Reducing in mortality and improve oxygenation in covid-19 patient's
Design
covid-19patients admitted to the intensive care unit and who had severe respiratory failure and lack of adequate response to treatment were included in the group, and a 5 mg 0kg cyclosporine ampoule was gradually infused. The general symptoms of patients and CT scans of patients were noted.
Settings and conduct
Patients admitted to the ICU who have respiratory failure and have not responded to treatment. They are selected and infused with cyclosporine ampule patients and patients' symptoms are noted.
Participants/Inclusion and exclusion criteria
patient's admited in ICU and wards
Intervention groups
covid-19patients admitted to the intensive care unit and who had severe respiratory failure
Main outcome variables
improve oxygenation
improve ct scans
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N22
Registration date:2020-05-25, 1399/03/05
Registration timing:registered_while_recruiting
Last update:2020-05-25, 1399/03/05
Update count:0
Registration date
2020-05-25, 1399/03/05
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
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
Cyclosporin for the Prevention and Treatment of COVID-19 Disease
Public title
Cyclosporin for the Prevention and Treatment of COVID-19 Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
covid patients
non-intubated payients
Age between 18-80
Exclusion criteria:
Allergy to cyclosporin
intubated patients
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Street address
End of Niavaran, Darabadational , Research and Treatment center.
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-04-07, 1399/01/19
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.058
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
improve oxygenation
Timepoint
0,1,2,3,7after treatment with cyclosporin
Method of measurement
pulse oximeter
2
Description
improve ct scan
Timepoint
seven day after cyclosporine treatment
Method of measurement
CT scan unit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patient under cyclosporin treatment: Patients who have acute respiratory failure due to covid-19 and do not respond to antiretroviral therapy due to the unknown nature of the disease to reduce inflammatory cytokines in patients with slow cyclosporine injections within two hours of infusion and seven days continue and the general condition of patients and symptoms Patient and CT-scans are checked
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Full name of responsible person
Dr Seyyed Mohamadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran