Protocol summary
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Study aim
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Determination of the therapeutic effect of the Spirulina platensis algae (Arthrospira, blue-green algae) and N-acetyl cysteine in patients with COVID-19 infection
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Design
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This randomized, phase I-II, and single-blind clinical trial with parallel and control groups will be conducted on 60 patients who will be randomly selected using the blocks.
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Settings and conduct
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Patients with COVID-19 infection referring to Imam Reza Hospital and Ghaem Hospital are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. Patients will receive Spirulina platensis algae + N-acetyl cysteine + standard treatment. The person responsible for data collection is blind to group allocation and the type of intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with COVID-19 infection base on clinical manifestations, chest CT scan and PCR test results; age over 18 years; the oxygen saturation of patient is 85 percent or greater at rest.
Exclusion criteria: Having chronic lung disease; pregnant women; having autoimmune disease; history of allergy to the seaweed or its derivatives; history of bronchospasm after using of N-acetylcysteine; having chronic liver disease; history of phenylketonuria; having bleeding; neutrophil count of less than 500 mmc; A platelet count of less than 2000 mmc; having acute hepatitis.
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Intervention groups
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The intervention group I will receive 80 mg/kg/day Spirulina platensis algae + standard treatment, the intervention group II 80 mg/kg/day Spirulina platensis algae + twice daily N-acetylcysteine 600 mg + standard treatment. The control group standard treatment.
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Main outcome variables
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Evaluation of the duration of hospitalization, improvement rate of clinical symptoms such as dyspnea and fever, possibility of hospitalization in ICU and Mortality rate
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220509054793N1
Registration date:
2022-06-02, 1401/03/12
Registration timing:
prospective
Last update:
2022-08-14, 1401/05/23
Update count:
1
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Registration date
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2022-06-02, 1401/03/12
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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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2022-06-22, 1401/04/01
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Expected recruitment end date
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2023-06-22, 1402/04/01
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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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A clinical trial to compare the effectiveness of the Spirulina platensis algae (Arthrospira, blue-green algae) and N-acetyl cysteine with standard treatment in patients with COVID-19 infection
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Public title
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The effectiveness of Spirulina platensis algae and N-acetyl cysteine for treatment of patients with COVID-19 infection
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with COVID-19 infection base on clinical manifestations, chest CT scan and PCR test results
Age over 18 years
The oxygen saturation of patient is 85 percent or greater at rest
Exclusion criteria:
having chronic lung disease
Pregnant women
Having autoimmune disease
History of allergy to the seaweed or its derivatives
History of bronchospasm after using of N-acetylcysteine
Having chronic liver disease
History of phenylketonuria
Having bleeding (Massive hemoptysis, gastrointestinal bleeding, epistaxis, purpura, ecchymosis)
Neutrophil count of less than 500 mmc
A platelet count of less than 2000 mmc
Having acute hepatitis
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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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1-2
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, we will use the restricted randomization method of block randomization. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Random allocation software software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Patients with COVID-19 infection referring to Imam Reza Hospital and Ghaem Hospital, Mashhad, Iran are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The lids of the letter envelopes are glued and placed inside a box. The person responsible for data collection is blind to group allocation and the type of intervention. Patients will be aware of their medication. Intervention group I will receive the Spirulina platensis algae along with standard treatment, Intervention group II will receive the Spirulina platensis algae and N-acetyl cysteine along with standard treatment and control will receive standard treatment.
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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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2020-12-05, 1399/09/15
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Ethics committee reference number
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IR.MUMS.REC.1399.528
Health conditions studied
1
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Description of health condition studied
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Patients with COVID-19 infection
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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The duration of hospitalization
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Timepoint
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Two weeks after intervention
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Method of measurement
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The number days of hospitalization
2
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Description
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Improvement rate of clinical symptoms such as dyspnea and fever
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Timepoint
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Three months weeks after intervention
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Method of measurement
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Based on clinical examinations
3
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Description
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Possibility of hospitalization in ICU
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Timepoint
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Two weeks after intervention
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Method of measurement
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Need to receive intensive care in the patient
4
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Description
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Mortality rate
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Timepoint
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One month after intervention
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Method of measurement
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Calculating a mortality rate
Secondary outcomes
1
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Description
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Acute respiratory distress syndrome rate
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Timepoint
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Two weeks after intervention
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Method of measurement
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Patient with acute respiratory distress syndrome
Intervention groups
1
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Description
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Intervention group I will receive 80 mg/kg/day Spirulina platensis algae along with standard treatment.
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Category
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Treatment - Drugs
2
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Description
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Intervention group II will receive 80 mg/kg/day Spirulina platensis algae and twice daily N-acetylcysteine 600 mg along with standard treatment
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Category
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Treatment - Drugs
3
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Description
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Control group will receive standard treatment
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Category
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Treatment - Drugs
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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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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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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Academic
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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The research data obtained from the main outcomes of the study can be shared freely as 'open data'.
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When the data will become available and for how long
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6 months after publishing the results
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To whom data/document is available
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The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
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Under which criteria data/document could be used
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The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
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From where data/document is obtainable
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Farid Poursadegh provides the data analysis to the applicants via email: drpoursadeghf@gmail.com
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What processes are involved for a request to access data/document
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Applicants can send emails to him and receive a response within a week.
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Comments
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