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Protocol summary
Clinical trial with control group, Randomized, Single-center, Sample size 20 people.
Clinical trial with control group, Randomized, Single-center, Sample size 30 people (2 groups of 15 people).
Clinical trial with control group, Randomized, Single-center, Sample size 2030 people (2 groups of 15 people).
کارآزمایی بالینی با گروه کنترل، تصادفی شده، تك مركزي. حجم نمونه 20 بیمار .
کارآزمایی بالینی با گروه کنترل، تصادفی شده، تك مركزي. حجم نمونه 30 بیمار (2 گروه 15 نفری).
کارآزمایی بالینی با گروه کنترل، تصادفی شده، تك مركزي. حجم نمونه 2030 بیمار (2 گروه 15 نفری).
General information
3
2
32
20
30
2030
Randomization - Add control group
Change the sample size from 20 to 30 people
Randomization - Add control groupChange the sample size from 20 to 30 people
تصادفی سازی - اضافه نمودن گروه کنترل
تغییر تعداد حجم نمونه از 20 به 30 نفر
تصادفی سازی - اضافه نمودن گروه کنترلتغییر تعداد حجم نمونه از 20 به 30 نفر
Health conditions studied
#1
B34.2
U07.01
B34.2U07.01
Coronavirus infection, unspecified
Covid-19 infection
CoronavirusCovid-19 infection, unspecified
Coronavirus
Covid-19
CoronavirusCovid-19
Protocol summary
Study aim
A study on melatonin and Vitamin C and zinc efficacy in patients with COVID19 hospitalized in intensive care unit of Semnan Kowsar Hopsital
Design
Clinical trial with control group, Randomized, Single-center, Sample size 30 people (2 groups of 15 people).
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Covid 19; Conscious consent of the patient.
Exclusion criteria: Malignant diseases; Severe renal, hepatic failure; History of drug allergy.
Intervention groups
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.
Main outcome variables
Number of breaths per minute; The rate of decline of lung infection; The course of the disease; Heart rate.
General information
Reason for update
Change the sample size from 20 to 30 people
Acronym
IRCT registration information
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
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-07, 1399/01/19
Expected recruitment end date
2020-06-08, 1399/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on melatonin and Vitamin C and zinc efficacy in patients with COVID19 hospitalized in intensive care unit of Semnan Kowsar Hopsital
Public title
A study on melatonin and Vitamin C and zinc efficacy in patients with COVID19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Covid 19
Conscious consent of the patient
Exclusion criteria:
Malignant diseases
Severe renal, hepatic failure
History of drug allergy
Age
To 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 2).
Using Excel software to generate random number tables
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-04-07, 1399/01/19
Ethics committee reference number
IR.SEMUMS.REC.1399.005
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.01
ICD-10 code description
Covid-19 infection
Primary outcomes
1
Description
Number of breaths per minute
Timepoint
Before the intervention, from the start of treatment to the patient's recovery
Method of measurement
Vital signs monitoring devices
2
Description
The rate of decline of lung infection
Timepoint
Before the intervention, from the start of treatment to the patient's recovery
Method of measurement
Clinical examination, if necessary, radiography or CT scan
3
Description
The course of the disease
Timepoint
Before the intervention, from the start of treatment to the patient's recovery
Method of measurement
Clinical examination, if necessary, radiography or CT scan
4
Description
Heart rate
Timepoint
Before the intervention, from the start of treatment to the patient's recovery
Method of measurement
Vital signs monitoring devices
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: Patients are treated according to national protocol. Only for comparison with intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Mahboubeh Darban
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
fatemehehsani59@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mahboubeh Darban
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mahboubeh Darban
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mahboubeh Darban
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available