Evaluation of melatonin tablet efficacy as an adjuvant treatment for patients with mild to moderate COVID-19 in Qaem and Imam Reza Hospital, Mashhad: A triple-blind randomized placebo controlled clinical trial
Evaluation of the melatonin efficacy as a supplement for treatment of mild to moderate COVID-19
Design
This is a randomized triple-blind, parallel group clinical trial on 40 patients with mild to moderate covid-19 (20 patients in treatment group and 20 patients in placebo group).
Settings and conduct
This study will be performed on 40 patients with clinical or laboratory diagnosis of mild to moderate COVID-19 who refer to Quem or Imam Reza Hospital, Mashhad, Iran. They will received three melatonin 3mg tablet daily for 2 weeks in treatment group or three placebo tablet in placebo group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Laboratory or radiological or clinical diagnosis of mild to moderate COVID-19, age between 18-85y, sign of the written consent
Non-including criteria: pregnancy or lactation, history of allergy to melatonin, concomitant use of alcohol or strong 1A2 inhibitors, immunosuppresion, lactase deficiency
Intervention groups
Treatment group: three melatonin 3mg tablet daily for 2 weeks
Control group: three placebo tablet daily for two weeks
Main outcome variables
Primary endpoints of the study are rates of treatment response and adverse drug reactions. Secondary endpoints are duration of hospitalization and patients' clinical outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046990N12
Registration date:2022-11-15, 1401/08/24
Registration timing:registered_while_recruiting
Last update:2022-11-15, 1401/08/24
Update count:0
Registration date
2022-11-15, 1401/08/24
Registrant information
Name
Sepideh Elyasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1588
Email address
elyasis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-25, 1401/08/03
Expected recruitment end date
2023-10-25, 1402/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of melatonin tablet efficacy as an adjuvant treatment for patients with mild to moderate COVID-19 in Qaem and Imam Reza Hospital, Mashhad: A triple-blind randomized placebo controlled clinical trial
Public title
Evaluation of the melatonin tablet efficacy as an adjuvant therapy for patients with mild to moderate COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical or laboratory diagnosis of mild to moderate COVID-19
Age between 18-85 y
Sign of written consent
Exclusion criteria:
Pregnancy and lactation
History of allergy to melatonin
Immunosuppression history
Lactase deficiency
Concomitant use of alcohol and 1A2 inhibitors
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization using website https://www.sealedenvelope.com With the explanation that each block has 4 members and the shape of the blocks can be as follows: [ABAB], [ABBA, [AABB],[BBAA],[BABA][BAAB] Code A belongs to the intervention group and code B belongs to the control group. the mentioned website selects 10 blocks from Quadruple blocks and patients will be assigned to blocks in the order of entry into the study and finally 40 patients will enter the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The melatonin and the placebo tablets will be packaged in identical-looking bottle and delivered to the clinician. Patients who meet the inclusion criteria will be selected by clinician to be included in the study, randomly assigned to a drug or placebo group and given a bottle with A or B mark. Patients will be evaluated in the course of treatment by the physician and the pharmacy student. Data collection and analysis will be performed by the pharmacy student and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qureshi Building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2020-05-16, 1399/02/27
Ethics committee reference number
IR.MUMS.REC.1399.354
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Fever
Timepoint
Daily
Method of measurement
Thermometer
2
Description
Clinical response to the treatment (including improvement of cough, myalgia, headache, olfactory and taste disorders)
Timepoint
Daily
Method of measurement
Based on patients examination and interview
3
Description
Radiologic improvement
Timepoint
Two weeks after treatment
Method of measurement
Lung CT scan
4
Description
Laboratory response
Timepoint
Weekly
Method of measurement
Assessment of lymphocyte count
5
Description
Drug adverse reaction
Timepoint
Daily
Method of measurement
Patient file and interview
Secondary outcomes
1
Description
Duration of the hospitalization
Timepoint
End of the treatment
Method of measurement
Patient's file
2
Description
Patient's final outcome
Timepoint
End of the treatment
Method of measurement
Patient's file
Intervention groups
1
Description
Intervention group: three melatonin 3mg tablet daily for two weeks
Category
Treatment - Drugs
2
Description
Control group: placebo with same appearance of melatonin tablet three daily for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Quem hospital
Full name of responsible person
Sepideh Hejazi
Street address
Quem Hospital, Ahmadabad Ave., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3180 1588
Email
hejazis@mums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Sepideh Hejazi
Street address
Imam reza Square, Ebne-sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
Phone
+98 51 3854 3031
Email
hejazis@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-mobarhan
Street address
Faculty of Medicine, Ferdowsi University, Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3841 1538
Email
ghayourm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy; Ferdowsi University; Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Ferdosi University, Vakilabad Aven.
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Ferdowsi University, Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information is 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available