Umifenovir effectiveness in the treatment of COVID-19

Evaluation of the efficacy and safety of Umifenovir in the treatment of hospitalized patients with covid-19: A randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200322046833N1

Enrollment

100

Registered

2020-04-03

Start date

2020-03-28

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

Covid-19. Covid-19

Interventions

Intervention 1: Intervention group: Hydroxychloroquine 400 mg every 12 hours for the first day then 200 mg every 12 hours Atazanavir / ritonavir 300/100 mg once daily. Arbidol 100 mg(manufactured by P

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >18 years old Patients with a probable and definitive diagnosis of COVID-19 who are candidates for hospitalization and receiving antiviral regimens. Presence of at least one clinical sign (including fever, chills, cough, myalgia) with positive virologic specimen or imaging findings for COVID-19

Exclusion criteria

Exclusion criteria: Patient or fellows' dissatisfaction with entering or continuing the study History or any signs of hypersensitivity to umifenovir Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Clinical improvement includes fever rupture. Timepoint: Since admission to the hospital then daily monitoring. Method of measurement: Physical examination, thermometer, questionnaire.;Clinical improvement includes SPO2 >93%. Timepoint: Since admission to the hospital then daily monitoring. Method of measurement: Physical examination, pulse oxymetery,questionnaire.;Improvement of respiratory symptoms. Timepoint: Since admission to the hospital then daily monitoring. Method of measurement: Physical examination, ct scan,questionnaire.;Adverse effects. Timepoint: Since admission to the hospital then daily monitoring. Method of measurement: Questionnaire, physical examination.	—

Measure

Time frame

Clinical improvement includes fever rupture. Timepoint: Since admission to the hospital then daily monitoring. Method of measurement: Physical examination, thermometer, questionnaire.;Clinical improvement includes SPO2 >93%. Timepoint: Since admission to the hospital then daily monitoring. Method of measurement: Physical examination, pulse oxymetery,questionnaire.;Improvement of respiratory symptoms. Timepoint: Since admission to the hospital then daily monitoring. Method of measurement: Physical examination, ct scan,questionnaire.;Adverse effects. Timepoint: Since admission to the hospital then daily monitoring. Method of measurement: Questionnaire, physical examination.

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Secondary

Measure	Time frame
Duration of hospitalization. Timepoint: 7 days to 1 months after beginning the treatment. Method of measurement: Questionnaire.;Clinical outcome. Timepoint: 7 days to 1 months after beginning the treatment. Method of measurement: Questionnaire.;Lipoxin. Timepoint: day-0, day-2, day-4. Method of measurement: measuring the plasma concentration of the biomarker with ELISA kit.;Prostaglandin. Timepoint: day-0, day-2, day-4. Method of measurement: measuring the plasma concentration of the biomarker with ELISA kit.;Leukotriene. Timepoint: day-0, day-2, day-4. Method of measurement: measuring the plasma concentration of the biomarker with ELISA kit.;Resolvin. Timepoint: day-0, day-2, day-4. Method of measurement: measuring the plasma concentration of the biomarker with ELISA kit.	—

Measure

Time frame

Duration of hospitalization. Timepoint: 7 days to 1 months after beginning the treatment. Method of measurement: Questionnaire.;Clinical outcome. Timepoint: 7 days to 1 months after beginning the treatment. Method of measurement: Questionnaire.;Lipoxin. Timepoint: day-0, day-2, day-4. Method of measurement: measuring the plasma concentration of the biomarker with ELISA kit.;Prostaglandin. Timepoint: day-0, day-2, day-4. Method of measurement: measuring the plasma concentration of the biomarker with ELISA kit.;Leukotriene. Timepoint: day-0, day-2, day-4. Method of measurement: measuring the plasma concentration of the biomarker with ELISA kit.;Resolvin. Timepoint: day-0, day-2, day-4. Method of measurement: measuring the plasma concentration of the biomarker with ELISA kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBita Shahrami

Tehran University of Medical Sciences

bita.shahrami@gmail.com+98 21 2244 5566

Outcome results

None listed

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