The effect of microalga Spirulina platensis supplement on the recovery of patients with coronavirus hospitalized in the coronavirus ward and reduction of mortality due to the disease.
The effect of spirulina platensis supplementation on disease severity and mortality in patients with coronavirus.
Design
The clinical trial has a control group and parallel intervention, one-sided blind, random, phase 3 on 60 patients. for randomization, we used the table of random numbers.
Settings and conduct
The present study is a single-blind clinical trial study (The patient is unaware of the intervention and the treatment staff is aware of the intervention) and The target population of this study is patients with coronavirus hospitalized in the coronavirus ward of Ziaeian Hospital and Baharloo Hospital.
Participants/Inclusion and exclusion criteria
Patients with coronavirus.
Inclusion criteria
1- Male and female patients more than 18 and less than 65.
2- The patient is stable in condition and does not need resuscitation.
3- Signed informed consent form.
4- Definitive/clinical diagnosis of coronavirus.
...
Exclusion criteria
1- Pregnancy or lactation.
2- Any history of drug allergy.
3- Active, clinically significant chronic illness or human immunodeficiency virus disease.
4- Significant organ dysfunctions such as renal failure, liver dysfunction, CHF, or serious and unstable cardiac condition.
...
Intervention groups
Patients who are eligible for inclusion based on the inclusion criteria, randomly using the block randomization method, are divided into two groups based on gender: intervention and placebo. After obtaining the consent of patients for supplementation, the intervention group will be supplemented daily with 15 g of dry powder of Spirulina platensis algae. The placebo used in this study will be similar to the supplement used in the intervention group in terms of shape and smell.
Main outcome variables
Reducing the severity of the disease and its mortality.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050373N1
Registration date:2021-05-28, 1400/03/07
Registration timing:registered_while_recruiting
Last update:2021-05-28, 1400/03/07
Update count:1
Registration date
2021-05-28, 1400/03/07
Registrant information
Name
Seyed ahmad Seyed alinaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1583
Email address
s_a_alinaghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-03, 1399/12/13
Expected recruitment end date
2022-03-04, 1400/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of microalga Spirulina platensis supplement on the recovery of patients with coronavirus hospitalized in the coronavirus ward and reduction of mortality due to the disease.
Public title
The effect of Spirulina platensis supplement in the treatment of coronavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female patients more than 18 and less than 65.
The patient is stable in condition and does not need resuscitation.
Signed informed consent form.
Definitive/clinical diagnosis of coronavirus.
Body mass: 18.5 - 30.
The same treatment protocol (coronavirus) in both groups.
Moderate severity of the disease.
Exclusion criteria:
Pregnancy or lactation.
Any history of drug allergy.
Active, clinically significant chronic illness or human immunodeficiency virus disease.
Significant organ dysfunctions such as renal failure, liver dysfunction, CHF, or serious and unstable cardiac condition.
Underlying conditions that can affect patients' ability to provide adequate data.
Inability or refusal to sign the informed consent.
Any concurrent diseases or conditions which delay wound healing (cancer, vasculitis, immunosuppressive disorders, etc.)
Treatment with corticosteroids, Treatment with blood thinners, immunosuppressants, radiotherapy, or chemotherapy.
Receiving any investigational drug within 30 days prior to screening.
Abnormal liver enzymes and total bilirubin > 1.5 times of normal upper limit.
Specific and rare diseases such as people with HIV who are not receiving antiretroviral treatment, multiple sclerosis, SLE, rheumatoid arthritis, and PKU.
Observation of clinical signs not previously seen in patients with coronavirus and unusual complaints from patients.
Severe nausea after taking medication that does not improve with routine supportive treatment is considered as an exclusion criterion.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
3
Each patient will be sampled three times. On the first day, the third day, and the fifth day
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the patient's hospitalization before the start of the study, demographic information from patients is recorded, information related to the history of specific diseases and related to anthropometrics and current disease conditions. Patients who are eligible for inclusion based on the inclusion criteria, randomly with the block randomization method that will maintain balance in the two groups are placed in two groups of intervention and placebo. Using a random block table for patients makes the randomization action equal in the two groups in total. Also, using a random block table causes patients to be equally assigned to both groups at each stage of the study. These small blocks maintain a balance between the two groups and make the number of people in each group similar. In our study, considering that there are two groups, 4 patients are considered for each block.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is a single-blind clinical trial study so that the patient is unaware of the intervention and the medical staff is aware of the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam khomeini Hospital Complex- Tehran University of Medical Sciences
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The research results will be presented and published only in the form of reports and articles.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers for use in articles and reports, especially systematic review articles.
From where data/document is obtainable
To receive the required documents or data, refer to the project manager, Dr. Seyed Ahmad Seyed Alinghi, at the Iranian Research Center for HIV/AIDS.
Phone number: 00982166581583
Email: s.a.alinaghi@gmail.com
Address: Iranian Research Center for HIV/AIDS, behind the Infectious Diseases Building, Imam Khomeini Hospital Complex, end of Keshavarz Boulevard, Tehran.
What processes are involved for a request to access data/document
After making the call(Phone, meet, Email) and providing the necessary documents(Written request), the documents or data files will reach the applicant.