SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT04333472

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Piclidenoson for Treatment of COVID-19 - A Randomized Open Label Pilot Trial

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).

NCT04333472 COVID-19 Coronavirus Infection
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

1 Interventions

Name: Piclidenoson

Description: Piclidenoson 2 mg orally every 12 hours for up to 21 days
Type: Drug
Group Labels: 1

Piclidenoson


Primary Outcomes

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 days

Description: 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 days

Description: Proportion of patients experiencing AEs

Measure: Treatment-emergent adverse events (AEs)

Time: 28 days

Secondary Outcomes

Description: Proportion of patients requiring non-invasive or mechanical ventilation

Measure: Requirement for non-invasive or mechanical ventilation

Time: 28 days

Description: Duration of hospital stay

Measure: Length of hospital stay in days

Time: 28 days

Description: Ratio of arterial oxygen partial pressure to fractional inspired oxygen

Measure: Estimated PaO2/FiO2 ratio on day of discharge

Time: 28 days

Description: Proportion of patients who die

Measure: All-cause mortality

Time: 28 days

Description: 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 days

Description: 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 days

Description: Proportion of patients who need for supportive respiratory management

Measure: Need for supportive respiratory management

Time: 28 days

Description: COVID-19 viral load in respiratory secretions using a semi-quantitative method

Measure: Viral load

Time: 28 days

Description: Proportion of patients experiencing AEs

Measure: Treatment-emergent serious AEs (SAEs)

Time: 28 days

Description: Rate of AEs leading to early discontinuation of trial treatment

Measure: AEs leading to withdrawal

Time: 28 days

Description: Proportion of patients experiencing treatment-emergent changes in clinical laboratory

Measure: Treatment-emergent abnormalities in clinical laboratory parameters

Time: 28 days

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q12H

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 ---



HPO Nodes