Protocol summary
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Study aim
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Evaluation of the Safety and Efficacy of Sofosbuvir in patients with moderate COVID19, A randomized and Single-blind clinical trial
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Design
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a single-blind randomized controlled study with two parallel arms with 50 patients in each.
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Settings and conduct
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The study will be conducted at Shohada Hospital. Patients will be randomly assigned to the national protocol with or without sofosbuvir in two parallel groups.
Study outcomes will be evaluated over a one-month period. Patients and outcome assessors will be blind using the random codes.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:Both genders, aging from18 to 80 Y.O. who are admitted in hospital , showing at least one of these criteria: Fever (Oral temperature ≥ 38 ℃) , Respiratory rate >24/min , O2Sat<93% in room air or the Pa02/Fi02 ratio ≤300mgHg , Laboratory (RT-PCR) confirming the infection with 2019-Covid Virus , Lung involvement in CT-Scan less than 50 % ( in compliance with the involvement of moderate COVID19 ), 5 ≤days since onset of the COVID19 symptoms ≤10
Exclusion criteria:History of allergic reaction to the drugs used in this clinical trial in a pregnancy or breast feeding status, test Receipt of any experimental treatment for COVID-19 before hand, Heart rate < 60/min, currently on amiodarone prescription, presence of multi organ failure evidence, in need of mechanical ventilation, estimated glomerular filtration rate < 50 0mL/1.73 m2/min , admitted in ICU ward, who are in shock
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Intervention groups
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50 patients admitted in COVID ward from 3/4/2021 with definitive diagnosis of moderate COVID19. For one arm (50 patients) the treatment regimen will consist of interferon+sofosbuvir+national protocol for COVID19 and for the other arm(50 patients) it will be interferion+national protocol for COVID19
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Main outcome variables
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Duration of remission, by length of stay and discharge( if recovery happens)/death
General information
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Reason for update
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اصلاح نحوه کورسازی در مطالعه از دوسر کور به یک سر کور
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180302038915N1
Registration date:
2021-04-05, 1400/01/16
Registration timing:
prospective
Last update:
2022-04-29, 1401/02/09
Update count:
1
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Registration date
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2021-04-05, 1400/01/16
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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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2021-04-14, 1400/01/25
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Expected recruitment end date
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2021-09-16, 1400/06/25
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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 Safety and Efficacy of Sofosbuvir in patients with moderate COVID19, A Single-blind, randomized controlled trial
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Public title
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Safety and efficacy of sofosbuvir in the moderate COVID19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Both genders Age ranging from18 to 80 Y.O. who are admitted in hospital
showing at least one of these criteria: Fever (Oral temperature ≥ 38 ℃) , Respiratory rate >24/min , O2Sat<93% in room air or the Pa02/Fi02 ratio ≤300mgHg
Laboratory (RT-PCR) confirming the infection with 2019-Covid Virus
Lung involvement in CT-Scan less than 50 % ( in compliance with the involvement of moderate COVID19 )
5 ≤days since onset of the COVID19 symptoms ≤10
Exclusion criteria:
History of allergic reaction to the drugs used in this clinical trial
in a pregnancy or breast feeding status
test Receipt of any experimental treatment for COVID-19 before hand
Heart rate < 60/min
currently on amiodarone prescription
presence of multi organ failure evidence
in need of mechanical ventilation
estimated glomerular filtration rate < 50 0mL/1.73 m2/min
admitted in ICU ward
who are in shock
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Age
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From 18 years old to 80 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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- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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by block randomization technique , allocation of the patients will be completely randomized via using a software. there will be 2 arms
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This study will be Single- blinded. Care providers and data analyzers will be blind.
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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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2021-02-21, 1399/12/03
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Ethics committee reference number
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IR.SBMU.RETECH.REC1399.1322
Health conditions studied
1
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Description of health condition studied
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COVID19
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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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Coronavirus infection, unspecified
Primary outcomes
1
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Description
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Time to reach clinical recovery
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Timepoint
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after 10 days on treatment initiation
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Method of measurement
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daily physical exam, assessing vanishing of tachypnea ,blood saturation of O2(using pulse-oximeter) , fever( using thermometer)
Secondary outcomes
1
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Description
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The rate of patients who need to admit in ICU ward
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Timepoint
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14 days after Treatment initiation
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Method of measurement
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physical exam and paraclinical evaluation
2
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Description
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The rate of patient expiry in each arm
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Timepoint
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14 days after treatment initiation
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Method of measurement
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questionnaire
3
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Description
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remission of clinical symptoms in each arm
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Timepoint
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14 days after treatment initiation
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Method of measurement
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physical exam ( thermometer and pulse-oximeter)
Intervention groups
1
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Description
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Intervention group: all the patients are required to fill the consent form to be able to enter the trial. 50 patients admitted in the COVID ward with definitive moderate COVID19 diagnosis and randomly divided into two arms( each with 50 patients). in the intervention arm, the treatment regimen will consist of sofosbuvir, interferon beta 1a, and national protocol for COVID treatment. interferon beta 1a 44 micrograms will be administered subcutaneously 3-5 doses a day and sofosbuvir 400 mg orally and daily for 10 days and paraclinical tests and vital signs and blood O2 saturation will be assessed according to the plan by experienced health providers
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Category
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Treatment - Drugs
2
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Description
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Control group: All the patients are required to fill the consent form to be able to enter the trial. 50 patients admitted to the COVID ward with definitive moderate COVID19 diagnosis and randomly divided into two arms( each with 50 patients). in the intervention arm, the treatment regimen will consist of interferon beta 1a and national protocol for COVID treatment. interferon beta 1a 44 micrograms will be administered subcutaneously 3-5 doses a day for 10 days and paraclinical tests and vital signs and blood O2 saturation will be assessed according to the plan by experienced health providers
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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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Shahid Beheshti 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available