The efficacy of Thalidomide in severe Covid19 pneumonia
Design
This study is a two arm parallel group clinical trial that will be done in Khorshid hospital. Randomization is done through block method. Sample size of this study is 60 patients that divided equally into two groups. Both groups treat with the same method, except the case group that receive thalidomide tablet. 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 Khorshid hospital. According to inclusion and exclusion criteria, patients are randomly divided into 2 grups. Both groups receive the same treatment. Trial group will be received thalidomide tablet daily until 14 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- 18-75 year old men and 50-75 year old women admitted in hospital
2-Spo2 less than 85% in admission
3-Clinical symptoms and signs compatible with COVID19 infection and positive PCR test or lung HRCT abnormalities compatible with COVID19 pneumonia
4-No need to intubation in first 24 hour of admission
5-No multiorgan failure at presentation
6- No shock state at presentation
7- Obtained informed consent
Exclusion criteria:
1. Hepatic failure (Child Pugh score ≥ C, AST> 5 times of the upper limit normal)
2. Severe renal dysfunction (GFR less than 30cc per min)
Intervention groups
Both case and control group receive hydroxychloroquine tablet 100 mg BD for 5 days, acetaminophen codeine and syrup Diphenhydramine for symptom control, Antibiotics depend on physician choice (Ceftriaxone, Azithromycin, Vancomycin), Amp Enoxaparin 40 mg SC daily during hospitalization and Amp Methylprednisolone 50 mg IV daily for 7 days. trial group receive thalidomide tablet 100 mg for 14 days.
Main outcome variables
Time to clinical recovery, Intubation rate, Time to intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170207032444N3
Registration date:2020-04-17, 1399/01/29
Registration timing:registered_while_recruiting
Last update:2020-04-17, 1399/01/29
Update count:0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
Mehrzad Salmasi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3263 0366
Email address
m.salmasi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-15, 1399/01/27
Expected recruitment end date
2020-06-16, 1399/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy and safety of Thalidomide in severe Covid19 pneumonia: Arandomized controlled clinical trial
Public title
Thalidomide in COVID19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-75 year old men and 50-75 year old women admitted in hospital
Spo2 less than 85% in admission
Clinical symptoms and signs compatible with COVID19 infection and positive PCR test or lung HRCT abnormalities compatible with COVID19 pneumonia
No need to intubation in first 24 hour of admission
No multiorgan failure at presentation
No shock state at presentation
Obtained informed consent
Exclusion criteria:
Hepatic failure (Child Pugh score ≥ C, AST> 5 times of the upper limit normal)
Severe renal dysfunction (GFR less than 30cc per min)
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done. We use random allocation service for randomization. There is no allocation concealment.
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib street
disease diagnosis of COVID-19 confirmed by laboratory testing.
Primary outcomes
1
Description
efficacy of Thalidomide in severe Covid19 pneumonia
Timepoint
Daily until discharge and then weekly until 28 days
Method of measurement
history, pulse oximetry, sphygmomanometer
Secondary outcomes
1
Description
28 days survival rate
Timepoint
daily until discharge and then weekly until 28 days
Method of measurement
history
Intervention groups
1
Description
Intervention group: Tab Thalidomide ( Talidex) from Alan pharmaceuticals, daily until 14 days. Both case and control group will be received hydroxychloroquine tablet 100 mg BD, methylprednisolon 50 mg IV, antibiotic depend on physician choice (Ceftriaxone, Azithromycin, Vancomycin), Syrup Diphenhydramine and acetaminophen codeine for symptom control and amp Enoxaparin 40 mg SC daily during hospitalization.
Category
Treatment - Drugs
2
Description
Control group: this group doesnt receive extra drugs. Both groups receive tab hydroxychloroquine 200 mg BID for 5 days, Tab Acetaminophen Codeine and syrup diphenhydramine for symptom control, Antibiotics depend on physician choice (Ceftriaxone, Azithromycin, Vancomycin), Amp Enoxaparin 40 mg SC daily during hospitalization and amp Methylprednisolone 50 mg IV daily for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Ramin Sami
Street address
Ostandari street
City
Isfahan
Province
Isfehan
Postal code
1234567891
Phone
+98 31 3222 2127
Email
khorshid@mui.ac.ir
Web page address
https://nour.mui.ac.ir/fa/Contact
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Daneshgah street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
deputy minister of technology research
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
Farzane Ashrafi
Position
Associate Professor of Hematology and Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ostanadari street
City
Isfahan
Province
Isfehan
Postal code
1234567891
Phone
+98 31 3222 2127
Email
farashrafi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
farzane ashrafi
Position
Associate Professor of Hematology and Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ostandari street
City
Isfahan
Province
Isfehan
Postal code
1234567891
Phone
+98 31 3222 2127
Email
farashrafi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrzad Salmasi
Position
Assisstant professor of internal medicine, Isfahan university of medical sciences
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Moshtagh street
City
Isfahan
Province
Isfehan
Postal code
8158177356
Phone
+98 31 3263 0366
Email
mehrzad_salmasi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more informations
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
not shared
When the data will become available and for how long
not shared
To whom data/document is available
not shared
Under which criteria data/document could be used
not shared
From where data/document is obtainable
not shared
What processes are involved for a request to access data/document