In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Patients in this trial will undergo treatment for 10 days with either a combination of therapies or placebo. They will then be followed for an additional 20 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Treatment days 1, 4, and 8
10 day treatment
10 Day treatment
ProgenaBiome
Ventura, California, United States
Time to Non-Infectivity by RT-PCR
Time to negative RT-PRC result indicating that patient is no longer infective
Time frame: 6 months
Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score)
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Time frame: 6 months
Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score)
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Time frame: 6 months
Efficacy of Treatment as measured by Titer
Patients will have serum stored for titer testing to compare antibody levels over time
Time frame: 6 months
Efficacy of Treatment as measured by RT-PCR
Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
Time frame: 10 days
Safety of Treatment as Measured by D-Dimer
Blood D-Dimer levels
Time frame: 6 Months
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10 day treatment
10 day treatment
Safety of Treatment as Measured by Pro-Calcitonin
Blood Pro-Calcitonin levels
Time frame: 6 Months
Safety of Treatment as Measured by C-Reactive Protein
Blood CRP levels
Time frame: 6 Months
Safety of Treatment as Measured by Ferritin
Blood ferritin levels
Time frame: 6 Months
Safety of Treatment as Measured by Liver Enzymes
Blood enzyme levels
Time frame: 6 Months
Safety of Treatment as Measured by Complete Blood Count
CBC
Time frame: 6 Months
Safety of Treatment as Measured by Electrolyte Levels
Blood electrolytes
Time frame: 6 Months
Safety of Treatment as Measured by Treatment Related Adverse Events
Presence or absence of Grade 3 or high treatment related adverse events
Time frame: 6 months