Assessing the effect of surfactant on clinical outcome in patients with Covid-19 under mechanical ventilation
Design
Two arm parallel group randomized trial with blinded care and outcome assessment
Settings and conduct
COVID-19 patients under mechanical ventilation would enter the study; one group would receive the standard treatment added with placebo and the other group would receive standard care plus intra-tracheal surfactant
Participants/Inclusion and exclusion criteria
Inclusion criteria:
If the patient is intubated and under mechanical ventilation with SpO2<85%
If the patient has confirmed COVID-19
Exclusion criteria:
Existence of a major underlying pulmonary disease in addition to COVID-19
Underlying congenital heart disease
Intervention groups
In the intervention group, based on the dose announced in the study protocol, surfactant is prescribed inside the trachea in two doses at a distance of 6 hours, and at the same time, the dependent variables of the study are measured. At the same time, in the control group, the same volume of normal saline is administered in the trachea within the same time schedule
Main outcome variables
patient mortality; ICU length of stay; Time to be under mechanical ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091201002804N12
Registration date:2020-06-01, 1399/03/12
Registration timing:registered_while_recruiting
Last update:2020-06-01, 1399/03/12
Update count:0
Registration date
2020-06-01, 1399/03/12
Registrant information
Name
Ali Dabbagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2572
Email address
alidabbagh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation
Public title
The effect of surfactant on clinical outcome of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
if the patient is intubated and under mechanical ventilation with SpO2<85%
If the patient has confirmed COVID-19
After the participant enters the study, i.e. after the qualification of the patients in the trial is confirmed and their informed written consent is taken, simple randomization will be done as follows:
1- Table of random numbers will be used for creation of coincidence of random allocation.
2- In order to hide the random allocation process, the central randomization approach will be used, while the random sequence would be at the disposal of one of the researchers except for the principal investigator.
Blinding (investigator's opinion)
Triple blinded
Blinding description
participants after entering the study would not know whether they are in the drug or placebo group
healthcare providers (Physicians and nurses) would administer the prepared vial including drug or placebo while they do not know its content; the vial would be assimilated; regardless of drug or placebo
principle investigator does not know whether the patient belongs to the drug group or the placebo group since the patients have been randomized
Placebo
Not used
Assignment
Factorial
Other design features
COVID-19 treatment study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Deputy for Research and Technology, Shahid Beheshti University of Medical Sciences, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-03-28, 1399/01/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.016
Health conditions studied
1
Description of health condition studied
Mortality of Patients from COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
time for mechanical ventilation
Timepoint
throughout the study, the time that patient has stayed under mechanical ventilation
Method of measurement
clinical records
Secondary outcomes
1
Description
ICU mortality rate
Timepoint
throughout the study in the ICU ward
Method of measurement
clinical records
Intervention groups
1
Description
Intervention group: Intra-tracheal surfactant in COVID-19 patients who are under mechanical ventilation, which includes the administration of a standard dose of surfactant inside the airway of the patient with COVID-19 diagnosis, which is administered immediately on the first day of intubation and in two doses at intervals within 6 hours. The dose of the drug is a vial containing 4 ml, equivalent to 100 mg, which is prescribed for an adult weighing about 70 kg each time, and if the patient's weight is higher, it will be adjusted accordingly. The drug is from the brand Beraksurf® and is supplied by Tekzima.
Category
Treatment - Drugs
2
Description
Control group: all the treatment protocols including standard of care is the same as the treatment group; except for the intrathecal administration of surfactant. An equivalent volume of normal saline is used as placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres hospital
Full name of responsible person
Ali Dabbagh
Street address
Sa'adat Abad
City
Tehran
Province
Tehran
Postal code
1998738341
Phone
+98 21 2207 4100
Fax
+98 21 2207 4101
Email
alidabbagh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Velenjak, Chamran Exp Way
City
Tehran
Province
Tehran
Postal code
1983535511
Phone
+98 21 2387 2202
Fax
+98 21 2387 2202
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Dabbagh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Sa'adat Abad
City
Tehran
Province
Tehran
Postal code
1998738341
Phone
+98 21 2387 2202
Email
alidabbagh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Dabbagh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Sa'adat Abad
City
Tehran
Province
Tehran
Postal code
1998738341
Phone
+98 21 2207 4101
Email
alidabbagh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Dabbagh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Sa'dat Abad
City
Tehran
Province
Tehran
Postal code
1998738341
Phone
+98 21 2207 4101
Email
alidabbagh@yahoo.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 collected deidentified IPD
When the data will become available and for how long
starting in January 2022
To whom data/document is available
the data would be available for people working in academic institutions and people working in businesses
Under which criteria data/document could be used
by formal permission form PI
From where data/document is obtainable
Address of the Principal Investigator
What processes are involved for a request to access data/document