Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04869579
Status:
UNKNOWN
Last Update Posted:
2021-08-03
First Post:
2021-04-29
Brief Title:
Selenium as a Potential Treatment for Moderately-ill Severely-ill and Critically-ill COVID-19 Patients
Sponsor:
CHRISTUS Health
Organization:
CHRISTUS Health
Study Overview
Official Title:
Selenium as a Potential Treatment for Moderately-ill Severely-ill and Critically-ill COVID-19 Patients
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SeCOVID
Brief Summary:
Given its anti-viral anti-oxidative immune-enhancing cytokine-modulating and anticoagulant properties the investigators hypothesize that Selenium infusion at supranutritional doses for moderately-ill severely-ill and critically-ill COVID-19 patients will prevent further clinical deterioration thus decreasing overall mortality and improving survival To test this hypothesis a prospective single-center phase II trial is proposed to assess the efficacy of Selenium in hospitalized adult patients with moderate severe and critical COVID-19 infections
Detailed Description:
COVID-19 is a respiratory illness that is caused by the novel SARS-CoV-2 Illness severity can widely range from mild moderate severe featuring pneumonia to critical Despite ongoing extensive research to find a cure for COVID-19 there had been no proven efficacious and widely-available treatment for the disease With the death toll rising in various parts of the US and the world it is imperative that investigators work on determining new therapeutic modalities This study relates to inpatient and critical care for COVID-19 patients
The role of Selenium Se as a trace element involved in many biological processes and reactions is well established in various organisms Particularly Selenium is known to have anti-viral anti-oxidative cytokine-modulating immune-enhancing and anticoagulant properties that might be beneficial in COVID-19 infections given the pathophysiological processes involved in the disease Multiple preclinical and clinical studies have shed the light on the various effects exerted by Selenium in multiple inflammatory conditions including acute lung injury and acute respiratory distress syndrome as well as viral infections including HIV and Influenza The study team aims to explore the possible role of Selenium in mitigating the inflammatory processes involved in COVID-19 infections and hence its effect on disease progression and mortality
Patients with COVID-19 who exhibit the signs and symptoms of moderate or severe infection or are critically ill will receive Selenium infusion for 14 days The working hypothesis of this trial is that selenium treatment would decrease the death rates and increase the rate of hospital discharges among hospitalized patients
The role of Selenium Se as a trace element involved in many biological processes and reactions is well established in various organisms Particularly Selenium is known to have anti-viral anti-oxidative cytokine-modulating immune-enhancing and anticoagulant properties that might be beneficial in COVID-19 infections given the pathophysiological processes involved in the disease Multiple preclinical and clinical studies have shed the light on the various effects exerted by Selenium in multiple inflammatory conditions including acute lung injury and acute respiratory distress syndrome as well as viral infections including HIV and Influenza The study team aims to explore the possible role of Selenium in mitigating the inflammatory processes involved in COVID-19 infections and hence its effect on disease progression and mortality
Patients with COVID-19 who exhibit the signs and symptoms of moderate or severe infection or are critically ill will receive Selenium infusion for 14 days The working hypothesis of this trial is that selenium treatment would decrease the death rates and increase the rate of hospital discharges among hospitalized patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None