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Effect of Tofacitinib in treatment of Covid-19

Efficacy of Tofacitinib/Remdesivir combination therapy compared to Remdesivir treatment on clinical status and laboratory findings of patients with severe Covid-19: A double-blind randomized clinical trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200426047212N2
Enrollment
60
Registered
2021-11-11
Start date
2021-11-06
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Coronavirus. COVID19, virus identified

Interventions

Intervention 1: Intervention group: Depending on the response to treatment, group 1 will receive Tofacitinib at a dose of 10 mg twice daily (for 5 days) in addition to the 5-day course of Remdesivir (

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: informed written desire and consent to participate in the study Age 18 years or older Hospitalization Severe disease Positive polymerase chain reaction (PCR) test Lung involvement based on CT scan

Exclusion criteria

Exclusion criteria: Death of the patient Physician's diagnosis of not participating in the study History of thrombosis or current thrombosis Suppression of the known immune system Pregnancy and lactation Use of angiotensin converting inhibitors Severe renal, hepatic, respiratory and cardiovascular insufficiency Consumption of cytotoxic drugs Transfer to another hospital

Design outcomes

Primary

MeasureTime frame
Lactate Dehydrogenase. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;Blood Urea Nitrogen. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;Creatinine. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;Alanine Aminotransferease. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;Aspartate Aminotransferase. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;Alkaline Phosphatase. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;C-Reactive Protein. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;White Blood Cell. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;Neutrophil. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;Lymphocytus. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;Red Blood Count. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.;Erythrocyte Sedimentation Rate. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Venous blood test.

Secondary

MeasureTime frame
Respiratory Rate. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Count the respiratory rate per minute.;Percentage of oxygen saturation. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Pulse oximeter.;Heart Rate. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Count the number of heart pumps per minute.;Systolic blood pressure. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Calculate the pressure when the heart contracts.;Body temperature. Timepoint: Before the intervention and one day after the intervention. Method of measurement: Based on thermometer.;Performance status. Timepoint: Before the intervention and one day after the intervention. Method of measurement: According to PRIEST checklist.;State of consciousness. Timepoint: Before the intervention and one day after the intervention. Method of measurement: According to PRIEST checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Dargahi-Malamir

Ahvaz University of Medical Sciences

Dargahi-m@ajums.ac.ir+98 61 3333 3050

Outcome results

None listed

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