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
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
Design
This clinical trial study with control group, phase 3 is performed on 10 patients with severe disease initially. Patients are given 5 mg of Tofacitinib twice daily. If the patients' response to the drug is good during the study, the number of patients in the intervention group will be increased.
Settings and conduct
This study is performed in Firoozgar Hospital in Tehran and the patients are admitted to four ICU wards and two of these wards were considered for the intervention group and the other two for the control group. In the intervention group, Tofacitinib is given at a dose of 5 mg twice a day. Measurement of ferritin, LDH, D-dimer, IL-1, IL-2, IL-6 and TNF alpha will be performed and is repeated on the 14 day. On day one and 14, patients from both groups have a lung CT scan.Finally, statistical reviews and interpretation of information are performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patient satisfaction
2- Severe illness
3 - Leukocytes count above 3500 cells per micro liter and hemoglobin above 9 grams per deciliter of neutrophils above 1000 cells per microliter
Exclusion criteria:
1- Pulmonary embolism or intravascular thrombosis
2- Active infection
3- Diverticulitis and gastric or intestinal ulcers
4 – Active Hepatitis B and hepatitis C and HIV infections
5- Active tuberculosis
Intervention groups
In this study, the intervention is tofacitinib and the intervention group is severe COVID-19 patients.The control group is similar to the intervention group but they are not given tofacitinib.
Main outcome variables
Oxygen saturation
Number of breaths
Heart rate
Level of consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200531047619N1
Registration date:2020-10-18, 1399/07/27
Registration timing:registered_while_recruiting
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Simin Almasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8843 9678
Email address
almasi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2021-02-15, 1399/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of the effect of Tofacitinib in covid-19 patients
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
1-The dose of this drug in patients with rheumatoid arthritis is 5 mg twice a day and in patients with covid-19 the same dose is used for 10 days. 2-In this study, 10 patients are used first, and if the effect of the drug is good in improving patients, the number will be higher.
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
Primary outcomes
1
Description
Oxygen saturation level
Timepoint
Daily
Method of measurement
Pulse oximetry
2
Description
Rate of breaths
Timepoint
Daily
Method of measurement
Number per minute
3
Description
Heart Rate
Timepoint
Daily
Method of measurement
Number per minute
4
Description
level of consciousness
Timepoint
Daily
Method of measurement
GCS, Glasgow Coma Scale
Secondary outcomes
1
Description
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)
2
Description
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
3
Description
Serum ferritin
Timepoint
The first and fourteenth day of treatment.
Method of measurement
Micro grams per liter
4
Description
D-dimer serum
Timepoint
The first and fourteenth day of treatment.
Method of measurement
Micro grams per milliliter
5
Description
hemoglobin
Timepoint
every other day
Method of measurement
gram per deciliter
6
Description
white blood cells count
Timepoint
every other day
Method of measurement
Micrograms per liter
7
Description
Platelet count
Timepoint
every other day
Method of measurement
Micro grams per liter
8
Description
Erythrocyte sedimentation rate
Timepoint
On the first, seventh and fourteenth days of treatment.
Method of measurement
Millimeter per hour
9
Description
Lactate dehydrogenase(LDH)
Timepoint
The first and fourteenth day of treatment.
Method of measurement
Micro grams per deciliter
Intervention groups
1
Description
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 or rhofanib is used and this drug is in the form of 5 mg tablets that are used orally twice a day for fourteen days and the manufacturer of this drug is Alvand Nanotechnology Company.
Category
Treatment - Drugs
2
Description
Control group: In this group, severe and ill COVID-19 patients are admitted to the ICU and received all the routine medications used in ill patients.Tofacitinib given in the intervention group is not given to the control group.