19

Interventions

Intervention 1: Intervention group: altebrel 50mg by aryogen company subcutaneously in two dose with2-3 days duration in one week. Intervention 2: Control group: In control group, supportive care and

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahid Ziaee

Tehran University of Medical Sciences

ziaee@tums.ac.ir+98 21 6692 0981

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026