To determine the efficacy and safety of azithromycin in treatment of patients with confirmed covid-19 infection in zeiaeian Hospital, Tehran
Design
Two arm parallel group randomised trial and open lable .
Settings and conduct
The place of work is Ziaian Hospital in Tehran and all eligible patients will be thoroughly informed about the trial and sign an informed consent form; after which they will be randomly put in the two study arms. Patients in each arm of the study will receive a 5-day course of treatment of the mentioned drugs; and the results of their treatments will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Obtaining informed consent from patient or patient’s legal proxy .over 18 years of age .A documented positive PCR test for SARS-CoV-2 or one of the :
Compelling clinical symptoms including: fever, dry cough and dyspnea ,A typically involvement of lungs in HRCT or Spiral CT scanning that attributed to a covid-19 pneumonia . pregnant Patients. a known allergy to chloroquine or hydroxylchloroquinePatients with retinopathy, G6PD deficiency and a prolonged QT interval
Intervention groups
Case group: These patients receive daily azithromycin 500 mg, bi-daily oseltamivir 75, bi-daily lopinavir/ritonavir or in case of adverse gastrointestinal effects daily atazanavir (Kaletra) 400/100 mg and daily 400 mg of hydroxychloroquine; all for 5 days.Control group: These patients receive bi-daily oseltamivir 75, bi-daily lopinavir/ritonavir or atazanavir (Kaletra) 400/100 mg and in case of adverse gasterointestinal effects, daily atazanavir (Kaletra) 400/100 mg and daily 400 mg of hydroxychloroquine; all drugs are administered for five days.
Main outcome variables
fever
respiratory rate
admission duration
need an ICU
spo2
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200415047092N1
Registration date:2020-04-20, 1399/02/01
Registration timing:prospective
Last update:2020-04-20, 1399/02/01
Update count:0
Registration date
2020-04-20, 1399/02/01
Registrant information
Name
ehsan sekhavati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 9613
Email address
dr.esekhavati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-24, 1399/02/05
Expected recruitment end date
2020-05-08, 1399/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and Effectiveness of azithromycin in Patients with COVID-19 Referred to zeiaeian Hospital : A clinical trial study
Public title
The effect of azithromycin in treatment of COVID19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Obtaining informed consent from patient or patient’s legal proxy for inclusion in this study.-
Patients must be over 18 years of age-
A documented positive PCR test for SARS-CoV-2 or one of the following criteria:1. Compelling clinical symptoms associated with a covid-19 infection; including: fever, dry cough and dyspnea2. A typically involvement of lungs observed in HRCT or Spiral CT scanning that can be strongly attributed to a covid-19 pneumonia3.
Patients that have developed known complications of a covid-19 infection such as acute respiratory distress syndrome (ARDS) or myocarditis.
Exclusion criteria:
pregnancy or nursing
Patients whose covid-10 infection has not been proven and have symptoms that can be attributed to either the common cold or influenza and/or have had a positive PCR test for influenza.
known allergy to chloroquine or hydroxylchloroquine
retinopathy
G6PD deficiency
prolonged QT interval
severe heart failure
Pacemaker implantation
cardiac arrhythmia
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients use randomized block-chain, which not only makes Randomization equal in two groups, but also allows patients to be assigned equally to both groups at each stage of the study. These small blocks keep the balance between the two groups and make the number of people in each group similar. In our study, considering that there are two groups, four patients are considered for each block.
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
Ethics committee of Tehran University of Medical Sciences
Street address
zeiaeian hospital, abuzar ave.
City
tehran
Province
Tehran
Postal code
1366736511
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.TUMS.VCR.REC.1399.165
Health conditions studied
1
Description of health condition studied
SARS-COV2 ASSOCIATED INFECTION
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
peripheral capillary oxygen saturation
Timepoint
At the beginning of the visit and daily during admission
Method of measurement
pulse oximeter
2
Description
Admission duration
Timepoint
From the beginning of the hospital visit to the discharge
Method of measurement
Questionnaire
3
Description
Fever
Timepoint
At the beginning of the visit and daily during admission
Method of measurement
Mercury thermometer
4
Description
Need to ICU admission
Timepoint
During admission
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: These patients receive daily azithromycin 500 mg, bi-daily oseltamivir 75, bi-daily lopinavir/ritonavir or in case of adverse gastrointestinal effects daily atazanavir (Kaletra) 400/100 mg and daily 400 mg of hydroxychloroquine; all for 5 days.
Category
Treatment - Drugs
2
Description
Control group: These patients receive bi-daily oseltamivir 75, bi-daily lopinavir/ritonavir or atazanavir (Kaletra) 400/100 mg and in case of adverse gasterointestinal effects, daily atazanavir (Kaletra) 400/100 mg and daily 400 mg of hydroxychloroquine; all drugs are administered for five days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zeiaeian hospital
Full name of responsible person
Ehsan Sekhavati Moghadam
Street address
Zeiaeian hospital ,Abuzar Ave,Tehran
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6810
Email
Dr.esekhavati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Research Departmet of Tehran University Medical Science ,Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 8163 3698
Email
Vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Sekhavati Moghadam
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Zeiaeian hospital , Abuzar Ave
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6810
Email
Dr.esekhavati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fereshte Ghiasvand
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Imam Khomeyni hospital , Dr Gharib Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
02161190
Email
Ghiasvand_62@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fereshte Ghiasvand
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Imam Khomeyni hospital , Dr Gharib Ave
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
02161190
Email
Ghiasvand_62@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A part of the data, such as information about the main consequence or similar, can be shared.
When the data will become available and for how long
Start of access from 1399
To whom data/document is available
Researchers working in academic and scientific institutions, people who are also engaged in industry
Under which criteria data/document could be used
Mentioning the source and Permission and consultation with the responsible author are mandatory
From where data/document is obtainable
EMAIL
DR.FERESHTEGHIASVAND
What processes are involved for a request to access data/document
Send emails and mention the required files and the reason for the request and description of using the data