COVID-19 trials registries data warehouse

http://en.irct.ir/trial/56143

Toba Kazemi

research@bums.ac.ir

2021-07-18

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

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

2

Birjand University of Medical Sciences

18

75

Iran

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

46

One-month mortality Time of death of patients Duration of hospitalization in the ICU Clinical symptoms according to the seven-category ordinal scale Lymphocyte count PaO2/FiO2 ratio ESR and CRP levels AST, ALT and LDH levels

Phase 3

[{"arm_notes": "", "treatment_id": 779, "treatment_name": "Melatonin", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]