Protocol summary
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Study aim
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Determination of the effect of sofosbuvir/daclatasvir in COVID-19 patients
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Design
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A clinical trial with a, with parallel control group, double-blind, randomized, phase 3, and multicenter groups per 1000 patients.
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Settings and conduct
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The study is a double-blind clinical trial. The sample size is 1000. The patients are selected according to the eligibility criteria and are assigned to the intervention and control groups by a simple random method. participants, researchers, Care providers, Data analyzers, and outcome assessors are blind. The drugs used were similar in appearance.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age: >=18, One of the following signs: Fever ≥ 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea, CT appearance compatible with COVID, O2Sat 94% or less
Exclusion criteria:
Renal failure (eGFR < 30) Bradycardia (HR < 50), Taking amiodarone, Previous sofosbuvir use, Pregnancy/lactation, Multi-organ failure on admission (2 organs or more, excluding lung), Requiring intubation on admission, Significant arrhythmia in EKG, Allergy to sofosbuvir or daclatasvir, not consenting to the study
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Intervention groups
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Intervention group: Country Standard Pharmaceutical Protocol + SOF/DCV (400mg/60mg) one tablet daily for 10 days.
Control group: Country Standard Pharmaceutical Protocol + placebo one tablet daily for 10 days.
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Main outcome variables
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Recovery within 10 days since the start of taking medicine. Recovery defined as:
(No fever, No dyspnea, No or improved cough, No or improved fatigue, PO tolerance) for 24 hours
General information
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Reason for update
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Edit the Recruitment centers
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Acronym
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DISCOVER
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IRCT registration information
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IRCT registration number:
IRCT20200624047908N1
Registration date:
2020-07-05, 1399/04/15
Registration timing:
prospective
Last update:
2020-11-09, 1399/08/19
Update count:
6
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Registration date
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2020-07-05, 1399/04/15
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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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2020-07-13, 1399/04/23
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Expected recruitment end date
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2020-09-08, 1399/06/18
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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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Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients: a double-blind randomized clinical trial
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Public title
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Evaluation of the effect of sofosbuvir/daclatasvir in COVID-19 patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age ≥18
One of the following signs: Fever ≥ 37.8°C at any one time, Dry cough, Severe fatigue, Dyspnea
CT appearance compatible with COVID
O2 Saturation 94% or less
Exclusion criteria:
Renal failure (eGFR < 30)
Bradycardia (HR < 50)
Taking amiodarone
Previous sofosbuvir use
Pregnancy/lactation
Multi-organ failure on admission (2 organs or more, excluding lung)
Requiring intubation on admission
Significant arrhythmia in EKG
Allergy to sofosbuvir or daclatasvir
Not consenting to the study
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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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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
1000
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This study will be a randomized, double-blind, phase 3, and multicenter clinical trials on 1000 patients. The randomization method is block randomization and the block size is 4. Sealed envelopes are used for the allocation concealment.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study participants, researchers, Care providers, Data analyzers, and outcome assessors are blind. The medicine and placebo are similar in appearance, so patients do not understand which group they are in.
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Placebo
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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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2020-06-21, 1399/04/01
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Ethics committee reference number
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IR.ABADANUMS.REC.1399.071
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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COVID-19
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ICD-10 code description
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U07.1
Primary outcomes
1
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Description
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Recovery within 10 days of starting the drug. Recovery means: (no fever, no shortness of breath, no cough or improved, no fatigue or improved, tolerated oral nutrition) for 24 hours.
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Timepoint
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Daily
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Method of measurement
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Clinical observation and examination
Secondary outcomes
1
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Description
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Recovery within 14 days from start of medication
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Timepoint
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Daily
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Method of measurement
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Clinical observation and examination
2
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Description
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Rate of survival
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Timepoint
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Daily
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Method of measurement
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census report
3
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Description
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Days admitted in hospital
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Timepoint
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Daily since hospitalization time
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Method of measurement
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Based on patient's file
4
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Description
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Days intubated/under ventilator
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Timepoint
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Daily
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Method of measurement
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observation
5
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Description
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Days admitted in ICU
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Timepoint
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Daily
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Method of measurement
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Based on patient's file
Intervention groups
1
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Description
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Intervention group: Country Standard Pharmaceutical Protocol + SOF/DCV (400mg/60mg) one tablet daily for 10 days
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Category
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Treatment - Drugs
2
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Description
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Control group: Country Standard Pharmaceutical Protocol + placebo one tablet daily for 10 days.
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Category
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Placebo
1
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Sponsor
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Grant name
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ITPC-2020
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Grant code / Reference number
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ITPC-2020
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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International Treatment Preparedness coalition
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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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Foreign
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Category of foreign source of funding
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UN agencies and international organizations
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Country of origin
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Type of organization providing the funding
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Other
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 publishing of the article
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To whom data/document is available
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The data in this study will be available for researchers working in 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 by main researcher permission.
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From where data/document is obtainable
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gholamali.eslami1351@gmail.com
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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 of project manager. After ensuring the accuracy of the submitted documents, the project manager will provide the requested information to the researcher or pharmaceutical company in of one week.
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Comments
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