Protocol summary
-
Study aim
-
Evaluation of the effect of Tranilast on the effectiveness of antiviral drug treatment in patients with severe COVID19
-
Design
-
This study is a two arm parallel group clinical trial that will be done in Ahvaz hospital. Randomization is done through block method. Sample size of this study is 60 patients that divided equally into two groups)intervention and control group
. intervention and control group treat with the same method, except the case group that receive300 mg daily for 7 days (100 mg PO TDS). This a phase 3 clinical trial. In both groups clinical outcome and side effects are evaluated.
-
Settings and conduct
-
A randomized clinical trial that will be done in َAhvaz hospital. According to inclusion and exclusion criteria, patients are randomly divided into 2 grups. Both groups receive the same treatment. Intervention group will receive 300 mg daily for 7 days (100 mg PO TDS).Participants in this study, as well as outcome assessors, were kept blind
-
Participants/Inclusion and exclusion criteria
-
.Age ≥18 years
Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19
Lung involvement confirmed with chest imaging Hospitalized with:Cough Less than 8 days since illness onset Willingness of study
participant to accept randomization to any assigned treatment arm Acceptance of non-participation in another study before the 28th day of the study؛
-
Intervention groups
-
Both intervention and control group receive routine treatment for two weeks. Intervention group receive 3 Tranilast tablet 100 mg for 7 days.
-
Main outcome variables
-
Time to clinical recovery,respiratory signs، Intubation rate,Number of ICU-admitted patients، Duration of ICU-admission، neutrophil-lymphocyte ratio (NLR), erythrocyte sedimentation rate (ESR) ، C-reactive protein (CRP).
General information
-
Reason for update
-
In order to record the clinical trial information more accurately, some changes in the study design, inclusion and exclusion criteria have been updated. The ICD-10 code description was revised.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200419047128N1
Registration date:
2020-04-22, 1399/02/03
Registration timing:
prospective
Last update:
2021-07-04, 1400/04/13
Update count:
1
-
Registration date
-
2020-04-22, 1399/02/03
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-05-04, 1399/02/15
-
Expected recruitment end date
-
2020-11-05, 1399/08/15
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Assessment of the effect of Tranilast (novel NLRP3 Inflammasome inhibitor ) on the efficacy of antiviral drug regimens in the treatment of patients with severe COVID19
-
Public title
-
Tranilast in COVID19
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Age ≥18 years
Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19
Lung involvement confirmed with chest imaging Hospitalized with: Fever Or Cough Less than 8 days since illness onset
Willingness of study participant to accept randomization to any assigned treatment arm
Acceptance of non-participation in another study before the 28th day of the study
arterial blood O2 saturation under 93%
non-pregnant females
Exclusion criteria:
Autoimmune diseases (lupus, MS, etc.)
Hepatic failure
Hepatit B, C,
pregnant and lactating women
use of antioxidants, anti-inflammatory and immunosuppressant drugs
kidney failure
known allergy to Tranilast
-
Age
-
From 18 years old to 85 years old
-
Gender
-
Both
-
Phase
-
2-3
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Patients are divided into two Therapeutic groups by random method and used 6 blocks method. Individuals are the randomization unit , making a random sequence is by using statistical software(WinPepi11.0). Allocation concealment is by assigning unique codes
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-04-11, 1399/01/23
-
Ethics committee reference number
-
IR.AJUMS.REC.1399.050
Health conditions studied
1
-
Description of health condition studied
-
COVID19
-
ICD-10 code
-
U07.1
-
ICD-10 code description
-
COVID-19, virus identified
Primary outcomes
1
-
Description
-
ICU-admitted patients
-
Timepoint
-
after treatment
-
Method of measurement
-
Record information in a checklist by a trained nurse
2
-
Description
-
Duration of ICU-admission
-
Timepoint
-
after treatment
-
Method of measurement
-
Record information in a checklist by a trained nurse
3
-
Description
-
deaths
-
Timepoint
-
After the intervention until the 28th day
-
Method of measurement
-
Record information in a checklist by a trained nurse
4
-
Description
-
neutrophil-lymphocyte ratio (NLR)
-
Timepoint
-
End of day 7
-
Method of measurement
-
White blood cell count
5
-
Description
-
C-reactive protein
-
Timepoint
-
End of day 7
-
Method of measurement
-
ELISA
Secondary outcomes
1
-
Description
-
Blood oxygen saturation percentage
-
Timepoint
-
Before and ten days after starting treatment
-
Method of measurement
-
Pulse oximeter
2
-
Description
-
IL1
-
Timepoint
-
Before and 7 days after starting treatment
-
Method of measurement
-
ELISA (enzyme-linked immunosorbent assay)
3
-
Description
-
IL6
-
Timepoint
-
Before and 7 days after starting treatment
-
Method of measurement
-
ELISA (enzyme-linked immunosorbent assay)
4
-
Description
-
CBC
-
Timepoint
-
Before and 7 days after starting treatment
-
Method of measurement
-
Cell Counter
5
-
Description
-
TNF
-
Timepoint
-
Before and 7 days after starting treatment
-
Method of measurement
-
ELISA (enzyme-linked immunosorbent assay)
6
-
Description
-
D-dimer
-
Timepoint
-
Before and 7 days after starting treatment
-
Method of measurement
-
ELISA (enzyme-linked immunosorbent assay)
7
-
Description
-
SGPT
-
Timepoint
-
Baseline and days 7
-
Method of measurement
-
blood biochimecal test
8
-
Description
-
SGOT
-
Timepoint
-
Baseline and days 7
-
Method of measurement
-
blood biochimecal test
Intervention groups
1
-
Description
-
Intervention group: 3 Tabs Tranilast ( TAIYO ) from Takeda Pharmaceutical, daily until 7 days. Both intervention and control groups will be received routine drugs.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: this group doesnt receive extra drugs. Both groups receive routine drugs.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Ahvaz University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available