Patients with documented COVID-19 infection will be randomized 1:1 to receive Piclidenoson 2 mg Q12H orally with standard care (intervention arm) or standard care alone (control arm).
Name: Piclidenoson
Description: The duration of viral shedding in days since initial diagnosis, as determined by RT-PCR to COVID-19
Measure: Duration of viral shedding in days Time: 28 daysDescription: TTCR is defined as the time (in hours) from initiation of trial treatment until normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours
Measure: Time to clinical recovery (TTCR) in days Time: 28 daysDescription: Proportion of patients experiencing AEs
Measure: Treatment-emergent adverse events (AEs) Time: 28 daysDescription: Proportion of patients requiring non-invasive or mechanical ventilation
Measure: Requirement for non-invasive or mechanical ventilation Time: 28 daysDescription: Duration of hospital stay
Measure: Length of hospital stay in days Time: 28 daysDescription: Ratio of arterial oxygen partial pressure to fractional inspired oxygen
Measure: Estimated PaO2/FiO2 ratio on day of discharge Time: 28 daysDescription: Proportion of patients who die
Measure: All-cause mortality Time: 28 daysDescription: Proportion of patients reaching undetectable COVID-19 virus levels in respiratory secretions at selected timepoints
Measure: Patients reaching undetectable COVID-19 virus levels in respiratory secretions Time: 28 daysDescription: Duration of symptoms and signs of respiratory infection associated with COVID-19
Measure: Duration of symptoms and signs of respiratory infection in days Time: 28 daysDescription: Proportion of patients who need for supportive respiratory management
Measure: Need for supportive respiratory management Time: 28 daysDescription: COVID-19 viral load in respiratory secretions using a semi-quantitative method
Measure: Viral load Time: 28 daysDescription: Proportion of patients experiencing AEs
Measure: Treatment-emergent serious AEs (SAEs) Time: 28 daysDescription: Rate of AEs leading to early discontinuation of trial treatment
Measure: AEs leading to withdrawal Time: 28 daysDescription: Proportion of patients experiencing treatment-emergent changes in clinical laboratory
Measure: Treatment-emergent abnormalities in clinical laboratory parameters Time: 28 daysAllocation: Randomized
Parallel Assignment
There is one SNP
Piclidenoson for Treatment of COVID-19 Patients with documented COVID-19 infection will be randomized 1:1 to receive Piclidenoson 2 mg Q12H orally with standard care (intervention arm) or standard care alone (control arm). --- Q12H ---
COVID-19 Coronavirus Infection Coronavirus Infections Severe Acute Respiratory Syndrome Upon admission to the hospital, patients with documented COVID-19 infection will be randomized 1:1 to receive Piclidenoson 2 mg Q12H orally with standard care (intervention arm) or standard care alone (control arm). --- Q12H ---