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IRCT20220509054793N1 IRCT 2022-06-02 Mashhad University of Medical Sciences The effectiveness of Spirulina platensis algae and N-acetyl cysteine for treatment of patients with COVID-19 infection 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 2022-06-22 anticipated 60 Complete https://irct.ir/trial/63426 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 1-2 Patients with COVID-19 infection. Intervention 1: Intervention group I will receive 80 mg/kg/day Spirulina platensis algae along with standard treatment. Intervention 2: Intervention group II will receive 80 mg/kg/day Spirulina platensis algae and twice daily N-acetylcysteine 600 mg along with standard treatment. Intervention 3: Control group will receive standard treatment. Yes - There is a plan to make this available What will be shared: The research data obtained from the main outcomes of the study can be shared freely as 'open data'. When: 6 months after publishing the results To whom: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Conditions: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Where to obtain: Farid Poursadegh provides the data analysis to the applicants via email: drpoursadeghf@gmail.com How to obtain: Applicants can send emails to him and receive a response within a week. Comments:
public Farid Poursadegh
Imam Reza Hospital, Imam Reza Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 drpoursadeghf@gmail.com Mashhad University of Medical Sciences scientific Farid Poursadegh
Imam Reza Hospital, Imam Reza Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 drpoursadeghf@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both 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 U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group I will receive 80 mg/kg/day Spirulina platensis algae along with standard treatment. Intervention group II will receive 80 mg/kg/day Spirulina platensis algae and twice daily N-acetylcysteine 600 mg along with standard treatment Control group will receive standard treatment The duration of hospitalization. Timepoint: Two weeks after intervention. Method of measurement: The number days of hospitalization. Improvement rate of clinical symptoms such as dyspnea and fever. Timepoint: Three months weeks after intervention. Method of measurement: Based on clinical examinations. Possibility of hospitalization in ICU. Timepoint: Two weeks after intervention. Method of measurement: Need to receive intensive care in the patient. Mortality rate. Timepoint: One month after intervention. Method of measurement: Calculating a mortality rate. Acute respiratory distress syndrome rate. Timepoint: Two weeks after intervention. Method of measurement: Patient with acute respiratory distress syndrome. Mashhad University of Medical Sciences Approved 2020-12-05 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)