Determination of the addition of melatonin to routine treatment on treatment outcomes and the quality of sleep in COVID-19 patients
Design
The present study will be a clinical trial study with a parallel design and without blinding.
Settings and conduct
The study will be conducted in Imam Khomeini Hospital of Sari. The first group, in addition to the usual treatment, which includes chloroquine azithromycin and supportive measures, will receive melatonin tablets in the amount of 3 mg at night for 7 days. in this study blindness wont be done
The second group will receive the usual treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: This study will be performed on patients with the new coronavirus (CoV-2019). Subjects will be confirmed using CT scan or PCR findings and will then be included in the study.
Exclusion criteria: Patients who are not confirmed by CT scan and PCR findings will not be included in the study.
Intervention groups
Intervention group: chloroquine + azithromycin + supportive measures + melatonin tablets in the amount of 3 mg at night for 7 days.
Control group: will receive the usual treatment.
Main outcome variables
1- Time to stop the fever
2- Transfer to ICU
3- Mortality
4- Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047030N1
Registration date:2020-04-17, 1399/01/29
Registration timing:registered_while_recruiting
Last update:2020-04-17, 1399/01/29
Update count:0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
Reza Alizadeh-Navaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 7230
Email address
alizadeh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-14, 1399/01/26
Expected recruitment end date
2020-06-15, 1399/03/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of adding melatonin to routine treatment on outcomes and quality of sleep in COVID-19 patients
Public title
The effect of melatonin on the quality of sleep in COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to attend the study
Clinical symptoms
Lymphocyte count less than 1100
Positive CT scan or C-reactive protein
Exclusion criteria:
Epilepsy
Taking warfarin and other anticoagulants and coagulation disorders
Uncontrolled diabetes and high blood pressure
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
N/A
Randomization description
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 Mazandaran University of Medical Sciences
Street address
Moallem Square, Deputy of Research and Technology, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
1920-04-12, 1299/01/23
Ethics committee reference number
IR.MAZUMS.REC.1399.056
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Stop the fever
Timepoint
It will be reviewed for 7 days from the study onset.
Method of measurement
It is recorded by a thermometer.
2
Description
Transfer to ICU
Timepoint
A maximum of 10 days of hospitalization will be checked.
Method of measurement
Tracking hospitalized patients through questions and recording in questionnaires
3
Description
Mortality
Timepoint
A maximum of 10 days of hospitalization will be checked.
Method of measurement
Tracking hospitalized patients through questions and recording in questionnaires
4
Description
Sleep quality
Timepoint
Days 1, 2, 3, and 7.
Method of measurement
The Leeds Sleep Evaluation questionnaire will be used.
Secondary outcomes
1
Description
Lymphopenia status
Timepoint
It will be reviewed on the first day and day 7.
Method of measurement
Cell counter device
2
Description
C-reactive protein status
Timepoint
It will be reviewed on the first day and day 7.
Method of measurement
Serology test
3
Description
Peripheral capillary oxygen saturation (SPO2)
Timepoint
It will be reviewed on the first day and day 7.
Method of measurement
Pulse Oximeter
Intervention groups
1
Description
Intervention group: COVID-19 patients receiving hydroxychloroquine (200 mg every 12 hours), azithromycin (500 mg daily) and melatonin tablets (3 mg every night before bedtime) for up to 7 days
Category
Treatment - Drugs
2
Description
Control group: COVID-19 patients receiving hydroxychloroquine (200 mg every 12 hours) and azithromycin (500 mg daily) for up to 7 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Educational and Medical Hospital in Sari
Full name of responsible person
Reza Alizadeh-Navaei
Street address
Razi Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
reza_nava@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Prof. Majid Saeedi
Street address
Moallem Square
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3448 4800
Email
msaeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Abbas Mousavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mmm89099@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyyed Abbas Mousavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Sari Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mmm89099@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyyed Abbas Mousavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Sari Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mmm89099@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The SPSS data file can be published
When the data will become available and for how long
After publication
To whom data/document is available
Researchers
Under which criteria data/document could be used
Use for review studies
From where data/document is obtainable
Corresponding author E-mail
What processes are involved for a request to access data/document