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Evaluation of the effect of Tofacitinib in covid-19 patients

Evaluation of the effect of Tofacitinib drug (Iranian brand of Rhofanib drug) on clinical and laboratory symptoms in severe and resistant patients with COVID-19

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200531047619N1
Enrollment
10
Registered
2020-10-18
Start date
2020-08-21
Completion date
Unknown
Last updated
2020-11-09

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

Conditions

Coronavirus disease (COVID-19). An emergency ICD-10 code of ‘U07.1 COVID-19, virus identified’ is assigned to a disease diagnosis of COVID-19 confirmed by laboratory testing,An emergency ICD-10 code of ‘U07.2 COVID-19, virus not identified’ is assigned to a clinical or epidemiological d

Interventions

Intervention 1: Intervention group: This group includes severe and ill covid-19 patients who did not respond to routine and existing treatments.In these patients, the Iranian brand of drug tofacitinib

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Severe illness (respiratory rate above 30 per minute, heart rate above 120 per minute and per cent reduction in peripheral oxygen saturation to less than 93%) Patients resistant to existing treatments

Exclusion criteria

Exclusion criteria: Bacterial infection is positive for the patient or procalcitonin is positive The patient may have hepatitis B or hepatitis C or HIV The patient has pulmonary embolism or intravascular thrombosis The patient has active and inactive tuberculosis The patient has diverticulitis and peptic ulcer Leukocytes count less than 3500 cells / mm and hemoglobin less than 9 g / dL and neutrophils less than 1000 cells / mm3

Design outcomes

Primary

MeasureTime frame
Oxygen saturation level. Timepoint: Daily. Method of measurement: Pulse oximetry.;Rate of breaths. Timepoint: Daily. Method of measurement: Number per minute.;Heart Rate. Timepoint: Daily. Method of measurement: Number per minute.;Level of consciousness. Timepoint: Daily. Method of measurement: GCS, Glasgow Coma Scale.

Secondary

MeasureTime frame
Radiographic changes in lung CT scan. Timepoint: The first and fourteenth day of treatment. Method of measurement: Scoring system for determining the amount of grand glass and interstitial lung involvement (by radiologist)(By Radiologist).;Measurement of serum levels of interleukin -1,interleukin- 2, interleukin-6 and TNF-alpha. Timepoint: The first and fourteenth day of treatment. Method of measurement: ELISA test.;Serum ferritin. Timepoint: The first and fourteenth day of treatment. Method of measurement: Micro grams per liter.;D-dimer serum. Timepoint: The first and fourteenth day of treatment. Method of measurement: Micro grams per milliliter.;Hemoglobin. Timepoint: every other day. Method of measurement: gram per deciliter.;White blood cells count. Timepoint: every other day. Method of measurement: Micrograms per liter.;Platelet count. Timepoint: every other day. Method of measurement: Micro grams per liter.;Erythrocyte sedimentation rate. Timepoint: On the first, seventh and fourteenth days of treatment. Method of measurement: Millimeter per hour.;Lactate dehydrogenase(LDH). Timepoint: The first and fourteenth day of treatment. Method of measurement: Micro grams per deciliter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSimin Almasi

Iran University of Medical Sciences

almasi.s@iums.ac.ir+98 21 8214 1600

Outcome results

None listed

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