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Piclidenoson for Treatment of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333472
Recruitment Status : Not yet recruiting
First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
Rabin Medical Center
Information provided by (Responsible Party):
Can-Fite BioPharma

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
COVID-19 Coronavirus Infection Drug: Piclidenoson Phase 2

Detailed Description:
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). Piclidenoson will be administered on an empty stomach, i.e, 1 hour before or 2 hours after eating. Patients' vital signs (temperature, blood pressure, pulse rate per minute, breath rate per minute and oxygen saturation), will be monitored according to standard of care (SoC). Symptom questionnaires will be collected from patients once daily during the period of hospitalization. Efficacy of Piclidenoson will be assessed by analysis of COVID-19 (Fluxergy, Irvine CA), in respiratory secretions obtained by nasopharyngeal and oropharyngeal swabs, collected consecutively at day 1, 3, 5, 7, 10, 14, 21 and 28 following initial diagnosis, in addition to its effect on different clinical outcomes. Safety and tolerability of Piclidenoson will be assessed by AE monitoring, vital signs and ECG assessment and clinical laboratory tests (CBC, and extended chemistry panel).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Piclidenoson for Treatment of COVID-19 - A Randomized Open Label Pilot Trial
Estimated Study Start Date : April 6, 2020
Estimated Primary Completion Date : June 6, 2020
Estimated Study Completion Date : July 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

No Intervention: Standard of Care
Standard treatment



Primary Outcome Measures :
  1. Duration of viral shedding in days [ Time Frame: 28 days ]
    The duration of viral shedding in days since initial diagnosis, as determined by RT-PCR to COVID-19

  2. Time to clinical recovery (TTCR) in days [ Time Frame: 28 days ]
    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

  3. Treatment-emergent adverse events (AEs) [ Time Frame: 28 days ]
    Proportion of patients experiencing AEs


Secondary Outcome Measures :
  1. Requirement for non-invasive or mechanical ventilation [ Time Frame: 28 days ]
    Proportion of patients requiring non-invasive or mechanical ventilation

  2. Length of hospital stay in days [ Time Frame: 28 days ]
    Duration of hospital stay

  3. Estimated PaO2/FiO2 ratio on day of discharge [ Time Frame: 28 days ]
    Ratio of arterial oxygen partial pressure to fractional inspired oxygen

  4. All-cause mortality [ Time Frame: 28 days ]
    Proportion of patients who die

  5. Patients reaching undetectable COVID-19 virus levels in respiratory secretions [ Time Frame: 28 days ]
    Proportion of patients reaching undetectable COVID-19 virus levels in respiratory secretions at selected timepoints

  6. Duration of symptoms and signs of respiratory infection in days [ Time Frame: 28 days ]
    Duration of symptoms and signs of respiratory infection associated with COVID-19

  7. Need for supportive respiratory management [ Time Frame: 28 days ]
    Proportion of patients who need for supportive respiratory management

  8. Viral load [ Time Frame: 28 days ]
    COVID-19 viral load in respiratory secretions using a semi-quantitative method

  9. Treatment-emergent serious AEs (SAEs) [ Time Frame: 28 days ]
    Proportion of patients experiencing AEs

  10. AEs leading to withdrawal [ Time Frame: 28 days ]
    Rate of AEs leading to early discontinuation of trial treatment

  11. Treatment-emergent abnormalities in clinical laboratory parameters [ Time Frame: 28 days ]
    Proportion of patients experiencing treatment-emergent changes in clinical laboratory



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333472


Contacts
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Contact: Zivit Harpaz +972-3-9241114 Zivit@canfite.co.il

Locations
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Israel
Rabin Medical Center
Petah tikva, Israel
Sponsors and Collaborators
Can-Fite BioPharma
Rabin Medical Center
Investigators
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Study Director: Zivit Harpaz Can-Fite BioPharma Ltd
Additional Information:
Publications:
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Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT04333472    
Other Study ID Numbers: CAN-COR-1
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To be determined
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: January 2021, indefinitely
Access Criteria: To be determined

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases