Evaluation of the efficiency and safety of favipiravir + hydroxychloroquine drug regimen in comparison with hydroxychloroquine in hospitalized patients with covid-19
determination of the efficiency and safety of favipiravir+hydroxychloroquine in comparison with hydroxychloroquine in hospitalized patients with covid-19
Design
Clinical trial with control group, double-blind, randomized, phase 3 on 50 patients. Table of random numbers are used for randomization.
Settings and conduct
The study is performed in the wards of Shahid Modarres Hospital. Participants, clinical care providers and evaluators of final outcomes are blinded.
Participants/Inclusion and exclusion criteria
Inpatients with COVID-19 in Shahid Modarres Hospital who have the conditions to enter the study:
Inclusion Criteria:
-Respiratory Rate(RR)≥30 /min
-SpO2<93% on room air
-PaO2/FIO2<300
-CT scan Involvement>50%
-Diagnosis confirmed by CPR or CT scan
-Age more than 18 years
- Obtaining the written informed consent from the patient or his/her legal guardian to participate in the clinical trial
Exclusion Criteria:
-G6PD Deficiency
-QT interval more than 450 milliseconds
-myasthenia gravis
-Pregnancy- Breast Feeding
-Severe Renal or Hepatic Failure
Intervention groups
Dosage of the drug in the intervention group: 1600 mg of Favipiravir BD on the first day, 600 mg of Favipiravir BD on the second to fifth day, and concurrent 400 mg of hydroxychloroquine BD on the first day, and 200 mg BD daily on the second to fifth day . The two groups will receive standard treatment (oxygen and, if necessary, antibiotics).
Dosage of the drug in the control group: hydroxychloroquine drug 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to fifth day.
Increase the duration of treatment to 10 days according to the doctor's order.
The control group will receive placebo instead of Favipiravir.
Main outcome variables
- Discharge criteria include: no fever for 3 days, SpO2> 93%, relative improvement in CXR
- All cause Mortality
- Need to Mechanical ventilation
-Drug Adverse Effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200428047228N1
Registration date:2020-05-16, 1399/02/27
Registration timing:prospective
Last update:2020-05-16, 1399/02/27
Update count:0
Registration date
2020-05-16, 1399/02/27
Registrant information
Name
Sanaz Zargar Balaye Jame
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 2959
Email address
sanazzargar@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-19, 1399/02/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficiency and safety of favipiravir + hydroxychloroquine drug regimen in comparison with hydroxychloroquine in hospitalized patients with covid-19
Public title
Evaluation of the efficiency and safety of favipiravir + hydroxychloroquine drug regimen in comparison with hydroxychloroquine in hospitalized patients with covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
a- Respiratory Rate(RR)≥30 /min
b- SpO2<93% on room air
c- PaO2/FIO2<300
d- CT scan Involvement>50%
e- Diagnosis confirmed by CPR or CT scan
f- Age more than 18 years
Exclusion criteria:
a- G6PD Deficiency
b- QT interval more than 450 milliseconds
c- myasthenia gravis
d- Pregnancy- Breast Feeding
e- Severe Renal or Hepatic Failure
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, Random Number Table
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, health care personnel and evaluators of the final outcome are unaware of the drug given to the intervention and control group .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
•Ethics committee of Shahid Beheshti University of Medical Sciences
Intervention group: On the first day, 1600 mg of Favipiravir BD, and on the second to fifth day, 600 mg of Favipiravir BD and concurrent hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to fifth day. The two groups will receive standard treatment (oxygen and, if necessary, antibiotics).
Category
Treatment - Drugs
2
Description
Control group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to fifth day. Increasing the duration of treatment to 10 days, according to the doctor's order. The control group will receive placebo instead of Favipiravir.