Determination of therapeutic effects of Metronidazole In Inpatients with Pneuomonia Due to COVID-19
Design
Clinical trial with control group, single-blind, randomized, phase 2 on 15 patients and will followe for 7 days.Inpatient admission dates will be used for randomization.
Settings and conduct
This pilot randomized single-blind clinical trial will be performed in shohada gomnam hospital on patients after obtaining permission from the ethics committee on patients with pneumonia caused by the COVOID-19 , who are on antiviral medication according to national protocol. Patients will be divided into two groups. intervention group will be treated with metronidazole 250 mg every 6 hours. Laboratory and clinical symptoms will be evaluated every 7 days. The data will be analyzed by SPSS software.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Hospitalized patients with COVOID-19 pneumonia
Covid 19 infection should be confirmed by RT-PCR or lung CT scan.
Both genders Age ≥18 years at time of signing Informed Consent Form Willing and able to provide written informed consent prior to performing study to any assigned treatment arm Must agree not to enroll in another study of an investigational agent prior to completion of study .
Exclusion criteria:
Known allergic reaction to metronidazole Pregnant or breastfeeding, or positive pregnancy test
Intervention groups
Patients with pneuomonia due to COVOID-19 will receive Standard of care treatment according to the national guidelines
intervention group will receive metronidazole 250 every 6 hours In addition to standard treatment and control group will not receive receive metronidazole.
Main outcome variables
O2 Saturation,
Lenght of hospitat stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047686N1
Registration date:2020-06-30, 1399/04/10
Registration timing:registered_while_recruiting
Last update:2020-06-30, 1399/04/10
Update count:0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Muhanna Kazempour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 7243
Email address
muhannakazempour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-31, 1399/03/11
Expected recruitment end date
2020-07-01, 1399/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effects of Metronidazole In Inpatients with Pneuomonia Due to COVID-19
Public title
The role of metronidazole in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inpatients with Pneuomonia Due to COVID-19
Exclusion criteria:
Hypersensitivity Reactions to Metronidazole
Pregnancy
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
After signing the consent form, According to the admission date of hospitalized patients with pneumonia due to COVID-19, Participants are randomly assigned to intervention or control groups and they are not aware of the group to which they are allocated.
Placebo
Not used
Assignment
Parallel
Other design features
According to the admission date of hospitalized patients with pneumonia due to COVID-19, Participants are randomly assigned to intervention or control groups and they are not aware of the group to which they are allocated.The "intervention group" receives national standard treatment in addition to metronidazole, and the "control group" receives standard treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Yaman St, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
19857-17443
Approval date
2020-05-30, 1399/03/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.157
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
O2 Saturation
Timepoint
within 7 days from initiation of study treatmentat
Method of measurement
Pulse Oximetry
Secondary outcomes
1
Description
Lenght of hospitat stay
Timepoint
daily up to discharge
Method of measurement
Inpatient days
2
Description
Mortality
Timepoint
daily up to death during hospitalizatiion
Method of measurement
Patient death
Intervention groups
1
Description
Intervention group: 15 eligible patients with moderate to severe COVID-19 in a 1:1 ratio compared to the control group who receive 250 mg metronidazole tablets orally every 6 hours for 7 days in addition to the standard treatment.
Category
Treatment - Drugs
2
Description
Control group: 15 eligible patients with moderate to severe COVID-19 disease who receive national standard treatment for COVID-19.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Gomnam Hospital
Full name of responsible person
Muhanna Kazempour
Street address
Shahid Mohammad Reza Azam Erfani St, Khorasan Square
City
Tehran
Province
Tehran
Postal code
1794694616
Phone
+98 21 3631 2001
Email
shgm-hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Yaman St, Velenjak St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Muhanna Kazempour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Loghman Hakim Hospital, Kamali Ave, South Kargar St
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
muhannakazempour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Muhanna Kazempour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Loghman Hakim Hospital, Kamali Street, South Karegar Avenue
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 7243
Email
muhannakazempour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Muhanna Kazempour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Loghman Hakim Hospital, Kamali Street, South Karegar Avenue
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 7243
Email
muhannakazempour@gmail.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
At the time of publication
When the data will become available and for how long
At the time of publication
To whom data/document is available
Public
Under which criteria data/document could be used
They will be publically available.
From where data/document is obtainable
The study protocol, statistical analytic plan informed consent forms will be shared as supplementary material at the time of publication of results.
What processes are involved for a request to access data/document
The study protocol, statistical analytic plan informed consent forms will be shared as supplementary material at the time of publication of results.