ProgenaBiome
Ventura, California, 93003, United States
NCT Number: NCT04482686
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Ventura, California, 93003, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment days 1, 4, and 8
Other names: Soolantra, Stromectol, Sklice
10 day treatment
Other names: Doxy-100, Monodox, Oracea, Targadox, Acticlate, Morgidox, Avidoxy, Doryx MPC, Mondoxyne NL, Dory
10 Day treatment
Other names: Zinc sulphate
10 day treatment
Other names: cholecalciferol-D3
10 day treatment
Other names: L-ascorbic acid
Time frame: 6 months
Time to negative RT-PRC result indicating that patient is no longer infective
Time frame: 6 months
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 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
Patients will have serum stored for titer testing to compare antibody levels over time
Time frame: 10 days
Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
Time frame: 6 Months
Blood D-Dimer levels
Time frame: 6 Months
Blood Pro-Calcitonin levels
Time frame: 6 Months
Blood CRP levels
Time frame: 6 Months
Blood ferritin levels
Time frame: 6 Months
Blood enzyme levels
Time frame: 6 Months
CBC
Time frame: 6 Months
Blood electrolytes
Time frame: 6 months
Presence or absence of Grade 3 or high treatment related adverse events
ProgenaBiome
Other
A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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