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Effect of tofacitinib in COVID-19

Effectiveness evaluation of Tofacitinib plus Remdesivir in comparison with Remdesivir in the treatment of adult patients with severe COVID-19 A randomized double-blind placebo-included clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200329046892N2
Enrollment
60
Registered
2021-03-09
Start date
2021-03-15
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

Condition 1: COVID-19. Condition 2: COVID-19. virus identified virus not identified

Interventions

Intervention 1: Intervention group: Tofacitinib10 mg (Rofanib, Nano Alvand ) 1 oral tablet daily + Remdesivir IV 100 mg daily for 14 days or hospital discharge (whichever comes first). Intervention 2

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients with severe Covid-19 admitted to the ICU of Razi Hospital in Rasht for period of March- June 2021 Age greater than or equal to 18 years Patients admitted with the following criteria: fever (oral temperature greater than 37.2 ° C), dry cough, severe tiredness or dyspnea At least one of the following criteria : positive PCR OR lung involvement on chest X-ray / CT scan Absolute lymphocyte count greater than or equal to 200 per cubic millimeter Absolute neutrophil count greater than or equal to 1000 per milliliter Cubic meters Hemoglobin above 8 grams per deciliter

Exclusion criteria

Exclusion criteria: Lack of informed consent Lack of patient cooperation Having pulmonary embolism or intravascular thrombosis Having another active infection Having diverticulitis and gastric ulcer Having tuberculosis or hepatitis B or active hepatitis C or HIV Any major drug interaction between routine patient's drugs with any of the study drugs Pregnancy and lactation Simultaneous presence in other research study

Design outcomes

Primary

MeasureTime frame
The time required to improve clinical symptoms and within 14 days of treatment start. Timepoint: Daily from the first day of intervention. Method of measurement: Physical examination.

Secondary

MeasureTime frame
Body temperature. Timepoint: Daily from the first day of intervention. Method of measurement: Thermometer.;Heart rate. Timepoint: Daily from the first day of intervention. Method of measurement: Pulse oxymeter.;Pulmonary radiological state. Timepoint: Weekly. Method of measurement: CT scan.;Blood pressure. Timepoint: Daily from the first day of intervention. Method of measurement: Barometer.;Mechanical ventilation. Timepoint: Daily from the first day of intervention. Method of measurement: Physical examination.;Duration of hospitalization in the intensive care unit. Timepoint: Daily from the first day of intervention. Method of measurement: Record in the patient file.;Mortality. Timepoint: Daily from the first day of intervention. Method of measurement: Record in the patient file.;Respiration rate. Timepoint: Daily from the first day of intervention. Method of measurement: Count.;Intubation. Timepoint: Daily from the first day of intervention. Method of measurement: Physical examination.;SPO2. Timepoint: Daily from the first day of intervention. Method of measurement: Pulse-oxy meter.;D-Dimer. Timepoint: Every 3 days from the first day of intervention. Method of measurement: Fluorescence immunochromatography.;Creatine phosphokinase. Timepoint: Every 3 days from the first day of intervention. Method of measurement: International Federation of Clinical Chemistry (IFCC).;C reactive protein. Timepoint: Every 3 days from the first day of intervention. Method of measurement: Turbidometry.;Erythrocyte sedimentation rate. Timepoint: Every 3 days from the first day of intervention. Method of measurement: Westergren method.;Ferritin. Timepoint: Every 3 days from the first day of intervention. Method of measurement: Chemiluminescence method.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNematollah Ahangar

Rasht University of Medical Sciences

n.ahangar@gums.ac.ir+98 13 3369 0099

Outcome results

None listed

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