Effect of Thalidomide on moderate COVID-19 pneumonia
Design
Clinical trial with control group with parallel groups, phase 2-3 on 100 patients
Settings and conduct
This study is performed in Taleghani Hospital in Tehran on patients with moderate pneumonia caused by Covid-19. Patients will be treated with thalidomide or placebo tablets and the rate of recovery and death will be recorded and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definitive laboratory results based on Covid-19, radiographic results indicating the presence of injury and lung infection, less than 5 days have passed since the confirmation of the disease, moderate disease severity
Exclusion criteria: pregnancy, lactation, receiving thalidomide or other experimental drugs related to the treatment of Covid-19 in the period before the inclusion of the study
Intervention groups
Intervention group: Patients in this group will receive 100 mg thalidomide tablets orally for 14 days in addition to other routine treatments for pneumonia caused by Covid-19. Patients' recovery rate as well as their mortality will be measured and evaluated.
Control group: Patients in this group will receive placebo pills for 14 days in addition to routine treatments for pneumonia caused by Covid-19, and the patients' recovery rate as well as their mortality will be measured and evaluated.
Main outcome variables
Recovery rate and mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051574N5
Registration date:2021-09-13, 1400/06/22
Registration timing:prospective
Last update:2021-09-13, 1400/06/22
Update count:0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4005
Email address
mohammadsharifi.ghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-22, 1400/06/31
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Thalidomide on moderate COVID-19 pneumonia
Public title
Thalidomide and moderate COVID-19 pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive laboratory results for Covid-19
Radiographic results of lung injury and infection
Less than 5 days have passed since the confirmation of the infection
Moderate disease severity based on the World Health Organization classification criteria
Exclusion criteria:
Pregnancy
Breastfeeding
Receive thalidomide or other experimental drugs related to the treatment of Covid-19 within one month prior to enrollment
Existence of a history of thromboembolism unrelated to recent Covid-19 disease
History of interstitial lung disease
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshgah Ave., Tehran
City
Tehran
Province
Isfehan
Postal code
8174673461
Approval date
2021-02-13, 1399/11/25
Ethics committee reference number
IR.SBMU.MSP.REC.1399.684
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Complete clinical recovery time
Timepoint
After interventions
Method of measurement
Examination and clinical signs
2
Description
Mortality rate
Timepoint
After interventions
Method of measurement
Patients' records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will receive 100 mg thalidomide tablets made by Kobel Daru Company orally for 14 days along with other routine treatments for pneumonia caused by COVID-19, such as antibiotics and fluid therapy. Patients' recovery rate as well as their mortality will be measured and evaluated.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will receive placebo tablets for 14 days in addition to routine treatments for pneumonia caused by Covid-19, such as antibiotics and fluid therapy and the patients' recovery rate as well as their mortality will be measured and evaluated.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleqani hospital
Full name of responsible person
MehdiMohammadsharifi
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Tehran
City
Tehran
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Shahid Beheshti University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Tehran
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Esfahan University of Medical Sciences
Full name of responsible person
Ghasem Mohammadsharifi
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
6719675333
Phone
+98 31 3729 4005
Fax
Email
mohammadsharifi.ghasem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghasem Mohammadsharifi
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
6719675333
Phone
+98 31 3729 4005
Fax
Email
mohammadsharifi.ghasem@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ghasem Mohammadsharifi
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
6719674553
Phone
+98 31 3729 4005
Fax
Email
mohammadsharifi.ghasem@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data after the individuals are unidentified can be shared
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.