Evaluation of the efficacy of melatonin tablets as auxiliary medication in accelerating the improvement of the COVID-19 symptoms and clinical findings: A double-blind randomized and placebo controlled trial
Comparing the effects of melatonin and placebo tablets on the:
1- recovery duration of clinical symptoms (fever, cough and myalgia)
2-improvement time of the laboratory parameters
3-duration of radiology- symptoms remission
Design
The confirmed and suspicious COVID-19 patients who have been admitted to Bohlool Hospital and meet the study criteria are randomly assigned to the two groups of intervention and control. At the group allocation stage, the groups are homogenized in terms of age, gender and illness. Also, the number of confirmed and suspicious patients will be equal in the two groups. Then, for preventing medication interference all the prescriptions are assessed by two specialist doctors.
Settings and conduct
The research will be conducted at Bohlool Hospital.
At admission, all patients are given 200 mg of hydroxychloroquine every 12 hours as the main treatment of COVID-19. Then, the pharmacist will give the two weeks supply of melatonin and placebo tablets to the researcher in numbered packages, neither of them knows the content.
In the medication group, 3 mg melatonin tablets are given three times a day for 2 weeks. In the placebo group, vitamin B containing tablets with the same appearance are given with the same method and duration as the main medicine.
Participants/Inclusion and exclusion criteria
The consent to participate
The confirmed and suspicious COVID-19 patients
Not participating in other clinical trials simultaneously
Intervention groups
Initially, all patients are treated according to the standard treatment of Ministry of Health (Hydroxychloroquine 200 tablets every 12 hours for 14-17 days). Then, the patients are divided into two groups: one group is given the melatonin tablet as an intervention group, the other group will receive a placebo tablet containing vitamin B.
Main outcome variables
COVID-19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046988N1
Registration date:2020-04-29, 1399/02/10
Registration timing:registered_while_recruiting
Last update:2020-04-29, 1399/02/10
Update count:0
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Najmeh Davoudian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 6833
Email address
najmeh.davoudian@gmu.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 the efficacy of melatonin tablets as auxiliary medication in accelerating the improvement of the COVID-19 symptoms and clinical findings: A double-blind randomized and placebo controlled trial
Public title
Evaluation of the efficacy of melatonin tablets as auxiliary medication in accelerating the improvement of the COVID-19 symptoms and clinical findings
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Confirmed and suspicious COVID-19 patients
Not participating in another clinical trial plan simultaneously
Exclusion criteria:
Lack of consent for the study
Changing the other routine medications during the project
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
"Ethics in Research Committee" of Gonabad University of Medical Sciences
Street address
Gonabad University of medical sciences, Asia Ave., Gonabad, Khorasan- e Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.GMU.REC.1399.016
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.01
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Confirmed and possible Coronavirus 2019
Timepoint
at the time of admission
Method of measurement
CT scan - PCR test Corona virus
Secondary outcomes
1
Description
laboratory study
Timepoint
daily
Method of measurement
CBC diff-ABG
Intervention groups
1
Description
Intervention group: Melatonin 3 mg tablets will be given every eight hours for all patients undergoing standard treatment for Qovid 19 (Hydroxychloroquine 200 tablets every 12 hours)
Category
Treatment - Drugs
2
Description
Control group: All patients will be given the standard treatment for Qovid 19 (Hydroxychloroquine 200 tablets every 12 hours). Then placebo tablets with the same shape as the melatonin tablets will be prescribed every 8 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohlool hospital
Full name of responsible person
Najmeh Davoodian
Street address
Saadi St., Vahdat Blvd, Gonabad, Khorasan Razavi,
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6828
Email
najmeh.davoudian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shayla khosravan
Street address
Research and Technology Deputy of Gonabad University of Medical Sciences, Asian Road, Gonabad, Khorasan-E Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5722 3028
Email
khosravan@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Najmeh Davoodian
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Deputy of Educational and Research, Clinical Research Development Unit, , Behlool Hospital, Saadi St., Vahdat Blvd., Gonabad, Khorasan-e Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6828
Email
najmeh.davoudian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Najmeh Davoudian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Deputy of Educational and Research, Clinical Research Development Unit, Behlool Hospital, Saadi St., Vahdat Blvd., Gonabad, Khorasan-e Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Fax
Email
najmeh.davoudian@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Najmeh Davoodian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Deputy of Educational and Research, Clinical Research Development Unit, , Behlool Hospital, Saadi St., Vahdat Blvd., Gonabad, Khorasan-e Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Fax
Email
najmeh.davoudian@gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All the potential collected data will be publishable after making the participants unidentifiable.
When the data will become available and for how long
Due to the importance of studies on COVID-19 immediately after the completion of the study
To whom data/document is available
available for people working in academic institutions or people working in businesses can also apply to receive it
Under which criteria data/document could be used
All analyzes should be performed after coordination with the corresponding author of the project.
From where data/document is obtainable
For information, please refer to the corresponding author of the project, Dr. Najmeh Davoodian najmeh.davoudian@gmail.com
Deputy of Education and Research, Clinical Research Development Unit, , Behlool Hospital, Saadi St., Vahdat Blvd., Gonabad, Khorasan-e Razavi
What processes are involved for a request to access data/document
After receiving the request, based on the importance of the plan, it will be answered within 24-48 hours