Evaluating the effect of melatonin as an adjuvant therapy on the mortality and the duration of mechanical ventilation in ICU admitted COVID 19 patients
Design
Permuted block randomization will be used to randomize patients in melatonin and control group. this is an open labeled study without blinding (phase 1 trial with 33 patients)
Settings and conduct
66 intubated patients with COVID-19 infection who admitted to the Intensive care unit (Baharloo hospital, Tehran) were randomized to receive either 21mg melatonin or placebo for 5 days. Patients Main outcomes are the duration of mechanical ventilation requirements, and mortality.
Participants/Inclusion and exclusion criteria
Inclusion critria: all COVID19 patients more than 18 years old at first day of intubation
Excusion critria: hepatic failure- liver enzyme more than 5 time of upper normal limit
Intervention groups
Patients will be randomized to receive either melatonin or placebo
Main outcome variables
Main outcomes are the duration of mechanical ventilation requirements, and mortality.
General information
Reason for update
Acronym
BMCOVID
IRCT registration information
IRCT registration number:IRCT20210225050495N1
Registration date:2021-10-01, 1400/07/09
Registration timing:registered_while_recruiting
Last update:2021-10-01, 1400/07/09
Update count:0
Registration date
2021-10-01, 1400/07/09
Registrant information
Name
Hadiseh Hosamirudsari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6585 0011
Email address
h-hosami@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-11, 1400/05/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of melatonin on mechanically ventilated COVID 19 patients in Intensive care unit
Public title
Evaluating the Effect of melatonin on mechanically ventilated COVID 19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all covid-19 patients admitted to the ICU
Mechanically ventilated patients
within the first 24 hours of intubation
Exclusion criteria:
liver enzyme more than 5 times of normal upper limit
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
patients were randomized using Allocation random software (version 2.0) trough random block sizes of 4 and 6 with an allocation ratio of 1:1, to receive either melatonin or placebo. this is an open labeled study without blinding
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Tehran university of medical sciences
Secondary trial Id
IR.TUMS.VCR.REC.1399.159
Registration date
2020-04-02, 1399/01/14
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences