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Effects of only Ribavirin and Additional Therapy with dexamethasone on clinical outcome Among Patients With severe Crimean-Congo Hemorrhagic Fever

Protocol summary

Summary
(1) Comparison effect of ribavirin alone and in combination with dexamethasone on clinical outcome of patients with severe form of haemorrhagic Crimean-Congo fever, (2) All patients with severe form of haemorrhagic Crimean-Congo fever C since July 2015 until April 2016 admitted in Boo-Ali infectious diseases hospital-Zahedan, 50 individual in two groups of 25 case, not blinded, block-randomized, single-center, phase 2,(3) The intervention group receive dexamethasone and ribavirin and control group are treated only with ribavirin. Then, mortality, length of hospital stay and the need for blood products used in both groups compared. (4) Inclusion criteria included having at least one criteria of severe form of the disease include severe reduction in platelet count (platelets less than 20,000); signs of bleeding as petechiae, ecchymosis and obvious bleeding; fibrinogen level less than or equal to 120 milligrams per deciliter; partial thromboplastin time more than or equal to 60 seconds; decreased level of consciousness. (5) Ribavirin 30 milligram per killogram for the first dose, then 16 milligram per killogram every 6 hours for 4 days, then 8 milligram per killogram every eight hours for six days as control group and ribavirin as noted in cintrol group in addition to dexamethasone 10 milligram per square meter body. (6) the rate of recovery-death mortality rate and blood products used in both groups recorded and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120525378N1
Registration date: 2016-05-18, 1395/02/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-18, 1395/02/29
Registrant information
Name
Shahab-Aldin Mashaie
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3342 9659
Email address
dr.mashaei@zavms.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical sceinces
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of only Ribavirin and Additional Therapy with dexamethasone on clinical outcome Among Patients With severe Crimean-Congo Hemorrhagic Fever
Public title
Effects of Ribavirin and dexamethasone on clinical outcome of Crimean-Congo Hemorrhagic Fever
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: severe thrombocytopenia (plt<20000); petechiae, ecchymosis or bleeding; low serum levels of fibrinogen (≤120 mg/dl); ptt≥60; Loss of consciousness Exclusion criteria: no sever CCHF (base on SSI criteria); pregnancy; underlying disorder; receive Immunosuppressive drugs; Patients who do not have the necessary cooperation; All patients who received any antiviral , blood or blood products from the onset of symptoms to admission to Boo_Ali hospital; All patients who have not confirmed CCHF
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
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 Zahedan University of Medical sceinces
Street address
Ethics Committee of Zahedan Medical University of Science, Zahedan University of Medical sceinces, Dr.Hesabi Square, Daneshgah Avenue, Zahedan
City
Zahedan
Postal code
Approval date
2015-05-03, 1394/02/13
Ethics committee reference number
IR.ZAUMS.REC.1394.47

Health conditions studied

1

Description of health condition studied
Crimean-Congo Hemorrhagic Fever
ICD-10 code
A98.0
ICD-10 code description
Central Asian haemorrhagic fever

Primary outcomes

1

Description
Mortality rate
Timepoint
After intervention
Method of measurement
Based on the observed and recorded data

2

Description
Need of blood products
Timepoint
After Intervention
Method of measurement
According to transfused units

3

Description
Recovery rate
Timepoint
After intervention
Method of measurement
Based on the observed and recorded data

Secondary outcomes

empty

Intervention groups

1

Description
Control group: ribavirin 30 milligram per kilogram for the first dose then 16 milligram per kilogram every 6 hours for 4 days then 8 milligram per kilogram every eight hours for six days
Category
Treatment - Drugs

2

Description
Intervention group: ribavirin 30 milligram per killogram for the first dose, then 16 milligram per killogram every 6 hours for 4 days, then 8 milligram per killogram every eight hours for six days in addition to dexamethasone 10 milligram per square meter body
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Boo-Ali Hospital of Zahedan
Full name of responsible person
Shahab-Aldin Mashaie
Street address
Amir-Al-Momenin St., Boo-Ali Hospital, Zahedan
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Hesabi Square, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shahab-Aldin Mashaie
Position
Infectious disease Residence
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Dr.Hesabi Sq.,Daneshgah Ave., Zahedan
City
Zahedan
Postal code
Phone
+98 54 3341 5705
Fax
Email
shahabhsm@yahoo.com
Web page address
www.zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shahab-Aldin Mashaie
Position
Infectious Disease Residence
Other areas of specialty/work
Street address
Zahedan Medical University of Science, Dr.Hesabi Sq., Daneshgah Ave., Zahedan
City
Zahedan
Postal code
Phone
+98 54 3341 5705
Fax
Email
dr.mashaei@zaums.ac.ir
Web page address
www.zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shahab-Aldin Mashaie
Position
Infectious Diseases Residence
Other areas of specialty/work
Street address
Zahedan Medical University of Science, Dr.Hesabi Sq., Daneshgah Ave., Zahedan
City
Zahedan
Postal code
Phone
+98 54 3341 5705
Fax
Email
shahabhsm@yahoo.com
Web page address
www.zaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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