1-Determining the clinical effect of Ramdzivir in reducing the load of Covid 19 virus in patients
2- Determining the clinical effect of adding molnopiravir to the treatment regimen containing Ramdzivir in reducing the load of Covid 19 virus in patients
3. Comparison of the clinical effect of Ramdzivir and Ramdzivir with Molnopiravir in reducing the load of Covid virus 19 in patients
4- Determining the side effects of taking Ramdzivir in Covid patients 19
Design
Patients after examination and confirmation of Covid 19 and having entry conditions,According to the simple randomization method, patients are divided into two groups A and B.In the first group, patients receive Ramdzivir in a dose of 200 mg and then 100 mg intravenously daily for up to 5 days.In addition, they receive Mulnopiravir 200 mg every 12 hours for up to 5 days.In the second group, Ramdzivir receive the said dose plus placebo every 12 hours for up to 5 daysThen the tests and ct of the patients are recorded.
Settings and conduct
Patients after examination and confirmation of Covid 19 and having entry conditions,They are included in the study and are prescribed molnopiravir and the patients' symptoms are recorded.
Participants/Inclusion and exclusion criteria
Entry requirements :
1- Patient over 18 years old
2. With moderate Covid 19 who does not need to be hospitalized.
No entry conditions:
1. Patients with critical covid 19
2. Gastrointestinal ulcer or inability to swallow oral medication
3. Thrombocytopenia (platelets less than 100 thousand)
4. Liver enzymes more than 3 times normal
5-GFR <30- or need dialysis
6-Bradycardia (HR <50)
7. Patient dissatisfaction to enter the study
Intervention groups
covid-19patients admitted to the intensive care unit and who had severe respiratory failure
Main outcome variables
improve oxygenation
improve ct scans
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N31
Registration date:2022-01-09, 1400/10/19
Registration timing:registered_while_recruiting
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-16, 1400/09/25
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of molnopiravir for patients with Quid 19
Public title
Evaluation of the therapeutic effect of molnopiravir for patients with Quid 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient over 18 years
With moderate Covid 19 who does not need to be hospitalized.
Exclusion criteria:
Patients with critical covid 19
Gastrointestinal ulcer or inability to swallow oral medication
Thrombocytopenia (platelets less than 100 thousand)
Liver enzymes more than 3 times normal
GFR <30 or require dialysis
Bradycardia (HR <50)
Patient dissatisfaction to enter the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The groups randomization will performed based on the A and B allocation group. this process will managed by computerizing allocation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Street address
End of Niavaran, Darabadational , Research and Treatment center.
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2021-12-09, 1400/09/18
Ethics committee reference number
IR.SBMU.NRITLD.REC.1400.079
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
improve oxygenation
Timepoint
0,1,2,3,5,7 after treatment with Molnopiravir
Method of measurement
pulse oximeter
2
Description
improve ct scan
Timepoint
Five days after starting treatment with mulnopiravir
Method of measurement
CT scan unit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients after evaluation and confirmation of Covid 19 and having entry conditions,Enter the study and then patients are divided into two groups A and B based on simple randomization method.In the first group, patients receive Ramdzivir 200 mg loading dose and then 100 mg intravenously daily for up to 5 days. In addition, they receive mulnopiravir at a dose of 200 mg every 12 hours for up to 5 days.In the second group, Ramdzivir receive the said dose plus placebo every 12 hours for up to 5 days.The rest of the drugs used by the patients are the same in the two groups, then the general condition of the patients, tests and CT scans of the patients are checked.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Full name of responsible person
Dr Seyyed Mohamadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran