Evaluating the Safety and Effectiveness of Septimeb in Patients with COVID-19 Referred to Selected Hospitals of Tehran University of Medical Sciences: A Clinical Trial Study (Phase III)
valuating the Safety and Effectiveness of Septimeb in Patients with COVID-19
Design
Clinical trial with control group, without blinding, randomized by simple randomization on 240 patients
Settings and conduct
Patients admitted to Imam Khomeini, Shariati, Amir-E-Alam and Ziaian hospitals who meet the inclusion criteria will be treated with Septimeb for a minimum of seven days and a maximum of 14 days in addition to the national protocol. People in the control group are treated only according to the national protocol. There is no blindness in this study and patients are aware of which group (control or intervention) they are in.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
18 years old, having positive PCR test, fever, dry cough, shortness of breath, CT scan with at least 40% lung involvement, presence of myocarditis, sepsis, ARDS, cytokine storm, increased ESR, increased LDH and increased D-DIMER test
Exclusion Criteria:
No COVID-19 PCR test
Drug users - Alcohol consumers and Immune suppressive drug users
People undergoing chemotherapy
Consumers of growth medications, testosterone and anabolic steroids
Patients during pregnancy and breastfeeding
Intervention groups
Control group: treatment according to national protocol (including corticosteroids)
Intervention group: Septimeb treatment + national protocol treatment (including corticosteroids)
Main outcome variables
Patients' Mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100601004076N27
Registration date:2022-01-02, 1400/10/12
Registration timing:prospective
Last update:2022-01-02, 1400/10/12
Update count:0
Registration date
2022-01-02, 1400/10/12
Registrant information
Name
Minoo Mohraz
Name of organization / entity
Iranian Research Center for HIV/AIDS, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 7984
Email address
minoomohraz@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Safety and Effectiveness of Septimeb in Patients with COVID-19 Referred to Selected Hospitals of Tehran University of Medical Sciences: A Clinical Trial Study (Phase III)
Public title
Evaluating the Safety and Effectiveness of Septimeb in Patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed and voluntary oral and written consent of the patient or his / her guardian to participate in the study
Age over 18 years
SARS-CoV-2 virus PCR test positive or having one of the following conditions: Strong symptoms of COVID-19 disease, including fever, dry cough, and shortness of breath
CT scan (HRCT or Spiral CT) that shows involvement with Cornavirus (at least 40% of lung involvement), especially ground glass in the peripheral or base of the lungs
Patients suffering from life-threatening complications due to COVID-19 disease including ARDS, myocarditis, sepsis, cytokine storm (with ESR above 100 or platelet decline over 3 days or elevated D-Dimer above normal or LDH above normal).
Exclusion criteria:
Individuals whose Covid-19 test has not been approved
Individuals who use drugs
Individuals who drink alcohol
Individuals who use immunosuppressive drugs
Individuals under chemotherapy or radiotherapy
Individuals who use growth hormone, testosterone and anabolic steroids
The patient is pregnant or breastfeeding.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method is used. Random number table is a set of numbers that are generated completely randomly and are tabulated. Firstly, we determine the direction of the random number table and then we decide to read the random number table from above. Then we consider even numbers for the intervention group and odd numbers for the control group. We assign 240 codes from 1 to 240 to the patients hospitalized to the ward. Then we put patients with even code in the intervention group and patients with odd code in the control group. Thus, a total of 240 people will be assigned to the intervention and control groups.
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
Iranin Research Center for HIV/AIDS, Qarib street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2021-12-12, 1400/09/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1052
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Morbidity
Timepoint
At the time of hospitalization, every 3 days until the day of discharge from the hospital
Method of measurement
Vital Signs Examination
Secondary outcomes
1
Description
Fever
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
2
Description
Headache
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
3
Description
Nausea
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
4
Description
Shivering
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
5
Description
Rhinitis
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
6
Description
Dry Cough
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
7
Description
Myalgia
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
8
Description
Diarrhea
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
9
Description
Shortness of breath
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
10
Description
Weakness and lethargy
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
11
Description
Blood Pressure
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
12
Description
O2 saturation rate
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Clinical Examination
13
Description
Complete blood count and differentiation
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Laboratory Test
14
Description
C-reactive Protein
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Laboratory Test
15
Description
Erythrocyte sedimentation rate (ESR)
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Laboratory Test
16
Description
Alanine Aminotransferease (ALT)
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Laboratory Test
17
Description
Aspartate aminotransferase (AST)
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Laboratory Test
18
Description
Creatinine Test
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Laboratory Test
19
Description
Di-Dimer Test
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Laboratory test
20
Description
Presence of ground-glass appearance
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Chest X-ray
21
Description
Alveolar Complication
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Chest X-ray
22
Description
Unilateral or bilateral pulmonary involvement
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Chest X-ray
23
Description
Location of Involvement
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Chest X-ray
24
Description
Presence of Acute respiratory distress syndrome (ARDS)
Timepoint
At the time of hospitalization, every three days until respiratory conditions stabilize, at the time of discharge
Method of measurement
Chest X-ray
Intervention groups
1
Description
Intervention group: Patients will receive 10 ml (150 mg) of Septimib at the first day and 20 ml (30 mg) from the second day (minimum for one week and maximum for two weeks) in addition to national protocol treatments (including corticosteroids).
Category
Treatment - Drugs
2
Description
Control group: Treatment based on National Protocol
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Mohammad Reza Salehi
Street address
Imam Khomeini hospital, Dr. Qarib st., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1583
Email
Imamhospital@tums.ac.ir
2
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Naser Aghdam
Street address
Jalale-Ale-Ahmad Ave, North Karegar Ave.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
3
Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Saeid Reza Jamali Moghaddam
Street address
Qazvin street, Qapan crossroads
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6810
Email
ziaeian@tums.ac.ir
4
Recruitment center
Name of recruitment center
Amir A'lam Hospital
Full name of responsible person
Alo Asadollahi Amin
Street address
North Sa'di St., Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 6106
Email
hamiralam@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Vice Chancellor of Research, Tehran University of Medical Sciences, Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khorram Khorshid
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2000
Email
hrkhkh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
SeyedAhmad SeyedAlinaghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
End of Keshavar Blvd., Imam Khomeini Hospital Complex, Basement of the Infection department (Building 6), Iranian Research Center for HIV/AIDS
City
Tehran
Province
Tehran
Postal code
1146546884
Phone
+98 21 6658 1583
Fax
+98 21 6694 7984
Email
s_a_alinaghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Salar Pashangzadeh
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
End of Keshavar Blvd., Imam Khomeini Hospital Complex, Basement of the Infection department (Building 6), Iranian Research Center for HIV/AIDS
City
Tehran
Province
Tehran
Postal code
1146546884
Phone
+98 21 6658 1583
Email
salar71000@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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