Phase 2b clinical trial to evaluate the safety and efficacy of intranasal application of GX-03 as a treatment and prevention for COVID-19.
Phase 2b clinical trial to evaluate the safety and efficacy of intranasal application of GX-03 as a treatment and prevention for COVID-19. Patients hospitalized with a diagnosis of mild to moderate COVID-19 will be evaluated for a period of five days. Participating health care providers will be evaluated for a period of ten days. Swab samples will be collected from the right and left anterior nostrils at the beginning of the study, as well as three times per day in the treatment arm for five days. Swab samples will be collected from the right and left anterior nostrils at the beginning and end of the prevention arm. Samples will be subjected to biomolecular tests and viral cultures to assess positivity and disease progression. Safety will be evaluated through standard measures of erythema and edema in the nasal mucosa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
Same dosage used in Bactroban Nasal studies.
Viscous ointment similar in form to study drug.
Gorgas Memorial Research Hospital
Panama City, Panama
Hospital Modular COVID-19
Panama City, Panama
Hospital Santo Tomas
Panama City, Panama
Reduction of 60% in viral load from baseline
Time to achieve a 60% reduction in viral load from baseline.
Time frame: 5 days
Primary Safety analysis
To evaluate the incidence rate(s) of non-serious and serious adverse events associated with administration of the study product.
Time frame: 5-10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.