| Trial registration number
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IRCT20210411050925N1 |
Full text link
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/55504
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First author
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr Abbas Motavalian
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Contact
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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research-m@iums.ac.ir
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Registration date
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2022-01-09
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Recruitment status
Last imported at : May 20, 2022, 9:12 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Patients with positive RT-PCR for COVID19
Ability to sign consent and sufficient literacy
No history of melatonin use during the study
Admission in ICU
Age over 20 years
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Exclusion criteria
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Other systemic diseases (such as uncontrollable hypertension, uncontrolled diabetes, depression, elevated liver enzymes more than 3 times normal, cirrhosis, chronic kidney disease with GFR less than 30 cc / min)
Allergy to melatonin
Usage of anticoagulants such as warfarin or heparin with therapeutic doses
Under mechanical ventilation
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Number of arms
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran University of Medical Sciences
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Inclusion age min
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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20
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Inclusion age max
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
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Countries
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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primary outcome
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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The inflammatory factors level.
Total duration of hospitalization and ICU residency.
Oxygenation level.
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Notes
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Jan. 9, 2022, 10 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 779, "treatment_name": "Melatonin", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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