efficacy and safety of adding fluoxetine to therapeutic regimen of patients with COVID-19 pneumonia

Phase 3

Recruiting

Conditions: Coronavirus disease (COVID-19).
a confirmed diagnosis of the 2019 novel coronavirus disease (COVID-19) as documented by the provider, documentation of a positive COVID-19 test result, or a presumptive positive COVID-19 test result.
U07.1

Registration Number: IRCT20200904048616N1

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of days of hospitalization. Timepoint: Daily from admission. Method of measurement: Number of days of hospital stay until patient's discharge.;Rate of need for intubation. Timepoint: Daily from admission. Method of measurement: Ratio of intubated patients to all of the patients in both intervention and placebo groups.;Mortality rate. Timepoint: Daily during hospitalization. Method of measurement: Ratio of deceased patients to the total number of patients admitted to the study.

Secondary Outcome Measures