Protocol summary

Study aim
Evaluation of isotretinoin effects on Covid-19 disease
Design
This study is A phase 3; non-randomized single-blind clinical trial, 50 patients more than 18 years with positive Covid-19 test will be allocated to either intervention (isotretinoin and standard of care) or routine standard of care.
Settings and conduct
Patients with positive coronavirus infection are included in the study based on PCR and CT scan findings. The onset of symptoms is assessed based on the patient's history, initial imaging findings, and PCR. Patient symptoms including sore throat, dry cough, chills, diarrhea, fever, and other symptoms are recorded. Fifty patients are allocated to intervention and control groups. Twenty-five patients receive 20 mg of isotretinoin twice daily for 7 days along with the standard of care treatment. Other patients receive the standard of care according to the national guidelines. Preliminary data include CT scan findings, clinical signs (fever, fatigue, dry cough, anorexia, shortness of breath, purulent discharge), pulse oximetry findings, and arterial blood gas tests are recorded and analyzed.
Participants/Inclusion and exclusion criteria
Definite Covid-19 disease; older than 18 years; duration of disease less than 48 hours.
Intervention groups
Patients received either Isotretinoin along with the standard of care or standard of care alone according to the national guideline
Main outcome variables
Hypoxia; dyspnea; fever; shivering; cough; fatigue; nausea.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190624043993N3
Registration date: 2020-07-23, 1399/05/02
Registration timing: prospective

Last update: 2020-07-23, 1399/05/02
Update count: 0
Registration date
2020-07-23, 1399/05/02
Registrant information
Name
foroud shahbazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3426 6780
Email address
foroud08@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of isotretinoin effects on treatment of COVID-19 infections
Public title
The evaluation of isotretinoineffects on treatment of COVID-19 infections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive covid-19 test During first 48 hours of symptoms
Exclusion criteria:
Underlying hematologic disease Underlying liver disease Known allergy to Isotretinoin Pregnancy/lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical commitee of Kermanshah University of Medical Sciences
Street address
The vice-chancellor for research and technology, Beheshti Ave, Kermanshah,
City
Kermanshah
Province
Kermanshah
Postal code
6719851351-833
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.KUMS.REC.1399.288

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Virus identified

Primary outcomes

1

Description
Clinical Cure
Timepoint
Seven and 14 days after treatment initiation.
Method of measurement
Clinical and laboratory evaluations.

2

Description
Virological cure
Timepoint
Day 7
Method of measurement
PCR

3

Description
ABG findings
Timepoint
Day 7
Method of measurement
Laboratory assessment

Secondary outcomes

1

Description
Radiological cure, organ dysfunction, death
Timepoint
Day 14
Method of measurement
Clinical and para-clinical data

2

Description
Organ dysfunction
Timepoint
Day 7
Method of measurement
Clinical and laboratory data

3

Description
Death
Timepoint
Day 28
Method of measurement
Observation

Intervention groups

1

Description
Intervention group: Patients with Covid-19 disease will receive 20 mg Isotretinoin twice daily along with the standard of care for 7 days
Category
Treatment - Drugs

2

Description
Control group: Patients with Covid-19 disease will receive the standard of care
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Maria Shirvani
Street address
Farabi Medical education center, Dolat-Abad Boulevard, Isar Square, Kermanshah, Iran.
City
Kermanshah
Province
Kermanshah
Postal code
988338264820
Phone
+98 83 8216 0700
Fax
+98 83 3826 4163
Email
maria_shirvani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Behesti Blve, Vice chancellor for research and technology
City
Kermanshah
Province
Kermanshah
Postal code
083-38370541
Phone
+98 83 3838 4185
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Foroud Shahbazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of pharmacy, Parastar Blve, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
1673-67145
Phone
+98 83 3426 6780
Email
Foroud08@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
ALI akrami
Position
RESIDENT
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
School of medicine, Parastar Blve, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
1673-67145
Phone
+98 83 3426 6780
Email
akramiali7@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Foroud Shahbazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of pharmacy, Parastar Blve, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
1673-67145
Phone
+98 83 3426 6780
Email
Foroud08@gmail.com

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
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