The primary purpose of this study is to evaluate the efficacy of HC-1119 as an adjuvant treatment for hospitalized COVID-19 male and female patients.
This study is designed as a prospective, superiority, interventionist, placebo-controlled, double-blinded, randomized parallel assignment study. The study evaluates the efficacy and safety of HC- 1119. Participants will be screened for eligibility; the assessment should be completed prior to any randomization to avoid screening failures to a maximum extent. Eligible participants (men and women) will be randomized 1:1 between arms (HC-1119 and placebo). HC-1119 and placebo will be administered orally. The dosing regimen is 160 mg daily for 14 consecutive days. All patients will receive in parallel the standard treatment for COVID -19, according to the institution's protocol. An electronic program will be used to manage randomization and drug shipment. The whole process will be handled in a manner that is blinded for the treatment received to all involved study personnel. The study follow up period will be 28 days after the first treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
602
All-cause mortality risk ratio assessed by the proportion of patient deaths in both study arms.
The proportion of patients reaching score 8 (death) on the COVID-19 ordinal scale at any given time up to 28 days for both study arms.
Time frame: 28 days
Recovery ratio assessed by measuring the proportion of recovered patients in both study arms.
Recovery will be defined as reaching scores 1 (Not hospitalized, no limitations on activities) and 2 (Not hospitalized, limitation on activities and/or requiring home oxygen) on the COVID-19 ordinal scale.
Time frame: 28 days
Recovery ratio assessed by measuring the proportion of recovered patients in both study arms.
Recovery will be defined as reaching scores 1 (Not hospitalized, no limitations on activities) and 2 (Not hospitalized, limitation on activities and/or requiring home oxygen) on the COVID-19 ordinal scale.
Time frame: 14 days
Post-randomization time to recover/alive hospital discharge assessed by the median days (interquartile range) of time to recover.
The median days (interquartile range) of time to recover will be calculated based on the number of days subjects will lead to reach scores 1 and 2 in the COVID-19 ordinal scale.
Time frame: 28 days
Hazard ratio for death assessed by measuring the proportion of deaths by time in both study arms.
The percentage of patients that reached score 8 (death) in the COVID-19 ordinal scale at any given time up to 28 days for both study arms will allow for the calculation of the hazard ratio for death.
Time frame: 28 days
Pharmacokinetics of HC-1119 assessed by area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 14 days
Pharmacokinetics of HC-1119 assessed by area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC 0-t)
Time frame: 14 days
Pharmacokinetics of HC-1119 assessed by peak concentration (Cmax)
Time frame: 14 days
Pharmacokinetics of HC-1119 assessed by peak time (Tmax)
Time frame: 14 days
Pharmacokinetics of HC-1119 assessed by elimination half-life (t 1/2)
Time frame: 14 days
Efficacy of concomitant therapies assessed by sensitivity analysis of the primary, and key secondary outcomes.
Sensitivity analysis of the primary, and key secondary outcomes to evaluate the efficacy of concomitant therapy including off-label use of marketed medications that are intended as treatment for COVID 19 and are given to patient prior to and during the study.
Time frame: 28 days