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
Determining the efficacy of Tofacitinib/Remdesivir combination therapy compared to Remdesivir treatment on clinical status and laboratory findings of patients with severe Covid-19
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized block, phase 2-3 on 48 patients. Random chains and concealment codes were produced by the website "www.sealedenvelope.com".
Settings and conduct
This double-blind randomized study is performed in Razi Hospital, Ahvaz. Participants and researchers in this study will be blind to the specificity of study groups. Group 1 receives Tofacitinib at a dose of 10 mg twice daily (for 5 days) in addition to the 5-day course of Remdesivir. Group 2 will also receive Tofacitinib at a dose of 10 mg twice daily (for 5 days) along with a 10-day course of remediation.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Conscious willingness and written consent to participate in the study; Age 18 years or older; Hospitalization; Severity of the disease; Positive polymerase chain reaction (PCR) test; Lung involvement based on CT scan
Intervention groups
Intervention group: Group 1 receives Tofacitinib at a dose of 10 mg twice daily (for 5 days) in addition to the 5-day course of Remdesivir. Group 2 will also receive Tofacitinib at a dose of 10 mg twice daily (for 5 days) along with a 10-day course of remediation.
Control group: Group 3 receives a 5-day course of Remdesivir with a placebo that will be given twice daily for 5 days. Group 4 also receives a 10-day course of Remdesivir with a placebo, which will be given twice a day for 5 days.
Main outcome variables
Number of breaths; Percentage of oxygen saturation; Performance status; State of consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200426047212N2
Registration date:2021-11-11, 1400/08/20
Registration timing:registered_while_recruiting
Last update:2021-11-11, 1400/08/20
Update count:0
Registration date
2021-11-11, 1400/08/20
Registrant information
Name
Ali Hatami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 7153
Email address
hatami_a@shoushtarums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of Tofacitinib in treatment of Covid-19
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of samples to each of the intervention and control groups will be done by random block method and using 4 blocks. Random chains and concealment codes will be generated by www.sealedenvelope.com. To hide the random chain, the method of envelopes in opaque packages is also used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers in this study are blinded to the specialization of study groups, and an independent person from the research team, along with the Intensive Care Fellowship, prescribes the assigned codes to each patient. To ensure the similarity between the drug and the placebo, the placebo will be made by the same drug company and the study drugs will be placed in similar envelopes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2021-10-09, 1400/07/17
Ethics committee reference number
IR.AJUMS.REC.1400.415
Health conditions studied
1
Description of health condition studied
Coronavirus
ICD-10 code
U07. 1
ICD-10 code description
COVID19, virus identified
Primary outcomes
1
Description
Lactate Dehydrogenase
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
2
Description
Blood Urea Nitrogen
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
3
Description
Creatinine
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
4
Description
Alanine Aminotransferease
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
5
Description
Aspartate Aminotransferase
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
6
Description
Alkaline Phosphatase
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
7
Description
C-Reactive Protein
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
8
Description
White Blood Cell
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
9
Description
Neutrophil
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
10
Description
lymphocytus
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
11
Description
Red Blood Count
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
12
Description
Erythrocyte Sedimentation Rate
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Venous blood test
Secondary outcomes
1
Description
Respiratory Rate
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Count the respiratory rate per minute
2
Description
Percentage of oxygen saturation
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Pulse oximeter
3
Description
Heart Rate
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Count the number of heart pumps per minute
4
Description
Systolic blood pressure
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Calculate the pressure when the heart contracts
5
Description
Body temperature
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Based on thermometer
6
Description
Performance status
Timepoint
Before the intervention and one day after the intervention
Method of measurement
According to PRIEST checklist
7
Description
State of consciousness
Timepoint
Before the intervention and one day after the intervention
Method of measurement
According to PRIEST checklist
Intervention groups
1
Description
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 (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously four days later). Group 2, depending on the response to treatment, will receive Tofacitinib at a dose of 10 mg twice daily (for 5 days) along with a 10-day course of Remdesivir (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously on the next nine days) .
Category
Treatment - Drugs
2
Description
Control group: Group 3, depending on the response to treatment, receives a 5-day course of Remdesivir (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously four days later) with placebo, which will be given twice a day for 5 days. Group 4 will also receive a 10-day Remdesivir course (Administration of 200 mg of Remdesivir on the first day and then 100 mg intravenously on the next nine days) with a placebo that will be given twice daily for 5 days.