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Evaluation of the Effectiveness of Two Different Regimens Based on Tosilizumab and Baricitinib in Patients with COVID-19

Evaluation of the Effectiveness of Two Different Regimens Based on Tosilizumab and Baricitinib in Patients with COVID-19 Respiratory Distress Syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151227025726N30
Enrollment
60
Registered
2022-02-28
Start date
2022-03-11
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

COVID-19 pneumonia. COVID-19, virus identified

Interventions

Intervention 1: Intervention group: In addition to receiving tosilizumab at a dose of 400 mg by slow intravenous injection, patients receive baricitinib as a dose of 4 mg daily for 14 days or until di

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients between 18 and 100 years old Laboratory confirmed COVID-19 with RT-PCR Be in severe stage of the disease Have signed the consent to participate in the study

Exclusion criteria

Exclusion criteria: Acute or chronic renal failure (Increase in creatinine by more than 3.0 in the last 48 hours or GFR less than 30 mL/min) Liver failure (more than 5-fold increase in liver enzymes in asymptomatic patients or more than 3-fold increase in liver enzymes in symptomatic patients or Child Pugh C, D) Hypersensitivity reaction to tocilizumab or baricitinib with severe extravasation and symptoms of anaphylactic shock Mild stage of the disease Pregnant and lactating patients Patients who have been intubated Patients who are expected to die in the next 48 hours

Design outcomes

Primary

MeasureTime frame
28 days mortality. Timepoint: From the first day of admission until 28 days. Method of measurement: Medical record.;Need for intubation. Timepoint: Daily until discharge. Method of measurement: Medical record.

Secondary

MeasureTime frame
Length of hospital stay. Timepoint: Daily until discharge. Method of measurement: Medical record.;Number of days admitted to critical care unit. Timepoint: Daily until discharge. Method of measurement: Medical record.;Lung radiological changes. Timepoint: First day of the study then at discharge. Method of measurement: Computed tomography.;Need for a second dose of tosilizumab. Timepoint: Daily until discharge. Method of measurement: Medical record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSahar Yousefian

Shahid Beheshti University of Medical Sciences

saahar26@yahoo.com+98 21 2712 2227

Outcome results

None listed

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