Evaluation of the melatonin tablet efficacy as an adjuvant therapy for patients with mild to moderate COVID-19

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200408046990N12

Enrollment

Registered

2022-11-15

Start date

2022-10-25

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

COVID-19 pneumonia. COVID-19, virus identified

Interventions

Intervention 1: Intervention group: three melatonin 3mg tablet daily for two weeks. Intervention 2: Control group: placebo with same appearance of melatonin tablet three daily for 2 weeks.

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Clinical or laboratory diagnosis of mild to moderate COVID-19 Age between 18-85 y Sign of written consent

Exclusion criteria

Exclusion criteria: Pregnancy and lactation History of allergy to melatonin Immunosuppression history Lactase deficiency Concomitant use of alcohol and 1A2 inhibitors

Design outcomes

Primary

Measure	Time frame
Fever. Timepoint: Daily. Method of measurement: Thermometer.;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.;Radiologic improvement. Timepoint: Two weeks after treatment. Method of measurement: Lung CT scan.;Laboratory response. Timepoint: Weekly. Method of measurement: Assessment of lymphocyte count.;Drug adverse reaction. Timepoint: Daily. Method of measurement: Patient file and interview.	—

Measure

Time frame

Fever. Timepoint: Daily. Method of measurement: Thermometer.;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.;Radiologic improvement. Timepoint: Two weeks after treatment. Method of measurement: Lung CT scan.;Laboratory response. Timepoint: Weekly. Method of measurement: Assessment of lymphocyte count.;Drug adverse reaction. Timepoint: Daily. Method of measurement: Patient file and interview.

—

Secondary

Measure	Time frame
Duration of the hospitalization. Timepoint: End of the treatment. Method of measurement: Patient's file.;Patient's final outcome. Timepoint: End of the treatment. Method of measurement: Patient's file.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSepideh Elyasi

Mashhad University of Medical Sciences

elyasis@mums.ac.ir+98 51 3180 1588

Outcome results

None listed

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