Determining the Safety and Effectiveness of ENDOR Oral Combination Drug in the Treatment of Patients with Covid-19 Referred to Imam Khomeini Hospital in Tehran
Determination of Effectiveness and safety of Endor oral drug in patients diagnosed with COVID19
Design
Clinical trial with control group, single blind, randomized based on Simple Randomization on 200 patients
Settings and conduct
Patients hospitalized in Imam Khomeini Hospital who meet the inclusion criteria will be treated with Endor or placebo along with standard treatment according to national protocol for 7 days. This is the single blind study and Patients do not know which group (control or intervention) they are in.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
COVID-19 positive test
Confirmed CT scan
Over 18 years old
Individuals experienced Acute respiratory distress syndrome (ARDS) and Myocarditis
Exclusion Criteria:
Substance and alcohol consumers
Consumers of immunosuppressive drugs
People undergoing chemotherapy, radiotherapy and interferon
Consumers of growth hormone drugs, testosterone and anabolic steroids
Intervention groups
Control group: people taking placebo + treatment according to national protocol
Intervention group: People taking Endor + treatment according to national protocol
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
2021-11-22, 1400/09/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the Safety and Effectiveness of ENDOR Oral Combination Drug in the Treatment of Patients with Covid-19 Referred to Imam Khomeini Hospital in Tehran
Public title
Determining the Safety and Effectiveness of ENDOR Oral Combination Drug in the Treatment of 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
Existence of CT scan confirming lung involvement, especially ground glass view
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
200
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 200 codes from 1 to 200 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 200 people will be assigned to the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
For reducing the bias, single-blind method was taken into account. Placebo capsules were used to prevent patients from being informed about which group they are belonging to, Control or Intervention. Placebo capsules are designed to be similar in color and size to Endor capsules. In this study, patients will not be aware of which group they are in, the rest of the study members are aware of patients grouping.
Placebo
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
2021-09-19, 1400/06/28
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.676
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
Complete Blood Count (CBC), Differentiation
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Laboratory Tests
2
Description
Erythrocyte sedimentation rate (ESR)
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Laboratory Test
3
Description
C-Reactive Protein (CRP)
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Laboratory Test
4
Description
Alanine Aminotransferease (ALT)
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Laboratory Test
5
Description
Aspartate aminotransferase (AST)
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Laboratory Test
6
Description
Creatinine
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Laboratory Tests
7
Description
Di-Dimer Test
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Laboratory Tests
8
Description
Respiratory Presentations
Timepoint
During Hospitalization
Method of measurement
Clinical Examination
9
Description
Weakness and lethargy
Timepoint
During Hospitalizations
Method of measurement
Clinical Examinations
10
Description
Fever
Timepoint
During Hospitalization
Method of measurement
Clinical Presentations
11
Description
Myalgia
Timepoint
During Hospitalization
Method of measurement
Clinical Examinations
12
Description
Dry Cough
Timepoint
During Hospitalization
Method of measurement
Clinical Examinations
13
Description
Existence of sputum
Timepoint
During Hospitalization
Method of measurement
Clinical Examinations
14
Description
Sore throat
Timepoint
During Hospitalization
Method of measurement
Clinical Examinations
15
Description
Diarrhea
Timepoint
During Hospitalization
Method of measurement
Clinical Examinations
16
Description
Shortness of breath
Timepoint
During Hospitalization
Method of measurement
Clinical Examination
17
Description
Rhinitis
Timepoint
During Hospitalization
Method of measurement
Clinical Examinations
18
Description
Nausea
Timepoint
During Hospitalization
Method of measurement
Clinical Examinations
19
Description
Headache
Timepoint
During Hospitalization
Method of measurement
Clinical Examinations
20
Description
Shivering
Timepoint
During Hospitalization
Method of measurement
Clinical Examination
21
Description
Presence of ground-glass appearance
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Chest X-ray
22
Description
Alveolar Complication
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Chest X-ray
23
Description
Unilateral or bilateral pulmonary involvement
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Chest X-ray
24
Description
Location of Involvement
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Chest X-ray
25
Description
Presence of Acute respiratory distress syndrome (ARDS)
Timepoint
During Three days of Hospitalization and at the time of discharging
Method of measurement
Chest X-ray
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the intervention group, in addition to the standard treatment according to national protocol, consumes two oral capsules of Endor every eight hours for seven days. This capsule contains Betacarotene -2.5mg, Curcuma longa rhizome extract equiv. to dry- 1.25g, (Equiv. Curcumin- 23.75mg), Fish Oil – Rich in Omega 3 acids- 250mg, (Equiv. Docosahexaenoic acid [DHA]-30mg), ](Equiv. Eicosapentaenoic acid [EPA]- 45mg), (Equiv. Omega 3 marine triglycerides-75mg), Sodium ascorbate-56.8mg, (Equiv. Ascorbic acid [Vitamin C]-50mg ), Wheatgerm Oil – 75mg, Zinc Sulfate – 27.62mg, (Equiv. Zinc – 10mg). This capsule has been manufactured by Ghadiminezhad Daru
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
Minoo Mohraz
Street address
Imam Khomeini hospital, Dr Qarib st., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1583
Email
minoomohraz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghadiminezhad Daru
Full name of responsible person
Iraj Ghadiminejad
Street address
Department 7, First Floor, Jahan-E Felez Building, No. 7, Masjed-E Aqa Alley, Pamenar St, 15-E khodad St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1116844133
Phone
+98 21 2257 1372
Email
iraj@gnpau.com
Web page address
https://gnpau.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghadiminezhad Daru
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general 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
Clinical 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
1419733141
Phone
+98 21 6658 1583
Email
s_a_alinaghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Minoo Mohraz
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
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
۷۳۳۱۴۱-۱۹-۱۴
Phone
+98 21 6658 1583
Email
minoomohraz@ams.ac.ir
Web page address
https://ircha.tums.ac.ir/
Person responsible for updating data
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
Clinical 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
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