NCT04333472

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started Jan 2021

Typical duration for phase_2 covid19

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

January 6, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2022

Completed
Last Updated

April 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

April 1, 2020

Last Update Submit

April 21, 2022

Conditions

COVID-19Coronavirus Infection

Keywords

PiclidenosonCF101SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

  • Proportion of subjects alive and free of respiratory failure

    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

    29 days

  • Proportion of subjects discharged home alive

    Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29

    29 days

  • Treatment-emergent adverse events (AEs)

    Proportion of patients experiencing AEs

    29 days

Secondary Outcomes (16)

  • Clinical status

    29 days

  • Time to improvement

    29 days

  • Incidence of mechanical ventilation

    29 days

  • Ventilator-free days

    29 days

  • Incidence of Intensive Care Unit (ICU) admission

    29 days

  • +11 more secondary outcomes

Study Arms (2)

Piclidenoson

EXPERIMENTAL

Piclidenoson 2 mg every 12 hours orally added to standard of care

Drug: Piclidenoson

Placebo

PLACEBO COMPARATOR

Placebo every 12 hours orally added to standard of care

Drug: Placebo

Interventions

PiclidenosonDRUG

Piclidenoson 2 mg orally every 12 hours for up to 28 days

Also known as: CF101
Piclidenoson
PlaceboDRUG

Placebo orally every 12 hours for up to 28 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized subjects 18 to 85 years of age, inclusive
  • Able and willing to sign informed consent
  • Molecular (RT-PCR) diagnosis of SARS-CoV-2 infection
  • Moderate or Severe illness per NIH COVID-19 Treatment Guidelines:
  • "Moderate" Illness:
  • Symptoms such as cough, fever, sore throat, malaise, myalgias, headache; and
  • Evidence of lower respiratory tract disease by clinical assessment and/or imaging; and
  • SpO2 \>93% on room air at sea level
  • "Severe" Illness, including any of the following:
  • Respiratory rate \>30 breaths/minute; or
  • SpO2 ≤93% on room air at sea level; or
  • Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300; or
  • Lung infiltrates \>50% of pulmonary volume on imaging
  • Female subjects must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of investigational product
  • Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Female subjects of childbearing potential are all those except subjects who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal.
  • +7 more criteria

You may not qualify if:

  • \. "Critical" Illness, per NIH COVID-19 Treatment Guidelines, including any of the following:
  • Respiratory failure; or
  • Septic shock; or
  • Multiple organ dysfunction
  • Subjects who require mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
  • Participation in another clinical trial concurrently
  • Concurrent treatment with immunomodulators or anti-rejection drugs
  • Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
  • History of any of the following diseases or conditions:
  • Advanced or decompensated liver disease (including presence or history of bleeding varices, ascites, encephalopathy, or hepato-renal syndrome)
  • Inability to swallow tablets, or gastrointestinal disease which could interfere with the absorption of piclidenoson
  • Any malignancy within 5 years before screening; exceptions are superficial dermatologic malignancies (e.g., squamous cell or basal cell skin cancer treated with curative intent)
  • Cardiomyopathy, significant ischemic cardiac or cerebrovascular disease (including history of angina, myocardial infarction, or interventional procedure for coronary artery disease), or cardiac rhythm disorder
  • QTcF interval on an average of triplicate ECGs \>450 milliseconds (msec) for males or \>470 msec for females (except when QT prolongation is associated with right or left bundle branch block, in which case enrollment is allowed)
  • Any condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, congenital Long QT Syndrome
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

II Multiprofile Hospital for Active Treatment - Sofia EAD

Sofia, Bulgaria

Location

IV Multiprofile Hospital for Active Treatment - Sofia EAD

Sofia, Bulgaria

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Clinical Hospital for Infectious Diseases "St. Parascheva" Iasi

Iași, Romania

Location

"Sfantul Ioan cel Nou" County Emergency Hospital Suceava

Suceava, Romania

Location

Related Publications (2)

  • Fishman P, Cohen S. The A3 adenosine receptor (A3AR): therapeutic target and predictive biological marker in rheumatoid arthritis. Clin Rheumatol. 2016 Sep;35(9):2359-62. doi: 10.1007/s10067-016-3202-4. Epub 2016 Feb 17.

    PMID: 26886128BACKGROUND

  • Cohen S, Fishman P. Targeting the A3 adenosine receptor to treat cytokine release syndrome in cancer immunotherapy. Drug Des Devel Ther. 2019 Jan 30;13:491-497. doi: 10.2147/DDDT.S195294. eCollection 2019.

    PMID: 30787591BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

CF101

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Zivit Harpaz

    Can-Fite BioPharma Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 3, 2020

Study Start

January 6, 2021

Primary Completion

March 6, 2022

Study Completion

April 21, 2022

Last Updated

April 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

To be determined

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
January 2021, indefinitely
Access Criteria
To be determined

Locations

BU(2)RO(2)IL(2)