Effect of Spirulina as a nutritional supplement and drug in Covid-19 patients

Effect of Spirulina as a nutritional supplement and drug in Covid-19 patients

clinical trial with control group , with parallel groups , double-blind , randomized , phase 2on 100 patients.Random Allocation software was used for randomization.

In this study,100 patients with positive covid-19 PCR referred to Imam Reza hospital in Tabriz was randomly admitted to one of the two groups which studied (two groups of drug and placebo). 50 patients entered the intervention group and 50 patients entered the placebo group. Patients information including age , gender , vital signs upon arrival, extent of pulmonary involvement were recorded by CT scan, underlying disease and medication used.patients in the intervention group received 1g of Spirulina capsule 4 time daily,the control group received starch-containing capsules as a placebo. then the patients were followed by telephone for 14 days. Participants and researchers compared the type of blinded capsule and the capsule information in a sealed envelope until the end of study. The effectiveness of the capsule in reducing clinical symptoms such as cough, fatigue and other symptoms, and the paraclinical findings as well as the possible side effects of the drug were measured.

Inclusion criteria: Conformation of covid19 by PCR; consent to participate in the study Exclusion criteria: underlying disease , pregnancy , discontinuation of the drug

50patients received Spirulina capsule 4 time daily as an intervention group and 50 patients received a starch-containing capsule as a control group

Clinical symptoms(cough, fever, etc) ,paraclinical variables (wbc,IL-6, TNF) of the group receiving Spirulina and placebo in patient with COVID19 before and after the intervention

From the patients who volunteered to participate in the study 100 people will be selected by simple random sampling. Randomization method: block Randomization unit:individual Random layers:In each block , people will be matched based on age and gender. Random Allocation tool:Random Allocation software. How to build a random sequence: Using Random Allocation software. Concealment: A random sequence created in a safe place and performed by an independent , non-independent person during the study.

This study is a double-blind study that evaluates the consequences in this study and patients participating in the study will be unaware of the type of supplement received.Supplements will be provided to patients by another person who has no role in completing the questionnaire. Patient will also be informed of existence of two types of supplement (Spirulina and Placebo) when obtaining consent , but will be unaware of which study group they will be placed in. The capsules are exactly the same in shape, color and size and will smell the same due to their proximity for several days.