COVID-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: Six melatonin tablet 3 mg (Razak pharmaceutical company, Tehran, Iran) at night along with standard treatment for 14 days. Intervention 2: Control group: Six Melato
Sponsors
Birjand University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahmoud Ganjifard
Birjand University of Medical Sciences
Outcome results
None listed