The impact of selenium supplementation in the treatment of COVID 19 positive patients in Rwanda

A. Background Socio-economic pressure on health care systems and health care workers, fragile economies can suffer double given transmission mode and rate of COVID 19 if innovative strategies are not applied. Selenium supplementation has proven prevention evidence in cases of coxsackievirus and other viruses in many parts of the world. Little is known about the role of selenium in the treatment of COVID19 specifically. However, general knowledge of SARS viruses points to significant benefits of selenium in the management of enveloped viruses. Selenium deficiency in the body allows dormant enveloped viruses including SARS2-COVID19 through mutation synthesis to be more active and harmful strains. This enables these infections to progress into a disease that can range from mild to life-threatening diseases. Selenium is hypothesized to act as a transcriptase inhibitor hence leading to reduced viral replication. Selenium is known to boost the immune system and as a detoxifying mineral. B. Goals and Objectives The general objective of this project is to determine the impact of selenium supplement on COVID 19 treatment outcome. Specific objectives of this study are: • To determine the effect of selenium supplement on the immune response to COVID19. • To determine the effect of selenium supplement on reducing COVID 19 severity & length of hospital stay in positive patients • To determine the effect of selenium supplementation on COVID-19 on mortality rate. C. Methods All participants will receive the standard treatment of care irrespective of the experimental assignment. Unblinding will only be allowed in times of emergency related to side effects of the prescribed intervention. The trial intervention or placebo will be provided to the participant once daily or 12 hours, 8 hours, 6-hour schedules or even more to the discretion of the physician if the condition was critical. The intervention and placebo will be blinded to the investigator and patient. Coding will be used and will be disclosed to independent statistician during analysis time D. Expected outcomes The primary outcome measures for this study will be the changes in immune markers including CD4/CD8 T-cell counts, or change of cytokines (IL1, IL-6) and other inflammatory markers (CRP) that will allow us to determine the impact of selenium supplementation in the management of COVID19. For analyses of the CD4 T-cell count changes, patient samples will be taken at baseline (1st day of interaction), and at 7th day, 14th day, and every other 7th day until the participant exits from the treatment facility. Secondary outcomes will include viral suppression, mortality, and length of hospital stay, admission to HDU, Admission to ICU, mechanical ventilation and adverse events.