Piclidenoson for Treatment of COVID-19
- Registration Number
- NCT04333472
- Lead Sponsor
- Can-Fite BioPharma
- Brief Summary
Patients with documented moderate COVID-19 infection will be randomized 1:1 to receive piclidenoson 2 mg Q12H orally with standard supportive care (SSC - intervention arm) or placebo orally with SSC (control arm) for up to 28 days.
- Detailed Description
This is a randomized, double-blind, placebo-controlled, pilot trial of piclidenoson 2 mg Q12H added to SSC, compared to placebo plus SSC, in a population of hospitalized subjects with "Moderate" or "Severe" COVID-19 per U.S. National Institutes of Health (NIH) Coronavirus Disease 2019 (COVID-19) Treatment Guidelines (2020). Subjects will be randomized according to a 1:1 ratio to one of the trial arms, and treated for up to 28 days, at the discretion of the Investigator. Piclidenoson 2 mg and placebo are supplied as matching tablets for oral administration.
Following initial diagnosis of COVID-19, and after having provided informed consent, subjects will be randomized according to 1:1 ratio to one of the trial arms on Day 0. SSC will be implemented and documented for all subjects, and maintained throughout the treatment period.
Vital signs (temperature, blood pressure, pulse rate per minute, respiratory rate per minute, oxygen saturation (SpO2), and PaO2/FiO2) of subjects will be monitored twice daily according to SSC. Parameters of clinical, respiratory, and vital status will be collected daily. Viral shedding will be assessed on a regular basis. Samples for pharmacokinetic (PK) analysis will be collected on Day 4.
Efficacy of piclidenoson will be assessed by clinical, respiratory, and virologic parameters. Safety and tolerability of piclidenoson will be assessed by adverse event (AE) monitoring, vital signs assessment, electrocardiograms (ECGs), and clinical laboratory tests (complete blood count (CBC) and extended chemistry panel). Adverse events will be graded by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo every 12 hours orally added to standard of care Piclidenoson Piclidenoson Piclidenoson 2 mg every 12 hours orally added to standard of care
- Primary Outcome Measures
Name Time Method Proportion of subjects alive and free of respiratory failure 29 days Proportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or extracorporeal membrane oxygenation) at Day 29
Treatment-emergent adverse events (AEs) 29 days Proportion of patients experiencing AEs
Proportion of subjects discharged home alive 29 days Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29
- Secondary Outcome Measures
Name Time Method Ventilator-free days 29 days Ventilator-free days to Day 29
Treatment-emergent serious AEs (SAEs) 29 days Proportion of patients experiencing SAEs
Duration of ICU stay 29 days Duration (days) of ICU stay
Duration of need for supplemental oxygen 29 days Duration (days) of need for supplemental oxygen
Incidence of meeting safety-related stopping rules 29 days Proportion of patients who meet study safety-related stopping rules
Clinical status 29 days • Clinical status at Day 29 on NIAID 8-point ordinal scale (NIH 2020):
1. Not hospitalized, no limitations
2. Not hospitalized, with limitations
3. Hospitalized, no active medical problems
4. Hospitalized, not on oxygen
5. Hospitalized, on oxygen
6. Hospitalized, on high-flow oxygen or noninvasive mechanical ventilation
7. Hospitalized, on mechanical ventilation or ECMO
8. DeathTime to improvement 29 days Time (days) to improvement of 2 points on 7-point ordinal clinical scale
Incidence of mechanical ventilation 29 days Proportion of patients who require mechanical ventilation
Time to virus negativity 29 days Time (days) to virus negativity by RT-PCR, defined as absence of SARS CoV 2 on 2 consecutive days of sampling
SARS-CoV-2 viral load 29 days SARS-CoV-2 viral load (number of copies) by quantitative RT-PCR
Serum cytokine levels 29 days Change from baseline in serum concentrations of cytokines
Incidence of Intensive Care Unit (ICU) admission 29 days Proportion of patients who require ICU admission
Time to hospital discharge 29 days Time (days) to hospital discharge
AEs leading to withdrawal 29 days Proportion of patients experiencing AEs leading to early discontinuation of trial treatment
Pharmacokinetics of piclidenoson in this patient population 5 days Plasma concentrations over time of piclidenoson
Treatment-emergent abnormalities in clinical laboratory parameters or electrocardiograms (ECGs) 29 days Proportion of patients experiencing treatment-emergent changes in clinical laboratory parameters or ECGs
Trial Locations
- Locations (6)
Hadassah Medical Center
🇮🇱Jerusalem, Israel
"Sfantul Ioan cel Nou" County Emergency Hospital Suceava
🇷🇴Suceava, Romania
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
II Multiprofile Hospital for Active Treatment - Sofia EAD
🇧🇬Sofia, Bulgaria
IV Multiprofile Hospital for Active Treatment - Sofia EAD
🇧🇬Sofia, Bulgaria
Clinical Hospital for Infectious Diseases "St. Parascheva" Iasi
🇷🇴Iaşi, Romania