Status:
UNKNOWN
Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients.
Lead Sponsor:
CHRISTUS Health
Collaborating Sponsors:
Pharco Pharmaceuticals
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 rese...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18) prior to performing study procedure.
- Aged ≥ 18 years.
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization.
- Currently hospitalized.
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen on screening.
Exclusion
- Participation in any other clinical trial of an experimental treatment for COVID-19.
- Evidence of multiorgan failure.
- Mechanically ventilated for \> 5 days.
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN).
- Creatinine clearance \< 50 mL/min.
Key Trial Info
Start Date :
August 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04869579
Start Date
August 15 2021
End Date
December 15 2021
Last Update
August 3 2021
Active Locations (1)
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1
CHRISTUS Good Shepherd Medical Center
Longview, Texas, United States, 75601