Evaluation of the Effect of Ticoplanin in Patients With Coronavirus Disease
Design
A clinical trial with controlled group، not blinded، randomized
Settings and conduct
This study will be performed in Rasoul Akram Hospital Tehran. 40 patients will be divided into two groups (20 in each group) by simple randomization. Patients in the control group will be prescribed a standard regimen for COVID-19. The intervention group will be prescribed teicoplanin 400 mg IV one time daily for seven days and standard regimen for COVID-19. The routine lab data blood cell count, ESR, CRP, CT scan of lungs, hospitalization period, and mortality rate, clinical improvement and radiology finding will be assessed in both groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Laboratory confirmed COVID-19 with RT-PCR or CT scan;
Exclusion criteria: Chronic kidney Disease، Acute kidney injury، Pregnancy or breastfeeding
Intervention groups
Control group: will receive standard regimen for COVID-19. Teicoplanin group: will receive standard regimen for COVID-19 plus teicoplanin 400 mg/daily for 7 days.
Main outcome variables
Clinical symptoms، The change of pneumonia severity on CT scanning، Laboratory and radiologic finding changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161204031229N3
Registration date:2020-04-08, 1399/01/20
Registration timing:registered_while_recruiting
Last update:2020-04-08, 1399/01/20
Update count:0
Registration date
2020-04-08, 1399/01/20
Registrant information
Name
Azadeh Eshraghi
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy-International Campus, Iran University of Medica
Country
Iran (Islamic Republic of)
Phone
+98 86709
Email address
eshraghi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-30, 1399/01/11
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
Study of the Efficacy of Teicoplanin on mortality rate of patients with COVID-19 Infection: A randomized clinical trial
Public title
Evaluation the Effect of Ticoplanin in Patients With Coronavirus Disease
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory confirmed COVID-19 with RT-PCR
Laboratory confirmed COVID-19 with lung CT scan
randomization to intervention and control groups. Simple randomization will be generated with a computer
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.IUMS.REC.1399.058
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Measurement of inflammatory markers (CRP)
Timepoint
at baseline and discharge time
Method of measurement
ELISA
2
Description
WBC count
Timepoint
at baseline and discharge time
Method of measurement
Blood count
3
Description
Evaluation of lung CT scan
Timepoint
at baseline and discharge time
Method of measurement
Radiologic finding
4
Description
Evaluation of inflammatory marker ESR
Timepoint
at baseline and discharge time
Method of measurement
Blood count
Secondary outcomes
1
Description
Body temperature
Timepoint
at baseline and discharge time
Method of measurement
Thermometer
2
Description
Fever
Timepoint
at baseline and discharge time
Method of measurement
Thermometer
3
Description
Respiratory rate >24/min
Timepoint
at baseline and discharge time
Method of measurement
Counting of respiratory rate in minutes
4
Description
Systolic blood pressure <90 mm Hg
Timepoint
at baseline and discharge time
Method of measurement
Manometer
5
Description
Oxygen saturation
Timepoint
at baseline and discharge time
Method of measurement
oximeter Pulse
6
Description
Pulse rate
Timepoint
at baseline and discharge time
Method of measurement
Counting of pulse rate in minutes
7
Description
Level of consciousness or new confusion
Timepoint
at baseline and discharge time
Method of measurement
With glasgow coma scale
Intervention groups
1
Description
Intervention group: Tab Hydroxychloroquine 200 mg two tablet P.O. BID for first day then 200 mg BID seven days plus Tab Lopinavir-Ritonavir 200/50 mg P.O. two tablets BID for seven days or Tab atazabavir-ritonavir 100/300 mg P.O one tablet daily for seven days plus Teicoplanin IV 400 mg daily for 1 weeks.
Category
Treatment - Drugs
2
Description
Control group: Tab Hydroxychloroquine 200 mg two tablet P.O. BID for first day then 200 mg BID seven days plus Tab Lopinavir-Ritonavir 200/50 mg P.O. two tablets BID for seven days or Tab atazabavir-ritonavir 100/300 mg P.O one tablet daily for seven days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasoole Akram Hospital
Full name of responsible person
Azadeh Eshraghi، Saeed Kalantari
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 2564
Email
aepharm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Azadeh Eshraghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2564
Email
aepharm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Eshraghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran