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Comparison of clinical course of the disease in patients with Covid-19 infection with or without antibiotics

Protocol summary

Study aim
Determining the clinical course of the disease in patients with Covid-19 infection with or without antibiotics
Design
A clinical trial with a control group, with parallel groups, three-way blind, randomized with random allocation software, was performed on 90 patients.
Settings and conduct
The study is performed on patients admitted to Hajar Hospital in Shahrekord with Covid disease and patients are divided into control and intervention groups. First, the clinical signs of Arterial oxygen level (O2Sat), temperature, respiratory rate and ESR, CRP, Ferritin and procalcitonin (PCT) tests are recorded from both groups of patients. Patients with a positive PCT test need to start antibiotics and do not enter the study. Patients in the control group receive the Remdesivir drug regimen and in the intervention group receive the Remdesivir and antibiotics. Antibiotics are cephalosporins and fluoroquinolones. ESR, CRP, Ferritin tests, fever, respiration rate, and oxygen saturation are checked one week later, and clinical signs, including fever, respiration rate, and oxygen saturation, are checked two weeks later.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients with confirmed molecular test (PCR positive); Blood oxygen saturation level SpO2 <93% in room air; Patients with moderate pulmonary involvement in radiological studies; No need for antibiotics in terms of indicator bacterial infection (PCT negative) Criteria for not entering: Patient dissatisfaction with participation in the study; Need for antibiotics in terms of bacterial infection index (PCT positive)
Intervention groups
In the control group, Remdesivir and in the intervention group, in addition to Remdesivir, antibiotics are used.
Main outcome variables
main outcome variables include: ESR; CRP; Ferritin; PCT (procalcitonin test); Arterial oxygen saturation (O2Sat); Temperature (T); Respiratory rate (RR)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210510051248N1
Registration date: 2022-01-22, 1400/11/02
Registration timing: registered_while_recruiting

Last update: 2022-01-22, 1400/11/02
Update count: 0
Registration date
2022-01-22, 1400/11/02
Registrant information
Name
Hamid Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 3121
Email address
st-mohammadi.h@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical course of the disease in patients with Covid-19 infection with or without antibiotics
Public title
Comparison of clinical course of the disease in patients with Covid-19 infection with or without antibiotics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with confirmed molecular test (PCR positive) Blood oxygen saturation level SpO2 <93% in room air Patients with moderate pulmonary involvement in radiological studies No need for antibiotics in terms of indicator bacterial infection (PCT negative)
Exclusion criteria:
Patient dissatisfaction with participation in the study Need for antibiotics according to the indication of bacterial infection (PCT positive)
Age
From 18 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomized using random allocation software. In the software, the number of groups and the number of samples and groups are determined. Numbers 1 to 90 are then randomly assigned to the control group and the intervention group. Control group : A Intervention group : B
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants will be divided into control groups (A) and intervention (B) using random allocation software. Envelopes are then prepared according to the number of people participating in the study, and numbers 1 to 90 are written on the envelopes and placed in each envelope using software A and B. In this way, with the arrival of each person, an envelope dedicated to that person is opened and according to the option inside the envelope, the person is assigned to one of the intervention or control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهش دانشگاه علوم پزشکی شهرکرد
Street address
خیابان کاشانی دانشگاه علوم پزشکی شهرکرد
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2021-11-16, 1400/08/25
Ethics committee reference number
IR.SKUMS.REC.1400.181

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Erythrocyte Sedimentation rate
Timepoint
Measurement of erythrocyte sedimentation rate on the first and seventh days
Method of measurement
Measurement of erythrocyte sedimentation rate by the device ESR analyzer semimex

2

Description
C-reactive protein
Timepoint
Measurement of C-reactive protein on the first and seventh days
Method of measurement
Measurement of C-reactive protein with the device BT-3500 And BT-3000

3

Description
ferritin
Timepoint
Measurement of ferritin on the first and seventh day
Method of measurement
Measurement of ferritin with the device Cobas

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Vial Remdesivir 100 mg Ronak Pharmaceutical Company for 5 days, 200 mg on the first day and 100 mg on the second to fifth days; Levofloxacin 750 mg tablets Abidi Pharmaceutical Company for 5 days, 750 mg daily; Vial Ceftriaxone 1 gr Exir Pharmaceutical for 5 days, 1 gr every 12 hours;
Category
Treatment - Drugs

2

Description
Control group: Vial Remdesivir 100 mg Ronak Pharmaceutical Company for 5 days, the first day 200 mg and the second to fifth days 100 mg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital in Shahrekord
Full name of responsible person
Ahmad Raesi
Street address
Hajar Hospital, Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Fax
+98 38 3224 3715
Email
Hajar-Hospital@skums.ac.ir
Web page address
https://hajarhp.skums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Kashani St. Headquarters of Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Web page address
https://research.skums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ahmad Raesi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital, Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
raesi.a@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ahmad Raesi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital, Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
raesi.a@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Hajar Hospital, Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817963946
Phone
+98 38 3222 0016
Email
Mohammadi_h1385@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Information about the main outcome can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Dr. ahmad raisi
Under which criteria data/document could be used
The documents can be used after printing the results
From where data/document is obtainable
The data can be used by referring to the e-mail address
What processes are involved for a request to access data/document
Access period starts 6 months after the trsults are published
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