Evaluation of the effect of melatonin on COVID 19

Evaluation of the effect of melatonin in the treatment of patients with COVID19 compared ?with placebo.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210411050925N1

Enrollment

100

Registered

2022-01-09

Start date

2022-02-20

Completion date

Unknown

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

covid 19. covid 19

Interventions

Intervention 1: Intervention group: Melatonin tablets made by Simorgh Company (6 mg) per night are given to patients until the time of discharge from the ICU. Intervention 2: Control group: Placebo wi

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The inflammatory factors level. Timepoint: At the beginning of the study and 5 day after starting the drug/placebo. Method of measurement: Evaluation of blood levels of inflammatory factors.;Total duration of hospitalization and ICU residency. Timepoint: Determination of hospitalization date,admission to ICU,discharge from ICU,discharge from hospital. Method of measurement: Reading the files.;Oxygenation level. Timepoint: Daily assessment of oxygenation from admission time till discharge. Method of measurement: Pulse oxymetry.	—

Measure

Time frame

The inflammatory factors level. Timepoint: At the beginning of the study and 5 day after starting the drug/placebo. Method of measurement: Evaluation of blood levels of inflammatory factors.;Total duration of hospitalization and ICU residency. Timepoint: Determination of hospitalization date,admission to ICU,discharge from ICU,discharge from hospital. Method of measurement: Reading the files.;Oxygenation level. Timepoint: Daily assessment of oxygenation from admission time till discharge. Method of measurement: Pulse oxymetry.

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Secondary

Measure	Time frame
Measurement of CRP level as inflammatory marker. Timepoint: At the beginning of the study and day 5 after starting the drug/placebo. Method of measurement: Serum level measurement.;Measurement of ESR level as inflammatory marker. Timepoint: At the beginning of the study and day 5 after starting the drug/placebo. Method of measurement: Serum level measurement.;Measurement of LDH level as inflammatory marker. Timepoint: At the beginning of the study and day 5 after starting the drug/placebo. Method of measurement: Serum level measurement.	—

Measure

Time frame

Measurement of CRP level as inflammatory marker. Timepoint: At the beginning of the study and day 5 after starting the drug/placebo. Method of measurement: Serum level measurement.;Measurement of ESR level as inflammatory marker. Timepoint: At the beginning of the study and day 5 after starting the drug/placebo. Method of measurement: Serum level measurement.;Measurement of LDH level as inflammatory marker. Timepoint: At the beginning of the study and day 5 after starting the drug/placebo. Method of measurement: Serum level measurement.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Roham

Iran University of Medical Sciences

rohgam.m@iums.ac.ir+98 21 8214 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026