Protocol summary
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Study aim
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The effect of spirulina platensis supplementation on disease severity and mortality in patients with coronavirus.
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Design
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This clinical trial has parallel intervention and control group, open-label, randomized, multicenter, phase 3 on 240 patients. Random Allocation Software was used for randomization.
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Settings and conduct
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The present study is an open-label clinical trial. The target population is patients hospitalized in the coronavirus ward of Ziaeian Hospital and Baharloo Hospital.
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Participants/Inclusion and exclusion criteria
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Patients with coronavirus.
Inclusion criteria
1- Male and female patients, age ≥18.
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.
...
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Intervention groups
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Based on the entry criteria, patients who are eligible to enter the study are randomly divided into two intervention and control groups using the block randomization method. After obtaining consent from the patients, the intervention group will receive 15/2 g spirulina platensis algae powder daily.
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Main outcome variables
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Reducing the severity of the disease and its mortality.
General information
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Reason for update
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Due to the patients' negative attitude towards the placebo and their non-participation, the placebo was removed. The study method was changed from single-blind to open-label. After changing the study method, the new sample size was calculated.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210216050373N1
Registration date:
2021-05-28, 1400/03/07
Registration timing:
registered_while_recruiting
Last update:
2023-02-13, 1401/11/24
Update count:
1
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Registration date
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2021-05-28, 1400/03/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-03-03, 1399/12/13
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Expected recruitment end date
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2022-03-04, 1400/12/13
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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The effect of Spirulina platensis supplement in the treatment of coronavirus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Male and female patients, age ≥18.
The patient is stable in condition and does not need resuscitation.
Signed informed consent form.
Definitive/clinical diagnosis of coronavirus.
The same treatment protocol (coronavirus) in both groups.
oxygen saturation ≤94%.
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(Warfarin), 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.
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
240
More than 1 sample in each individual
Number of samples in each individual:
4
Each patient will be sampled four times, on the first day, the third day, the fifth day, and the seventh day.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At the beginning of the patient's hospitalization before the start of the study, patient demographic information is recorded about 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, are placed in two groups of intervention and control. In our study, due to changing the study method from single-blind to open-label, random blocks of variable size will be used to avoid revealing the last allocation in each block.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-02-17, 1399/11/29
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Ethics committee reference number
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IR.TUMS.IKHC.REC.1399.481
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.02
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ICD-10 code description
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COVID disease
Primary outcomes
1
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Description
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Disease severity
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Timepoint
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The first day, the third day, the fifth day, and the seventh day are the periods of measuring the variables of our study.
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Method of measurement
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Disease severity is measured by the relevant variables: Lymphocyte count, Alanine transaminase, Aspartate transaminase, White Blood Cells, Erythrocyte sedimentation rate, C-Reactive Protein, Hemoglobin, Creatinine, D-Dimer, ferritin, Platelet, Lactate Dehydrogenase, Prothrombin Time, Oxygen saturation and Patient body temperature. Cytokines and chemokines levels, including IL-10, IL-6, IP-10, IFNγ, TNFα, CCL2, and CCL3, are also measured by enzyme-linked immunosorbent assay (ELISA).
Intervention groups
1
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Description
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Intervention group: patients using spirulina platensis supplement plus standard treatment of Covid-19.
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Category
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Treatment - Drugs
2
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Description
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Control group: patients receiving standard Covid-19 treatment alone.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Food Industry Company Berke Sabz Mad Asia
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Proportion provided by this source
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80
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The research results will be presented and published only in the form of reports and articles.
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When the data will become available and for how long
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The access period starts 6 months after the results are published.
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To whom data/document is available
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It will be available to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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Researchers for use in articles and reports, especially systematic review articles.
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From where data/document is obtainable
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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.
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What processes are involved for a request to access data/document
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After making the call(Phone, meet, Email) and providing the necessary documents(Written request), the documents or data files will reach the applicant.
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Comments
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