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Protocol summary
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Study aim
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Comparison of the effect of two drugs Daclatasvir + Sofosbuvir and Ribavirin in COVID-19 patients with severe symptoms
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Design
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The study is a open label , non-randomized and parallel clinical trial. The study population includes all patients with COVID-19 referring to Abadan, Khorramshahr and Shadegan hospitals. They visit the hospitals of Abadan, Khorramshahr and Shadegan and their testing is positive, involving 60 people, 30 of whom will be considered for both groups and will be selected using the census method.
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Settings and conduct
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the drug used in this study in both groups is similar in appearance.was performed on 60 patients with severe symptoms of COVID-19 who were admitted to the infectious ward of Ayatollah Taleghani Hospital in Abadan and if they were hospitalized. These patients needed artificial ventilation and intubation and were admitted to the ICU ward for coronary patients.
The study was approved by the Ethics Committee of Abadan University of Medical Sciences. All patients eligible for inclusion in this study were adequately informed about the procedure and side effects of the drugs used, assured of the confidentiality of their information, and then a written consent was obtained. Patients also had the right to withdraw from the research team at any time.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: positive COVID-19 with severe symptoms
Exclusion criteria: Take a drug other than the medication mentioned
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Intervention groups
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The first group: Daclatasvir + Sofosbuvir
The second group: Ribavirin
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Main outcome variables
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Increased level of consciousness, normalized breathing rate, normalized blood pressure and improved arterial oxygen saturation and changes in laboratory factors, reduced gastrointestinal disorder, reduced number of days of hospitalization and reduced mortality.
General information
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Reason for update
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Because of the plan condition randomization and blindness can't be done
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200324046850N2
Registration date:
2020-03-29, 1399/01/10
Registration timing:
registered_while_recruiting
Last update:
2020-04-07, 1399/01/19
Update count:
4
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Registration date
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2020-03-29, 1399/01/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-18, 1398/12/28
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Expected recruitment end date
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2020-04-16, 1399/01/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of Sofosbuvir + Daclatasvir (Sovodac) and Ribavirin in Covid-19 Patients with Severe Symptoms
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Public title
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Comparison of the effect of Sofosbuvir + Daclatasvir (Sovodac) and Ribavirin in Covid-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
COVID-19 patients that have positive PCR test of nasopharyngeal sample or have bilateral multi-lobar ground glass opacity in CT scan
Exclusion criteria:
patients under 14 years
pregnant or breast feeding women
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Age
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From 14 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-18, 1398/12/28
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Ethics committee reference number
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IR.ABADANUMS.REC.1398.113
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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2019-nCOV disease
Primary outcomes
1
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Description
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Number of people recovering from medication
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Timepoint
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14 days
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Method of measurement
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Improve symptoms
Intervention groups
1
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Description
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Intervention group 1: Tablet Sovodak (Sufbosvir 400mg + Daclatasvir 60mg) daily for 5 days
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Tablets Ribavirin 200 mg every 12 hours 1200mg
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Abadan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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When the data will become available and for how long
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To whom data/document is available
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Under which criteria data/document could be used
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From where data/document is obtainable
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What processes are involved for a request to access data/document
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Comments
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