]>
IRCT20210216050373N1 IRCT 2021-05-28 Tehran University of Medical Sciences The effect of Spirulina platensis supplement in the treatment of coronavirus 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. 2021-03-03 anticipated 240 Complete https://irct.ir/trial/54375 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. 3 COVID-19. Intervention 1: Intervention group: patients using spirulina platensis supplement plus standard treatment of Covid-19. Intervention 2: Control group: patients receiving standard Covid-19 treatment alone. Yes - There is a plan to make this available What will be shared: The research results will be presented and published only in the form of reports and articles. When: The access period starts 6 months after the results are published. To whom: It will be available to researchers working in academic and scientific institutions. Conditions: Researchers for use in articles and reports, especially systematic review articles. Where to obtain: 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. How to obtain: After making the call(Phone, meet, Email) and providing the necessary documents(Written request), the documents or data files will reach the applicant. Comments:
public MohamadAli ZaheriBirgani
Imam Khomeini Hospital Complex, Tohid Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1583 Amzb11@protonmail.com Pasture Institute of Iran scientific Dr. SeyedAhmad SeyedAlinaghi
Imam Khomeini Hospital Complex, Tohid Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1583 s.a.alinaghi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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%. 18 years no limit Both 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. U07.02 COVID disease Treatment - Drugs N/A Intervention group: patients using spirulina platensis supplement plus standard treatment of Covid-19. Control group: patients receiving standard Covid-19 treatment alone. Disease severity. Timepoint: The first day, the third day, the fifth day, and the seventh day are the periods of measuring the variables of our study. Method of measurement: 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). Food Industry Company Berke Sabz Mad Asia Approved 2021-02-17 Ethics committee of Imam khomeini Hospital Complex- Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Tohid Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)