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 hospitals. All patients who refer to Abadan hospitals in a period of time and their testing is positive, which includes 62 people, who will be in two groups: Doclatasavir + Sophosbovir and Ribavirin.
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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 62 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.
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 and positive RT-PCR assay of nasopharyngeal samples
Exclusion criteria: patients under 18 years, pregnant and breast feeding women
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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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level of consciousness, Respiratory rate, blood pressure and arterial oxygen saturation and changes in laboratory factors, gastrointestinal disorder, number of days of hospitalization and mortality rate.
General information
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Reason for update
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Explain the release schedule as well as update the primary and secondary variables
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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:
2020-05-01, 1399/02/12
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
O2 saturation under 94% or respiratory rate above 24 or decreased level of consciousness
Exclusion criteria:
patients under 18 years
pregnant or breast feeding women
patients did not consent to participate in the study
patients who took any complementary medicine
safety problem for patients
patients with any allergy or hypersensitivity to Sofosbuvir + Daclatasvir or Ribavirin or with major interaction with other medicine
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Age
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From 18 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:
62
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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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Time to clinical improvement defined as start of taking medication time to alive hospital discharge
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Timepoint
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The beginning of the study , the time of discharge and 21 days after discharge
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Method of measurement
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Medical record
Secondary outcomes
1
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Description
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Duration of hospitalization
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Timepoint
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Time of discharge
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Method of measurement
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Number of hospital days
2
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Description
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Duration of stay at ICU
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Timepoint
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Daily
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Method of measurement
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Number of days of hospitalization in ICU
3
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Description
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Mortality rate
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Timepoint
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Daily
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Method of measurement
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Medical record
4
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Description
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Respiratory rate
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Timepoint
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Daily
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Method of measurement
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Count the number of breaths per minute
5
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Description
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laboratory variables
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Timepoint
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The beginning of the study and the time of discharge
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Method of measurement
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Medical record
6
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Description
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Adverse events
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Timepoint
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Time of discharge
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Method of measurement
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Medical record
Intervention groups
1
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Description
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lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose + sofosbuvir (400 mg)- daclatasvir (60 mg) take one tablet daily until clinical symptoms improve
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: lopinavir (50 mg) –ritonavir (200 mg) 2 tablets every 12 hours until the patient's clinical symptoms improve + hydroxychloroquine (200 mg) two tablets one dose + ribavirin (200 mg) 6 tablets every 12 hours until clinical symptoms improve
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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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-All data can be shared after the participants in the study are unrecognizable.
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When the data will become available and for how long
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The data access period after printing the article
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To whom data/document is available
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-The data in this study will be available to researchers working at academic and scientific institutions, as well as the Food and Drug Administration.
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Under which criteria data/document could be used
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- Any analysis can be done with the consent of the main researcher.
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From where data/document is obtainable
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-s.mobarak@abadanums.ac.ir
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What processes are involved for a request to access data/document
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-The researcher or pharmaceutical company can send their request to the academic email after sending the documents to confirm their original identity.
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Comments
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