Evaluation of the effectiveness of Spirulina extract (Arthospira) on the improvement of clinical and laboratory symptoms in patients with Covid-19: Clinical Trial
Evaluation of the effectiveness of Spirulina extract (Arthospira) on the improvement of clinical and laboratory symptoms in patients with Covid-19: Clinical trial
Design
The clinical trial has two groups of 105 controls and the intervention is performed by simple double-blind randomization. Randomization using computer software is performed by a person other than the study researchers and based on the number assigned to each patient.
Settings and conduct
In Razi Hospital, Ahvaz, two groups of Covid-19 patients, 105 people each, one group receiving standard treatments and the other group receiving spirulina extract in addition to standard treatments. A double-blind study evaluating the outcome and analyzing the data does not have basic information about who is in the control group and who is in the main group and receiving the extract.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive confirmation of Covid 19 based on PCR results and approved global health clinical signs confirmed by a specialist; They are hospitalized. Patients have informed consent to enter the study.
Exclusion criteria: the physician's decision not to participate in the study, the patient to be present in another clinical trial.
Intervention groups
Control group: There are patients who receive standard treatment for COVID-19 (oseltamivir, hydroxychloroquine, and lopinavir) according to the protocol of the Ministry of Health.
Intervention group: There are patients who, in addition to standard treatment, receive spirulina extract at a dose of 5 mg twice a day (every 12 hours) for seven days. Spirulina microalgae are prepared from Qeshm Microalgae Biore Refinery Company and extracted in Alborz Cell Fan Accelerator.
Evaluation of the effectiveness of Spirulina extract (Arthospira) on the improvement of clinical and laboratory symptoms in patients with Covid-19: Clinical Trial
Public title
Evaluation of the effect of spirulina extract on patients with coronavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive confirmation of Covid 19 based on PCR results and approved global health clinical signs confirmed by a specialist; They are hospitalized.
Patients have informed consent to enter the study.
Exclusion criteria:
The physician's decision not to participate in the study.
The patient to be present in another clinical trial.
Age
From 18 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Using computer software with a simple randomization method by a person who is not a researcher and based on the number assigned to each patient are divided into two groups of intervention and control.le randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome Evaluator and Data Analyzer Do not have basic information about who is in the control group and who is in the main group and the recipient of the extract.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Olum pezeshki Blvd, Ahvaz, Khuzestan Province
City
Ahvaz
Province
Khouzestan
Postal code
15794 61357
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.AJUMS.REC.1399.970
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19 infection
Primary outcomes
1
Description
fever
Timepoint
Daily monitoring from the beginning of the intervention to the end
Method of measurement
Thermometer
2
Description
Oxygen saturation
Timepoint
Daily monitoring from the beginning of the intervention to the end
Method of measurement
Pulse oximeter
3
Description
dry cough
Timepoint
Daily monitoring from the beginning of the intervention to the end
Method of measurement
Physical examination,questionnaire
4
Description
C-reactive protein (CRP)
Timepoint
The first day and the 7th day
Method of measurement
Blood sampling- ELISA
5
Description
Interleukin 6 (IL-6)
Timepoint
The first day and the 7th day
Method of measurement
Blood Sample method: ELISA ; sensivity 0.06 pg/ml
Secondary outcomes
1
Description
Duration of Stay in ICU
Timepoint
Since the first day till end of stay in ICU
Method of measurement
Observation
Intervention groups
1
Description
Control group: There are patients who receive standard treatment for COVID-19 (oseltamivir, hydroxychloroquine and lopinavir) according to the protocol of the Ministry of Health.
Category
Treatment - Drugs
2
Description
Intervention group: There are patients who, in addition to standard treatment, receive spirulina extract at a dose of 5 mg twice a day (every 12 hours) for seven days. Spirulina microalgae are prepared from Qeshm Microalgae Biore Refinery Company and extracted in Alborz Cell Fan Accelerator.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital of Ahvaz
Full name of responsible person
Dr. Farid Yosefi
Street address
Palestine St., in front of the governorate, Razi Hospital of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 5935
Email
drfayo@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mahdi Ahmadi moghadam
Street address
Ahvaz Jondishapur University of Medical Sciences,Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Ahmadi-m@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
2
Sponsor
Name of organization / entity
Paya Fan Yakht Alborz Company
Full name of responsible person
Dr.Hooman Kaghazian
Street address
No. 12, Unit 2, Corner of Shahid Arab Najafi Alley, in front of Tehran Villa Three Ways, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1455844816
Phone
+98 21 6653 0487
Email
kaghazian@pasteur.ac.ir
Web page address
https://celltechco.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Paya Fan Yakht Alborz Company
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
Hakhamanesh Biotechnology
Full name of responsible person
Seyed Shahab Atashi
Position
Chairman of the Board
Latest degree
Master
Other areas of specialty/work
Medical Biotechnology
Street address
No. 12, Unit 2, Corner of Shahid Arab Najafi Alley, in front of Tehran Villa Three Ways, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1455844816
Phone
+98 21 6653 0487
Email
seyedshahabatashi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Mard
Position
full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Golestan Hiway, Ahvaz Jondishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 6104
Email
Alimard77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hkhamanesh biotechnology company
Full name of responsible person
Parya Alidadiani
Position
vice chairman
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
No. 12, Unit 2, Corner of Shahid Arab Najafi Alley, in front of Tehran Villa Three Ways, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1455844816
Phone
+98 21 6653 0487
Email
Alidadp2@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