Determining the effect of melatonin on improving the symptoms of patients with COVID-19
Design
Clinical trial with control group, double-blind, randomized, phase 3 on 46 patients. In this study, individuals will be randomly assigned to two groups of intervention and control.
Settings and conduct
This clinical trial will be performed on 46 patients aged 18 to 75 years admitted to the intensive care unit of Vali-e-Asr Hospital of Birjand with a diagnosis of COVID-19. All of the steps will be covered by the patient, physician and evaluators.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 75 years; Diagnosis of COVID-19 in the last 24 hours; One of the three following: respiratory rate more than 30 per minutes, O2 saturation less than or equal to 93% at room temperature, PaO2/FiO2 less than or equal to 300
Exclusion criteria: Patients with shock or hemodynamic instability (increase or decrease in blood pressure and irregular heartbeat); GFR less than 30 ml/minute; History of cirrhosis, hepatitis and severe liver diseases; History of hypertension, depression and epilepsy; Patients with a history of allergic reaction or allergy to melatonin; Patients receiving chemotherapy for cancer; Severe diseases of the immune system; Pregnant and lactating women; Use of alcohol and benzodiazepines
Intervention groups
Intervention group: Melatonin tablet 18 mg at night along with standard treatment for 14 days
Control group: Melatonin placebo tablet 18 mg at night along with standard treatment for 14 days
Main outcome variables
One-month mortality; Duration of hospitalization in the ICU; Clinical symptoms according to the seven-category ordinal scale; Lymphocyte count; PaO2/FiO2 ratio; ESR and CRP levels; AST, ALT and LDH levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150724023315N2
Registration date:2021-07-18, 1400/04/27
Registration timing:prospective
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
Registrant information
Name
Mahmoud Ganjifard
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1338
Email address
ganjim@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of melatonin on improving the symptoms of patients with COVID-19-double-blind randomized clinical trial
Public title
Evaluation of the effect of melatonin in the treatment of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 75 years
Diagnosis of COVID-19 in the last 24 hours
One of the three following: respiratory rate more than 30 per minutes, o2 saturation less than or equal to 93% at room temperature, PaO2/FiO2 less than or equal to 300
Female patients should not be pregnant and should not become pregnant until 30 days after the end of the study
Exclusion criteria:
Patients with shock or hemodynamic instability (increase or decrease in blood pressure and irregular heartbeat)
GFR less than 30 ml/minute
History of cirrhosis, hepatitis and severe liver diseases
History of hypertension, depression (taking fluvoxamine and other potent CYP1A2 inhibitors) and epilepsy
Patients with a history of allergic reaction or allergy to melatonin
Patients receiving chemotherapy for cancer
Severe diseases of the immune system
Pregnant and lactating women
Use of alcohol and benzodiazepines
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups of intervention and control using a random number table. First, we create a variable from 1 to 46 in Excel software. Then we create another variable in another column and generate 23 random numbers one and 23 random numbers two with the randomization command. The numbers of one and two are intervention and placebo groups, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
All of the steps will be covered by the patient, physician and evaluators. Packaging of the drugs will be exactly identical in both arms of the study. Preparation, packaging, and labeling of the drugs will be performed by the third person under the supervision of the senior manager of the project.
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences , Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2020-11-09, 1399/08/19
Ethics committee reference number
IR.BUMS.REC.1399.345
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
One-month mortality
Timepoint
From baseline to end
Method of measurement
Questionnaire
2
Description
Time of death of patients
Timepoint
From baseline to end
Method of measurement
Questionnaire
3
Description
Duration of hospitalization in the ICU
Timepoint
During hospitalization
Method of measurement
Questionnaire
4
Description
Clinical symptoms according to the seven-category ordinal scale
Timepoint
Baseline and then on days 7 and 15
Method of measurement
Questionnaire
5
Description
Lymphocyte count
Timepoint
Baseline and then on days 7 and 15
Method of measurement
Laboratory test
6
Description
PaO2/FiO2 ratio
Timepoint
Baseline and then on days 7 and 15
Method of measurement
Laboratory test
7
Description
ESR and CRP levels
Timepoint
Baseline and then on days 7 and 15
Method of measurement
Laboratory test
8
Description
AST, ALT and LDH levels
Timepoint
Baseline and then on days 7 and 15
Method of measurement
Laboratory test
Secondary outcomes
1
Description
Number of patients who need support through mechanical ventilation
Timepoint
From baseline to end
Method of measurement
Questionnaire
2
Description
Discharge from the hospital
Timepoint
From baseline to end
Method of measurement
Questionnaire
3
Description
Fever relief time in patients who had a fever above 37.5 at the time of admission
Timepoint
During hospitalization
Method of measurement
Questionnaire
4
Description
Adverse effects
Timepoint
On the 15th day
Method of measurement
Common Terminology Criteria for Adverse Event (CTCAE) version 5.0
Intervention groups
1
Description
Intervention group: Six melatonin tablet 3 mg (Razak pharmaceutical company, Tehran, Iran) at night along with standard treatment for 14 days
Category
Treatment - Drugs
2
Description
Control group: Six Melatonin placebo tablet 3 mg (Industrial Laboratory of Mashhad School of Pharmacy, Mashhad, Iran) at night along with standard treatment for 14 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr Educational and Medical Center affiliated to Birjand University of Medical Sciences
Full name of responsible person
Mahmoud Ganjifard
Street address
Vali-e-Asr Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
ganjim@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toba Kazemi
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mahmoud Ganjifard
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Vali-e-Asr Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
ganjim@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahmoud Ganjifard
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Vali-e-Asr Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
ganjim@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahmoud Ganjifard
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Vali-e-Asr Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
ganjim@bums.ac.ir
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
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