Comparison of clinical symptoms of patients with Covid 19 in the studied groups
Comparison of disease severity and status in patients with Covid 19 in the study groups
Comparison of clinical improvement and mortality in patients with Covid 19 in the study groups
Comparison of oxygen saturation levels and body temperature in patients with Covid 19 in the study groups
Comparison of laboratory findings in patients with Covid 19 in each of the studied groups
Determining the relationship between disease severity and clinical status in patients receiving Remdesivir with the interval between the onset of symptoms and the start of treatment with Remdesivir
Design
Nonequivalence group devided trial with 100 patients.
Settings and conduct
The study will be performed in Hajar Hospital in Shahrekord and with following and completing a checklist of clinical and laboratory symptoms.
Participants/Inclusion and exclusion criteria
1.patients aged≥18 years old
2. SARS-CoV-2 infection confirmed by molecular test and including
1.blood oxygen saturation ≤93% in room air، or patients in need of supportive oxygen or ventilation or
2.patients with pulmonary infiltration in radiological studies enrolled in the study.
ٍExcluding criteria:
1.Alanine aminotransferase and Aspartate aminotransferase rising more than 5 times the upper limit of normal
2.Glomerular filtration rate less than 60ml/minute(according to Cockroft-Gault formula)
Intervention groups
1. Patients recieving Remdesivir+ standard care
2. Patients recieving standard care
Evaluation of clinical course and disease consequences with or without Remdesivir intake in patients with COVID-19 infection
Public title
Effect of Remdesivir in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Blood oxygen saturation<93% in room air or patients with patients in need of supportive oxygen or ventilation or
Patients with pulmonary infiltration in radiological studies
Exclusion criteria:
Alanine aminotransferase and Aspartate aminotransferase rising more than 5 times the upper limit of normal
Glomerular filtration rate less than 30ml/minute(according to Cockroft-Gault formula)
Age
From 18 years old
Gender
Both
Phase
4
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
Not used
Assignment
Other
Other design features
Due to the limit in access to Remdesivir, the study is conducted as a Nonequivalence group. Patients hospitalized in drug availability courses were eligible to receive the drug to comply with ethical principles, and patients admitted in other courses received only standard treatments.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences.
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2021-01-05, 1399/10/16
Ethics committee reference number
IR.SKUMS.REC.1399.230
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
mortality or discharge
Timepoint
End of hospitalization period
Method of measurement
Patient file
2
Description
Hospitalization period
Timepoint
Hospitalization to discharge period
Method of measurement
Patient file
3
Description
ICU admission
Timepoint
From Hospitalization to discharge
Method of measurement
Patient file
4
Description
Clinical symptoms
Timepoint
From hospitalization to discharge
Method of measurement
Interview and examination
5
Description
Laboratory data
Timepoint
From hospitalization to discharge
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive Remdesivir and standard care. this group will receive 200 mg of Remdesivir IV for firs day and 100 mg daily for 4 days plus standard care according to national protocol .
Category
Treatment - Drugs
2
Description
Control group: Patients only receiving standard care according to national protocol with suggested dose and duration and do not receive Remdesivir.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Zahra Rezaei
Street address
Parastar street, Hajar hospital
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
rezaeizahra1997@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Mehraban Sadeghi
Street address
Parastar st.
City
Shahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
rezaeizahra1997@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ahmad Reisi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Parastar st.
City
Shahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
rezaeizahra1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ahmad Reisi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 31 3222 0016
Email
b.sh90@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Rezaee
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Parastar st.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
rezaeizahra1997@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
2021-2022
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
I have not decided yet
From where data/document is obtainable
I have not decided yet
What processes are involved for a request to access data/document