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

Phase 3

Recruiting

• Conditions: COVID-19 pneumonia.; COVID-19, virus identified; U07.1

• Registration Number: IRCT20200408046990N12
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.