Evaluation of the efficiency of hydroxychloroquine drug regimen in comparison with hydroxychloroquine + azithromycin in hospitalized patients with covid-19 in the intensive care unit
Determination of the efficiency of hydroxychloroquine drug regimen in comparison with hydroxychloroquine + azithromycin in hospitalized patients with covid-19 in the intensive care unit
Design
Clinical trial with control group, double-blind, randomized, phase 3 on 40 patients. Table of random numbers are used for randomization.
Settings and conduct
The study is performed in the ICU 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 ICU of Shahid Modarres Hospital
- Inclusion criteria:
Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive PCR test for COVID-19;
Requiring hospitalization on the basis of level of consciousness,blood pressure, kidney and liver failure؛
age between 16 and 100 years؛
Signed informed consent form;
-Exclusion criteria:
Chronic liver or renal failure;
HIV;
Pregnancy& Breast feeding;
QT interval > 500 ms.
Intervention groups
Dosage of the drug in the intervention group: 400 mg of hydroxychloroquine BD on the first day, and 200 mg BD daily on the second to seventh day and concurrent, Azithromycin at a dose of 500 mg on the first day and then 250 mg daily until the seventh day .
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 seventh day. Increase the duration of treatment to 10 days according to the doctor's order. The control group will receive placebo instead of Azithromycin.
Main outcome variables
Duration of hospital stay in the intensive care unit, death in hospital, response to treatment based on radiological (CT scan) and laboratory criteria, fever, shortness of breath, Oxygen saturation without supplemental oxygen for 5 minutes, drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200428047228N2
Registration date:2020-06-10, 1399/03/21
Registration timing:registered_while_recruiting
Last update:2020-06-10, 1399/03/21
Update count:0
Registration date
2020-06-10, 1399/03/21
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 of hydroxychloroquine drug regimen in comparison with hydroxychloroquine + azithromycin in hospitalized patients with covid-19 in the intensive care unit
Public title
Hydroxychloroquine in comparison with hydroxychloroquine + azithromycin in patients with covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
Requiring hospitalization on the basis of level of consciousness,blood pressure, kidney and liver failure
Patient's age between 16 and 100 years
Signed informed consent form
Exclusion criteria:
Chronic liver and kidney failure
HIV patients
pregnancy and breast feeding
QT interval more than 500 milliseconds
Age
From 16 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, Random Number Table
The numbers will be assigned to the participants who have the inclusion criteria to enter the study, respectively, and according to the table of random numbers, the participants will be divided into two groups of intervention and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, health care personnel and evaluators of the final outcome are unaware of the drug and placebo 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
Radiological Treatment Response (CT scan) , more than 50% reduction in the affected area
Timepoint
CT scan will be done twice (once at the time of admission and the second time 10 days after discharge). Assessment will be done comparing the second CT with the first one
Method of measurement
Patient CT scan
3
Description
Laboratory Treatment Response; return of blood cell count and CRP values to normal
Timepoint
Daily
Method of measurement
Laboratory kits
4
Description
Fever
Timepoint
Daily
Method of measurement
Patient medical records
5
Description
Dyspnea
Timepoint
Daily
Method of measurement
Patient medical records
6
Description
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Timepoint
4 times a day while in the wards
Method of measurement
Observation
7
Description
Adverse drug reactions
Timepoint
Daily
Method of measurement
Adverse Drug Reaction forms
Intervention groups
1
Description
Intervention group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to seventh day and concurrent, Azithromycin at a dose of 500 mg on the first day and then 250 mg daily until the seventh day . The two groups will receive standard treatment
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 seventh day. Increasing the duration of treatment to 10 days, according to the doctor's order. The control group will receive placebo instead of Azithromycin