Effect of Arbidol in treatment of COVID-19

• Register: IRCT
• Last refreshed on: 17 August 2020
• Main ID: IRCT20180725040596N2
• Date of registration: 2020-04-18
• Prospective Registration: Yes
• Primary sponsor: Iran University of Medical Sciences
• Public title: Effect of Arbidol in treatment of COVID-19
• Scientific title: Evaluation of the effect of Arbidol drug in the treatment of hospitalized patients with COVID-19
• Date of first enrolment: 2020-04-29
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://en.irct.ir/trial/46897
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method: Simple randomization. Unit: Individual. Tools: Random blocks How to build: Using 4 times Blocks (AABB, ABAB, ....) with random selection of block and reading from right to left Allocation concealment will be done by numbered drug cans that are numbered randomly. The cans will be the same weight and shape and will be prepared by an independent researcher.
• Phase: 3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: ?Dr. Mitra Ranjbar
• Affiliation: Iran University of Medical Sciences

• Name: Dr. Marzieh Nojomi
• Affiliation: Iran University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Age equal or greater than 18 years
Signing informed consent
Diagnosis of COVID-19 by chest CT-scan or RT-PCR test
Exclusion criteria: Respiratory failure
People with a history of allergies to this drug and or a history of severe allergies
Patients who used Arbidol (Tablets, capsules, granules) before hospitalization
Women who are breastfeeding or pregnant
Renal or liver function failure
Anemia or thrombocytopenia
Patient who received immunosuppressive drug during 3 months ago
Congenital heart failure
History of arrhythmia
coagulation disorders

Age minimum: 18 years
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

COVID-19.
Coronavirus infection, unspecified

U07.1

Intervention(s)

Intervention 1: Intervention group: 50 patients with COVID-19 will be included in this group and their treatment regimen includes oral Hydroxychloroquine (first day 400 mg/BD and from second day 200 mg/BD) and Arbidol orally at a dose of 200 mg 3 times a day for 5 to 10 days. Intervention 2: Control group: Fifty COVID-19 patients in the control group will be given a treatment regimen of two Kaletra 200/50 mg tablets every 12 hours and Hydroxychloroquine sulfate (single dose 400 mg/ BD for first day) for 5 to 10 days.

Primary Outcome(s)

Chest CT Scan view symptoms. Timepoint: Patient's chest CT scan check at the beginning of the study and 30 days after starting treatment. Method of measurement: Taking a chest CT scan.

Measurement of patients fever. Timepoint: Measurement of patient's body temperature at the beginning of the study and 7 days after starting treatment. Method of measurement: Thermometer.

Determination of C-reactive protein test. Timepoint: Measurement of C-reactive protein level at the beginning of the study and 7 days after starting treatment. Method of measurement: Blood test.

Hospital admission days. Timepoint: check daily. Method of measurement: observation.

Measurement of blood oxygen saturation and no adjuvant oxygen therapy. Timepoint: Measurement of oxygen saturation level at the beginning of the study and 7 days after starting treatment. Method of measurement: Pulse oximeter.

Measurement of complete blood count test. Timepoint: Performing a complete blood cell count test at the beginning of the study and 7 days after starting treatment. Method of measurement: Blood test.

Secondary Outcome(s)

Observing virological results. Timepoint: Measurement of patient's sputum viral load at the beginning of the study and 7 days after starting treatment. Method of measurement: Real-time polymerase chain reaction test.

Patient death. Timepoint: Check daily. Method of measurement: Observation.

Measurement of erythrocyte sedimentation rate test. Timepoint: Measurement of erythrocyte sedimentation rate at the beginning of the study and 7 days after starting treatment. Method of measurement: Blood test.

Source(s) of Monetary Support

Presidential Transformation and Development Cooperation Center

Iran University of Medical Sciences

Secondary Sponsor(s)

Presidential Transformation and Development Cooperation Center

Ethics review

Status: Approved
Approval date: 14/04/2020
Contact:

Ethics Committee of Iran University of Medical Sciences