Protocol summary
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Study aim
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A study on melatonin and Vitamin C and zinc efficacy in patients with COVID19 hospitalized in intensive care unit of Semnan Kowsar Hopsital
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Design
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Clinical trial with control group, Randomized, Single-center, Sample size 30 people (2 groups of 15 people).
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Settings and conduct
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Kowsar Hospital in Semnan.
In addition to national protocol medications, patients receive 40 mg of melatonin (2 5 mg tablets every 6 hours) via NG tube. Patients will also receive 2 grams of ascorbic acid per day at 5% dextrose every 6 hours, plus 220 mg of sulfate every 6 hours. The duration of treatment with this medication regimen will be 5 days.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with Covid 19; Conscious consent of the patient.
Exclusion criteria: Malignant diseases; Severe renal, hepatic failure; History of drug allergy.
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Intervention groups
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Intervention group: In addition to national protocol medications, patients receive 40 mg of melatonin (2 5 mg tablets every 6 hours) via NG tube. Patients will also receive 2 grams of ascorbic acid per day at 5% dextrose every 6 hours, plus 220 mg of sulfate every 6 hours. The duration of treatment with this medication regimen will be 10 days.
Control group: Patients are treated according to national protocol. Only for comparison with intervention group.
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Main outcome variables
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Number of breaths per minute; The rate of decline of lung infection; The course of the disease; Heart rate.
General information
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Reason for update
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Change the sample size from 20 to 30 people
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151228025732N52
Registration date:
2020-04-09, 1399/01/21
Registration timing:
registered_while_recruiting
Last update:
2020-05-25, 1399/03/05
Update count:
2
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Registration date
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2020-04-09, 1399/01/21
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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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2020-04-07, 1399/01/19
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Expected recruitment end date
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2020-06-08, 1399/03/19
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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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A study on melatonin and Vitamin C and zinc efficacy in patients with COVID19 hospitalized in intensive care unit of Semnan Kowsar Hopsital
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Public title
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A study on melatonin and Vitamin C and zinc efficacy in patients with COVID19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with Covid 19
Conscious consent of the patient
Exclusion criteria:
Malignant diseases
Severe renal, hepatic failure
History of drug allergy
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Age
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To 65 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:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 2).
Using Excel software to generate random number tables
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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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2020-04-07, 1399/01/19
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Ethics committee reference number
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IR.SEMUMS.REC.1399.005
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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U07.01
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ICD-10 code description
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Covid-19 infection
Primary outcomes
1
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Description
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Number of breaths per minute
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Timepoint
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Before the intervention, from the start of treatment to the patient's recovery
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Method of measurement
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Vital signs monitoring devices
2
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Description
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The rate of decline of lung infection
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Timepoint
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Before the intervention, from the start of treatment to the patient's recovery
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Method of measurement
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Clinical examination, if necessary, radiography or CT scan
3
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Description
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The course of the disease
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Timepoint
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Before the intervention, from the start of treatment to the patient's recovery
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Method of measurement
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Clinical examination, if necessary, radiography or CT scan
4
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Description
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Heart rate
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Timepoint
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Before the intervention, from the start of treatment to the patient's recovery
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Method of measurement
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Vital signs monitoring devices
Intervention groups
1
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Description
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Intervention group: In addition to national protocol medications, patients receive 40 mg of melatonin (Simorgh Pharmaceutical Company); (2 tablets, 5 mg every 6 hours) via NG tube. Patients will also receive 2 grams of ascorbic acid per day at 5% dextrose(Daropakhsh Company) every 6 hours, plus 220 mg of sulfate every 6 hours(Alhawi Company). The duration of treatment with this medication regimen will be 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: Patients are treated according to national protocol. Only for comparison with intervention group.
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Category
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Treatment - Other
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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Semnan 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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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not 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