COVID-19 trials registries data warehouse

http://en.irct.ir/trial/52777

Dr. Majid Saeidi

msaidi@mazums.ac.ir

2021-05-06

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Patient's informed consent to participation in the study Speaking persian Established diagnosis of Covid-19 by a positive PCR or typical signs of the infection in lung ct scan Absence of depression, anxiety or other psychiatric disorders Absence of mental retardation Negative history of using psychotropic medication in the past 8 weeks No history of hepatic, renal or cardiac disorders BMI<30 Negative history of cigarette or other substance use Admission in non-ICU wards at the beginning of the intervention Absence of melatonin in the therapeutic regimen of the patient Fixed therapeutic regimen Not being pregnant at the time of admission

Suffering from the critical form of covid-19 Occurance of drug allergy or severe adverse effects of fluoxetine Necessity of changing the therapeutic regimen Inability in taking oral medications A score of 8 and above in any of HADS components

2

Mazandaran University of Medical Sciences

16

65

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

72

Number of days of hospitalization Rate of need for intubation Mortality rate

Phase 3

[{"arm_notes": "", "treatment_id": 520, "treatment_name": "Fluoxetine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]