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

Efficacy and safety of adding fluoxetine to the therapeutic regimen of hospitalized patients with non critical pneumonia of COVID-19: A double blinded randomized placebo controlled clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200904048616N1
Enrollment
72
Registered
2021-05-06
Start date
2021-05-21
Completion date
Unknown
Last updated
2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Intervention 1: Intervention group: This group will be prescribed with Fluoxetine capsules for 28 days, with 10 milligram for the first 4 days followed by 20 milligram for the rest of the 4 week perio

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Number 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.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactfaranak sedighi tonekaboni

Iran University of Medical Sciences

faranak.sedighi@yahoo.com+98 11 3336 1700

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026