Evaluation of the effect of Arbidol in treatment of covid 19
Design
Clinical trial of Openlabel, Phase 3 in 60 patients. Patients will be divided into two groups without the need for hospitalization and risk factors. In the first group, in addition to supportive treatment, 200mg hydroxychloroquine tablets twice a day for at least 5 days, which may last up to 14 days depending on clinical conditions, and the second group, in addition to hydroxychloroquine 200mg every 12 hours, under Treatment with Arbidol 200mg capsules every 8 hours for 5 days, depending on the patient's clinical condition, may take up to 14 days.
Settings and conduct
Respiratory triage of Imam Khomeini Hospital Complex in Tehran. Patients with a definite or probable diagnosis of covid19 and having risk factor are divided into two groups for out patient treatment.
Participants/Inclusion and exclusion criteria
Patients diagnosed with COVID-19 infection based on PCR test for oropharyngeal and nasopharyngeal secretions and/or
Specific pulmonary involvement in chest ct
Most age is equal to 18 years
The patient has PO tolerance.
Gaining conscious satisfaction from the patient or first-degree relatives responsible for the patient.
No pregnancy and breastfeeding
Do not take antiarrhythmic drugs
Lack of any history of drug sensitivity
Lack of renal failure
Lack of liver failure
Intervention groups
The first group (control) treated with Hydroxychloroquine
The second group (intervention) treated with Hydroxychloroquine with Arbidol
Evaluating effectiveness and safety of Umifenovir in the treatment (COVID-19)infection In patients referred to Tehran Imam Khomeini Hospital Complex
Public title
Effect of Umifenovir in treatment of covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with COVID-19 infection based on PCR test for oropharyngeal and nasopharyngeal secretions or specific lung involvement in chest CT
Age over 18 years
The patient has PO tolerance
Gaining conscious satisfaction from the patient or first-degree relatives responsible for the patient
No pregnancy and breastfeeding
Exclusion criteria:
Alt more than five times normal
Renal failure
History of any drug allergies
Pregnancy and lactation
Use of antiarrhythmic drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, Vice Chancellor for Research
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Deputy of Research and Technology
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-04-12, 1399/01/24
Ethics committee reference number
IR.TUMS.VCR.REC.1399.204
Health conditions studied
1
Description of health condition studied
covid 19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Percentage of people improved with arbidol
Timepoint
5, 7 and 14 days after taking Arbidol
Method of measurement
follow up with phone
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with probable or definitive diagnosis of covid 19 and have risk factor who have been treated with hydroxychloroquine also Received 200 mg arbidol capsule every 8 hours for 7 days. The company of the pharmaceutical is the Pharmstandard.
Category
Treatment - Drugs
2
Description
Control group: Patients with a probable or definitive diagnosis of covid 19 and a risk factor have been treated with hydroxychloroquine, on the first day, they were given 400 mg every 12 hours and then 200 mg every 12 hours for 7 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Respiratory triage of Imam Khomeini Hospital Complex