Evaluation of the effect of melatonin in the treatment of patients with COVID-19

Phase 3

Recruiting

Conditions: COVID-19.
COVID-19, virus identified
U07.1

Registration Number: IRCT20150724023315N2

Lead Sponsor: Birjand University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 46

Inclusion Criteria

Age 18 to 75 years
Diagnosis of COVID-19 in the last 24 hours
One of the three following: respiratory rate more than 30 per minutes, o2 saturation less than or equal to 93% at room temperature, PaO2/FiO2 less than or equal to 300
Female patients should not be pregnant and should not become pregnant until 30 days after the end of the study

Exclusion Criteria

Patients with shock or hemodynamic instability (increase or decrease in blood pressure and irregular heartbeat)
GFR less than 30 ml/minute
History of cirrhosis, hepatitis and severe liver diseases
History of hypertension, depression (taking fluvoxamine and other potent CYP1A2 inhibitors) and epilepsy
Patients with a history of allergic reaction or allergy to melatonin
Patients receiving chemotherapy for cancer
Severe diseases of the immune system
Pregnant and lactating women
Use of alcohol and benzodiazepines

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One-month mortality. Timepoint: From baseline to end. Method of measurement: Questionnaire.;Time of death of patients. Timepoint: From baseline to end. Method of measurement: Questionnaire.;Duration of hospitalization in the ICU. Timepoint: During hospitalization. Method of measurement: Questionnaire.;Clinical symptoms according to the seven-category ordinal scale. Timepoint: Baseline and then on days 7 and 15. Method of measurement: Questionnaire.;Lymphocyte count. Timepoint: Baseline and then on days 7 and 15. Method of measurement: Laboratory test.;PaO2/FiO2 ratio. Timepoint: Baseline and then on days 7 and 15. Method of measurement: Laboratory test.;ESR and CRP levels. Timepoint: Baseline and then on days 7 and 15. Method of measurement: Laboratory test.;AST, ALT and LDH levels. Timepoint: Baseline and then on days 7 and 15. Method of measurement: Laboratory test.

Secondary Outcome Measures

Name	Time	Method
umber of patients who need support through mechanical ventilation. Timepoint: From baseline to end. Method of measurement: Questionnaire.;Discharge from the hospital. Timepoint: From baseline to end. Method of measurement: Questionnaire.;Fever relief time in patients who had a fever above 37.5 at the time of admission. Timepoint: During hospitalization. Method of measurement: Questionnaire.;Adverse effects. Timepoint: On the 15th day. Method of measurement: Common Terminology Criteria for Adverse Event (CTCAE) version 5.0.