Protocol summary
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Study aim
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Evaluation the effect of one new trial drug on the clinical and paraclinical symptoms in hospitalized patients with COVID-19
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Design
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A randomized controlled, double blind clinical trial with a parallel-group design; consisted of 120 patients, in which participants will be randomly allocated into trial groups using www.randomization.com
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Settings and conduct
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This study is a randomized controlled two blinded trial that will be conducted on COVID-19 patients who referred to Ali Asghar Hospital of Shiraz in two groups (intervention and control groups). The patients, researcher, monitoring committee, and statistical analyst will be blind to the received active drug or placebo. Participants will be allocated into trial groups randomly using randomization site. Patients will receive a drops containers of new trial drug or placebo by giving 6 sublingual drops every 3hours for 14days. Random allocation sequences will be generated by the non-involved person in the research. Both groups will receive routine treatments.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients aged 15 years and older with COVID-19 who had hospitalized; Having a definite disease; Having a signed informed consent form to participate in the study; Non-inclusion:not participation in another clinical trial simultaneously.
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Intervention groups
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In the intervention group, participants will receive six drops containing 433±5 mg sublingual new trial drug every 3 hours for 14 days. The control group will receive a placebo, resembled ِherbal medicine with the same prescription. Both groups will receive routine treatments.
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Main outcome variables
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Respiratory Rate (RR); Oxygen saturation (SpO2); Serum white blood cell count; serum CRP level; ٍُESR; the number of hospitalization days; Mortality
General information
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Reason for update
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Change the scientific title of the experiment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200509047373N2
Registration date:
2021-04-13, 1400/01/24
Registration timing:
prospective
Last update:
2021-10-13, 1400/07/21
Update count:
3
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Registration date
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2021-04-13, 1400/01/24
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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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2022-06-02, 1401/03/12
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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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Effect of new trial drug on improving of clinical and paraclinical symptoms in patients ICU with COVID-19
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Public title
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Effect of new trial drug on clinical and paraclinical symptoms 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:
Having definite COVID-19 disease and get hospitalized
Both sexes
Age over 15 years
Obtaining informed consent to participate in the trial
Non-participation in another clinical trial simultaneously
Patients admitted to ICU
Exclusion criteria:
Diagnosis of the disease just based on physician diagnosis
Pregnancy (according to the patient's statement and examination by a physician)
Breastfeeding (according to the patient's statement)
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Age
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From 15 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
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be allocated to trial groups (intervention and placebo groups) randomly trough site www.randomization.com block sizes of 4 with an allocation ratio of 1:1. Patients will receive a new trial drug sublingual 433 ± 5 mg or placebo . 6 sublingual drops will be taken every 3hour for 14days . Random sequencing allocation will be produced by the person who has not to participate in the research. drops will be numbered from 1 to 120 according to the sequence generated. Both groups will receive routine treatments.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study is a randomized controlled two-blind clinical trial. This means that patient, researcher, safety and data monitoring committee, clinical caregiver and statistical analyst will be blind to the received medication. Each person will be given a new trial drug or placebo in the identical shape and weight.
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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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2021-03-15, 1399/12/25
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Ethics committee reference number
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IR.SUMS.REC.1399.1367
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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COVID-19, virus identified
Primary outcomes
1
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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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Observation
2
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Description
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Oxygen saturation (SpO2)
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Timepoint
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Daily
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Method of measurement
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Pulse Oximeter
3
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Description
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Serum White Blood Cell count
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Timepoint
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Before intervention and 14 days after intervention
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Method of measurement
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Laboratory cell counter
4
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Description
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Serum CRP level
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Timepoint
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Before intervention and 14 days after intervention
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Method of measurement
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Biochemical method
5
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Description
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ESR (Erythrocyte Sedimentation Rate)
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Timepoint
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Before intervention and 14 days after intervention
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Method of measurement
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Checking the sedimentation rate of erythrocytes in a special tube within one hour
6
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Description
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Number of hospitalization days
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Timepoint
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After intervention
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Method of measurement
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Questionnaire
7
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Description
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Mortality
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Timepoint
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Daily
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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The end time of dry Cough
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Timepoint
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Daily
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Method of measurement
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ِDaily symptom recording questionnaire
2
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Description
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The time of recovery from difficulty in breathing or shortness of breath
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Timepoint
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Daily
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Method of measurement
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Daily symptom recording questionnaire
3
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Description
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The time of recovery of temperature equal to or grater than 37.8 C
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Timepoint
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Daily
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Method of measurement
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Daily symptom recording questionnaire
Intervention groups
1
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Description
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In the intervention group, participants will receive new trial drug 6 drops every 3hours for 14 days. The control group will receive a placebo (no therapeutic value), resembled the herbal medicine with the same prescription. Both groups will receive routine treatments.
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Category
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Treatment - Drugs
2
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Description
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Control group: The control group will receive a placebo, resembled the new trial drug with the same prescription. Both groups will receive routine treatments.
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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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Grant code / Reference number
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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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Health Medicine Chemistry Company
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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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Private
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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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Persons
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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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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No - There is not a plan to make this available
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Title and more details about the data/document
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All participants' data can be shared after it becomes unrecognizable
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When the data will become available and for how long
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End of october
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To whom data/document is available
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healthcare professional- َacademic members of universities
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Under which criteria data/document could be used
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An official request from the organization
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From where data/document is obtainable
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Shiraz University of Medical Sciences
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What processes are involved for a request to access data/document
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In case of requesting data for the study, the applicant must first introduce himself or herself and the relevant organization to determine the purpose of the data request and state for what purpose this data is used.After submitting the request, if the researchers of this study prove that the data of this study can advance the therapeutic goals, the information will be sent as long as the data remains confidential.This process takes two weeks.
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Comments
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