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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 01 Jun 2020

At a glance

  • Drugs Piclidenoson (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Expanded access; Therapeutic Use
  • Sponsors Can-Fite BioPharma
  • Most Recent Events

    • 01 Jun 2020 Status changed from not yet recruiting to recruiting, according to a Can-Fite Biopharma media release.
    • 01 Jun 2020 According to a Can-Fite Biopharma media release, company commenced the trial, it has not enrolled patients due to the decreased number of COVID-19 cases in Israel.
    • 01 Jun 2020 According to a Can-Fite Biopharma media release, company filed a pre-IND meeting request with the U.S. FDA. Following the FDAs guidance from the pre-IND meeting, company plans to submit an IND application.During the first quarter, company also entered into a collaborative research agreement with the Lewis Katz School of Medicine at Temple University, Philadelphia to study the anti-viral activity of Piclidenoson on COVID-19 viral load.

Trial Overview

Purpose

This compassionate use program will use Piclidenoson to treat coronavirus patients in Israel. 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).

Primary Endpoints

Duration of viral shedding in days

description: The duration of viral shedding in days since initial diagnosis, as determined by RT-PCR to COVID-19
time_frame: 28 days

Time to clinical recovery (TTCR) in 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
time_frame: 28 days

Treatment-emergent adverse events (AEs)

description: Proportion of patients experiencing AEs
time_frame: 28 days

Other Endpoints

Requirement for non-invasive or mechanical ventilation

description: Proportion of patients requiring non-invasive or mechanical ventilation
time_frame: 28 days

Length of hospital stay in days

description: Duration of hospital stay
time_frame: 28 days

Estimated PaO2/FiO2 ratio on day of discharge

description: Ratio of arterial oxygen partial pressure to fractional inspired oxygen
time_frame: 28 days

All-cause mortality

description: Proportion of patients who die
time_frame: 28 days

Patients reaching undetectable COVID-19 virus levels in respiratory secretions

description: Proportion of patients reaching undetectable COVID-19 virus levels in respiratory secretions at selected timepoints
time_frame: 28 days

Duration of symptoms and signs of respiratory infection in days

description: Duration of symptoms and signs of respiratory infection associated with COVID-19
time_frame: 28 days

Need for supportive respiratory management

description: Proportion of patients who need for supportive respiratory management
time_frame: 28 days

Viral load

description: COVID-19 viral load in respiratory secretions using a semi-quantitative method
time_frame: 28 days

Treatment-emergent serious AEs (SAEs)

description: Proportion of patients experiencing AEs
time_frame: 28 days

AEs leading to withdrawal

description: Rate of AEs leading to early discontinuation of trial treatment
time_frame: 28 days

Treatment-emergent abnormalities in clinical laboratory parameters

description: Proportion of patients experiencing treatment-emergent changes in clinical laboratory
time_frame: 28 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 40

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion Criteria

1. Female and male patients over the age of 18. 2. Confirmed COVID-19 infection by PCR analysis. 3. Hospitalized at Hasharon Medical Center. 4. Display moderate to severe symptoms of respiratory infection. 5. Willing and able to convey informed consent. 6. Willing and able to comply with all study procedures 7. Female patients of childbearing potential and male patients 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 patients of childbearing potential are all those except patients who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal.

Patient Exclusion Criteria

1. Treatment with interferons, immunomodulators and/or immunosuppressive or B-cell depleting medications within 12 months before screening. 2. Previous receipt of Piclidenoson. 3. Patients with respiratory infection requiring invasive or non-invasive ventilatory support (bipap or intubation and mechanical ventilation). 4. Participation in a clinical trial with use of any investigational drug within 30 days before screening. 5. History of any of the following diseases or conditions: - Advanced or decompensated liver disease (presence or history of bleeding varices, ascites, encephalopathy or hepato-renal syndrome) - Immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) that requires use of systemic corticosteroids in the 6 months before screening. - Gastrointestinal disease which could interfere with the absorption of Piclidenoson. - Any malignancy within 5 years. - 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 ≥500 msec. - A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, congenital Long QT Syndrome. - Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades de Pointes, unless the patient can be screened and monitored under the guidelines proposed by Giudicessi (Mayo Clinic Proceedings 2020). - Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment. - Pancreatitis. - Severe or uncontrolled psychiatric disorder. - Active seizure disorder defined by either an untreated seizure disorder or continued seizure activity within the preceding year despite treatment with anti-seizure medication. - Bone marrow or solid organ transplantation. - Other significant medical condition that may require intervention during the trial (such as uncontrolled diabetes or thyroid disease), or patients for whom participation in the trial would increase their risk. - Current alcohol abuse. - Drug abuse within the previous 6 months before screening, with the exception of cannabinoids and their derivatives. 6. Any of the following abnormal laboratory test in the 12 months prior to enrollment: - Platelet count <90,000 cells/mm3 - White blood cell (WBC) count <3,000 cells/mm3 - Absolute neutrophil count (ANC) <1,500 cells/mm3 - Hemoglobin <11 g/dL for women and <12 g/dL for men - Estimated creatinine clearance (CrCl) < 50 mL/min by Cockroft-Gault formulation - Bilirubin level ≥ 2.5 mg/dL unless due to Gilbert's syndrome - Serum albumin level <3.5 g/dL - International normalized ratio (INR) ≥1.5.

Trial Details

Identifiers

Identifier Owner
NCT04333472 ClinicalTrials.gov: US National Institutes of Health
CAN-COR1 -

Organisations

  • Sponsors Can-Fite BioPharma
  • Affiliations Can-Fite BioPharma

Trial Dates

  • Initiation Dates

    Planned : 06 Apr 2020

  • Primary Completion Dates

    Planned : 06 Jun 2020

  • End Dates

    Planned : 06 Jun 2020

Other Details

  • Design open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location Israel
  • Focus Adverse reactions; Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
PiclidenosonPrimary Drug Oral
-

Piclidenoson

Piclidenoson 2 mg every 12 hours orally added to standard of care
Drug: Piclidenoson (Piclidenoson 2 mg orally every 12 hours for up to 21 days) Other Name: CF101

Standard of Care

Standard treatment

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Zivit Harpaz
+972-3-9241114
Zivit@canfite.co.il
show details
Can-Fite BioPharma Ltd
-

Centres

Centre Name Location Trial Centre Country
Can-Fite BioPharma
-
-
Can-Fite BioPharma Ltd
-
-
Rabin Medical Center
-
-
Rabin Medical Center Petah tikva Israel

Trial History

Event Date Event Type Comment
01 Jun 2020 Status change - recruiting Status changed from not yet recruiting to recruiting, according to a Can-Fite Biopharma media release. Updated 04 Jun 2020
01 Jun 2020 Other trial event According to a Can-Fite Biopharma media release, company commenced the trial, it has not enrolled patients due to the decreased number of COVID-19 cases in Israel. Updated 04 Jun 2020
01 Jun 2020 Other trial event According to a Can-Fite Biopharma media release, company filed a pre-IND meeting request with the U.S. FDA. Following the FDAs guidance from the pre-IND meeting, company plans to submit an IND application.During the first quarter, company also entered into a collaborative research agreement with the Lewis Katz School of Medicine at Temple University, Philadelphia to study the anti-viral activity of Piclidenoson on COVID-19 viral load. Updated 04 Jun 2020
13 Apr 2020 Other trial event According to a Can-Fite Biopharma media release, the company has received approval from the Institutional Review Board (IRB) at Rabin Medical Center to initiate this pilot clinical study. Patient enrollment and dosing will begin immediately. Updated 15 Apr 2020
07 Apr 2020 Other trial event New source identified and integrated: (ClinicalTrials.gov: US National Institutes of Health: NCT04333472). Updated 07 Apr 2020
06 Apr 2020 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 07 Apr 2020
31 Mar 2020 New trial record New trial record Updated 31 Mar 2020
23 Mar 2020 Other trial event According to a Can-Fite Biopharma media release, the company has submitted Piclidenoson for a compassionate use program to treat coronavirus patients to the Institutional Review Board at Rabin Medical Center. If approved, the compassionate use program will be led by Dr. Dror Diker, M.D., Head of Internal Medicine D at the Rabin Medical Center. Patients would be treated at Rabins Golda Hasharon Campus which is currently positioned to treat coronavirus patients in a specialized setting. Updated 31 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Can-Fite BioPharma. Can-Fite: Piclidenoson is Submitted for Compassionate Use Treatment for Coronavirus Patients in Israel. Media-Rel 2020;.

    Media Release
  3. Can-Fite BioPharma. Can Fite Received Approval for COVID-19 Clinical Trial in Israel, Patient Enrollment and Dosing to Commence Immediately. Media-Rel 2020;.

    Media Release
  4. Can-Fite BioPharma. Can-Fite Reports First Quarter 2020 Financial Results & Provides Clinical Update. Media-Rel 2020;.

    Media Release
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