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The effectiveness of dietary supplements containing antioxidant compounds on survival rate of patients with COVID-19

Protocol summary

Study aim
Evaluation of the effectiveness of the new formulation of antioxidant dietary supplement on the outcome (duration of discharge and death) of COVID-19 patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 50 patients. Balance block randomization method was used for randomization.
Settings and conduct
This study will be performed in two groups of patients (non-critical :) with Covid-19 disease (group receiving complementary therapy and receiving placebo) in Bu Ali Hospital (special isolation ward and corona emergency department that are in accordance with the treatment protocol). Took.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Positive coronavirus pharyngeal PCR test, involvement in CT lung scan. Oxygen level, sub-cough symptoms, sore throat, headache, nasal congestion, fever, body aches and pains, fatigue Exclusion criteria: Bacterial respiratory infections, serious chronic diseases, pregnant women with HIV, cancer, vascular disease, or endocrine disease that have required dose adjustment in the past 30 days. Also patients who become infected while studying.
Intervention groups
1- Placebo receiving group 2- Antioxidant supplement therapy group: (Formulation containing melatonin, acetylcysteine, vitamin C, vitamin E, glutathione, selenium and zinc)
Main outcome variables
Vital respiratory symptoms of patients, hours with fever as well as fibrinogen and di-dimer levels, ROS as well as laboratory indicators, corona virus loading rate, duration of possible need for use of mechanical lung ventilation systems, survival rate (duration of discharge and death, and 28-day death) patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160625028622N2
Registration date: 2022-01-16, 1400/10/26
Registration timing: prospective

Last update: 2022-01-16, 1400/10/26
Update count: 0
Registration date
2022-01-16, 1400/10/26
Registrant information
Name
Ehsan Aali
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
e.aali@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2022-06-19, 1401/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of dietary supplements containing antioxidant compounds on survival rate of patients with COVID-19
Public title
survey on the effect of antioxidant supplement on improvement of different symptom in covid-19 patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A positive PCR test for a new coronavirus Having an involvement in a CT scan of the lungs and a definitive diagnosis by the treating physician that the person is infected Therefore, people whose confirmed results of this virus are confirmed and who have 2 or more of the following symptoms will be studied in the following study: Including: Patients with pulmonary involvement of 50% and above (severe cases) (sometimes closed At the discretion of the physician and the patient's condition, lower lung involvement is also a criterion for hospitalization (moderate cases), 90 <O2 saturation <94 (moderate to severe cases) and o2 saturation <90 (severe cases), sub-cough symptoms (visual assessment criteria) Sore throat (patient report), headache (patient report), nasal congestion (patient report), fever (temperature above 37.3), body aches and pains (patient report), fatigue (patient report)
Exclusion criteria:
Patients suspected of having a bacterial respiratory infection at the beginning of the study Patients with serious chronic diseases. Pregnant women Patients with HIV Patients with cancer Patients with vascular disease Patient with endocrine disease Patients who become infected during studying
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two treatment groups A and B using the balance block method (Balance block randomization), the size of each block is 10 and the total number of blocks is 5 as described in the attached table. block identifier block size sequence within block treatment 1 10 1 Group B 1 10 2 Group B 1 10 3 Group B 1 10 4 Group B 1 10 5 Group A 1 10 6 Group A 1 10 7 Group A 1 10 8 Group A 1 10 9 Group A 1 10 10 Group B 2 10 1 Group B 2 10 2 Group A 2 10 3 Group A 2 10 4 Group A 2 10 5 Group B 2 10 6 Group A 2 10 7 Group B 2 10 8 Group A 2 10 9 Group B 2 10 10 Group B 3 10 1 Group A 3 10 2 Group A 3 10 3 Group B 3 10 4 Group B 3 10 5 Group A 3 10 6 Group A 3 10 7 Group A 3 10 8 Group B 3 10 9 Group B 3 10 10 Group B 4 10 1 Group A 4 10 2 Group A 4 10 3 Group A 4 10 4 Group B 4 10 5 Group B 4 10 6 Group A 4 10 7 Group B 4 10 8 Group A 4 10 9 Group B 4 10 10 Group B 5 10 1 Group B 5 10 2 Group B 5 10 3 Group B 5 10 4 Group A 5 10 5 Group A 5 10 6 Group A 5 10 7 Group B 5 10 8 Group B 5 10 9 Group A 5 10 10 Group A
Blinding (investigator's opinion)
Double blinded
Blinding description
Complementary therapy and placebo are delivered to the hospital doctor in two cans of medicine with different codes. The doctor does not know the contents of these cans and only based on the defined codes, the researcher informed them.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ًQazvin University of Medical Sciences
Street address
Bahonar street, qazvin university of medical science
City
qazvin
Postal code
3419759811
Approval date
2021-12-18, 1400/09/27
Ethics committee reference number
IR.QUMS.REC.1400.365

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
Cough
Timepoint
At the beginning of the study, 14 and 28 days
Method of measurement
frequency and severity

2

Description
chest pain
Timepoint
At the beginning of the study, 14 days
Method of measurement
presence or absence

3

Description
shortness of breath
Timepoint
At the beginning of the study, 14 days
Method of measurement
presence or absence

4

Description
O2 saturation level
Timepoint
At the beginning of the study, 14 days
Method of measurement
Oxygen level (O2 Saturation) with device

5

Description
number of days with tachypnea
Timepoint
At the beginning of the study, 14 days
Method of measurement
Breathe more than 12-20 times a minute

6

Description
fever
Timepoint
At the beginning of the study, 14 days
Method of measurement
Temperatures above 37.3, with an accuracy of 6 hours

7

Description
fibrinogen levels
Timepoint
At the beginning of the study, 14 days
Method of measurement
Diagnostic laboratory

8

Description
di-dimer
Timepoint
At the beginning of the study, 14 days
Method of measurement
Diagnostic laboratory

9

Description
ROS
Timepoint
At the beginning of the study, 14 days
Method of measurement
Diagnostic laboratory

10

Description
laboratory indicators
Timepoint
At the beginning of the study, 14 days
Method of measurement
Diagnostic laboratory

11

Description
duration of possible need for use of mechanical lung ventilation systems
Timepoint
At the beginning of the study, 14 days
Method of measurement
Duration of possible need for use of mechanical lung ventilation systems

12

Description
survival rate of patients
Timepoint
At the beginning of the study, 14 and 28 days
Method of measurement
Duration of clearance and mortality 28 days

Secondary outcomes

empty

Intervention groups

1

Description
Antioxidant supplement,Antioxidant supplement, this study is a clinical trial study. Initially, capsules containing defined doses of antioxidant compounds are formulated with the formulation and based on related studies in a pharmaceutical laboratory located in Tehran province, a pharmacologist prepares, manufactures and quality controls. This capsule contains 250 mg of vitamin C, 300 mg of N-acetylcysteine, 2.5 mg of melatonin, 100 mg of selenium, 200 mg of glutathione and 60 mg of vitamin E and 5 mg of zinc. These supplements are purchased commercially from reputable companies active in this field in higher quantities by calculating the required amount according to their defined formulation and taking into account the number of patients, and the capsules are prepared, packaged and prepared in the pharmaceutical company. Target groups will receive two supplements / placebo on the first day and one every day for 10 days in the coming days. First, the informed consent form will be delivered to all patients and written consent will be obtained from them.
Category
Treatment - Drugs

2

Description
Placebo,Placebo, this group of patients with Covid 19 (Non-Critical) who will receive routine drugs of the country's treatment protocol and will receive two placebo on the first day and one every day for 10 days in the coming days. Patients will be imaged before treatment begins.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Buali hospital of Qazvin
Full name of responsible person
Dr Saeed farzam
Street address
Naderi Street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 9049
Email
boali.hospital@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
Info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Ehsan Aali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Bahonar Street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
en.aali@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Abbas Alami
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Fax
+98 28 3332 4970
Email
allami9@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sanaz Keshavarz Shahbaz
Position
Reseracher
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Fax
+98 28 3332 4970
Email
Sanaz.ks_023@yahoo.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
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