Evaluation of Fenofibrate effect on the prognosis in hospitalized patients with COVID-19
Design
A phase 3 double-blinded randomized clinical trial consisted of a placebo group with a total of 69 admitted patients following COVID-19 using the simple randomization method.
Settings and conduct
In this double-blind trial, patient recruitment and treatment were performed in Besat hospital in Tehran. All patients received standard of care according to the last version (8th edition) of the national management protocol for COVID-19 patients. Using the simple randomization method, numbers from 1 to 70 were randomly grouped and patients were consecutively allocated to one of the two study groups based on the table starting from 1. In the intervention group, the patient was given 200 milligrams of Fenofibrate capsule per day orally (each capsule contains 100 milligrams given twice a day) beside usual care. In the control group, the patient received a placebo with a similar appearance to the intervention drug along with the usual care.
For this purpose, we used the following website,
https://www.graphpad.com/quickcalcs/randomize1
The total number of groups (2 groups) and 35 patients in each group were entered and numbers 1, 2, 3... to 70 were assigned to groups A (intervention) and B (control).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged more than 18 years who need hospitalization with a confirmed diagnosis of COVID-19 by RT-PCR.
Exclusion criteria: pregnancy, breastfeeding, hypersensitivity or history of fibrate agents, history of active liver or renal diseases, and hypothyroidism.
Intervention groups
There were two groups in this study including the intervention group receiving Fenofibrate orally and standard of care, and the control group receiving placebo and standard of care.
Main outcome variables
Mortality and need for intensive care unit (ICU)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220612055149N1
Registration date:2022-07-24, 1401/05/02
Registration timing:retrospective
Last update:2022-07-24, 1401/05/02
Update count:0
Registration date
2022-07-24, 1401/05/02
Registrant information
Name
Farbod Hatami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3162 6459
Email address
f.hatami@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-11-05, 1400/08/14
Actual recruitment start date
2021-05-05, 1400/02/15
Actual recruitment end date
2021-11-05, 1400/08/14
Trial completion date
2022-02-12, 1400/11/23
Scientific title
A clinical trial comparing the effect of Fenofibrate on the prognosis in hospitalized patients with COVID-19
Public title
Evaluation of efficacy and safety of Fenofibrate in COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years
Confirmed diagnosis of COVID-19 with RT-PCR
Hospitalization
Symptom onset lower than 10 days
Exclusion criteria:
Pregnancy, breastfeeding
Known hypersensitivity to fibrate agents
History of Fenofibrate treatment
Previous treatment with warfarin, ciclosporin, tacrolimus, and atorvastatin more than 40 milligrams (mg) daily
History of liver diseases, and hypothyroidism
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
70
Actual sample size reached:
69
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method was applied for the current study to determine the study group for each patient (intervention or placebo). Therefore, numbers from 1 to 70 were grouped as intervention or placebo using random allocation. After the patients were enrolled, they were allocated to one of the two study groups using the table of numbers starting from 1.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, the physician, and the outcome assessor were blind as to which study group the patient was allocated. Placebo had similar appearance characteristics including odor and color as the study medication in the intervention group. Placebo and the drug were grouped as A and B as neither the distributor nor the patient knew the labeling information.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of AJA University of Medical Sciences
Street address
West Fatemi St., Shahid Etemadzadeh St.
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-02-17, 1399/11/29
Ethics committee reference number
IR.AJAUMS.REC.1399.240
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Mortality
Timepoint
From admission to 3 months after discharge
Method of measurement
Electronic records and contacting patient after discharge
2
Description
ICU admission
Timepoint
From hospitalization to discharge
Method of measurement
Patient status by electronic records
Secondary outcomes
1
Description
Hospitalization days
Timepoint
At discharge
Method of measurement
Patient electronic records
2
Description
ICU stay
Timepoint
At dischagre
Method of measurement
Patient electronic records
3
Description
Mechanical ventilaton
Timepoint
At discharge
Method of measurement
Need for mechanical ventilation by reviewing electronic records.
Intervention groups
1
Description
Intervention group: Patients admitted following COVID-19 receive 200 milligrams of Fenofibrate capsule by Sobhan Darou including one 100 milligram capsule every 12 hours orally during hospitalization days for a maximum period of 14 days. In both study groups, patients receive further similar treatments according to the national guideline for the standard of care in COVID-19.
Category
Treatment - Drugs
2
Description
Control group: Patients receive an oral placebo by Sobhan Darou every 12 hours. Also, patients receive standard of care treatments as recommended by the national COVID-19 committee and in line with national guidelines similar to those in the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Farbod Hatami
Street address
Hejrat St.
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 56 3162 6459
Email
f.hatami.md@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zoshk
Street address
Shahid Etedmadzadeh St.، West Fatemi St.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Mojtaba.yousefi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Farbod Hatami
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Cardiovascular Diseases Research Center, Razi hospitaم, Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3162 6459
Fax
Email
f.hatami@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sirus Faraji
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Shahid Etemadzadeh St., West Fatemi St.
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 21 8609 6350
Email
Sirus.faraji@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Farbod Hatami
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Cardiovascular Diseases Research Center, Razi hospitaم, Ghaffari St.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3162 6459
Fax
Email
f.hatami@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data regarding clinical outcomes and those variables of clinical importance will be potentially published through a scientific article after making personal data of our patients undetectable.
When the data will become available and for how long
Access date is based on an agreement with the publisher of the scientific article probably after print for a period of 2 years
To whom data/document is available
Faculty of medical universities
Under which criteria data/document could be used
Research purposes
From where data/document is obtainable
Email of the corresponding author: Syrous.faraji@yahoo.com
What processes are involved for a request to access data/document