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Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen (Opaganib-RHB)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04502069
Recruitment Status : Withdrawn (To be replaced with a randomized placebo-controlled study.)
First Posted : August 6, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited

Tracking Information
First Submitted Date  ICMJE July 10, 2020
First Posted Date  ICMJE August 6, 2020
Last Update Posted Date August 11, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
  • Time to breathing room air [ Time Frame: Up to 2 weeks ]
    To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.
  • Adverse Event Grading and Coding [ Time Frame: Up to 2 weeks ]
    All adverse events will be graded according to the revised NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0). If an AE is not listed in the NCI-CTCAE v.5.0, then the Investigator will use the terms: mild, moderate, severe, life-threatening, or death to describe the maximum intensity of the AE.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen
Official Title  ICMJE Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation
Brief Summary Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks).
Detailed Description

Patients diagnosed with COVID-19 infection by nasopharyngeal viral swab, classified as severe disease, category 5, by the WHO Ordinal Scale For Clinical Improvement (who require oxygen support by high flow nasal cannula but do not require mechanical ventilation) at the time of initiation of therapy will be offered treatment with Opaganib, 500 mg Q12 hours.

Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks), upon voluntary withdrawal is initiated by the patient or when the physician decides that it is not in the patient's best interest to continue.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • Lung Infection
Intervention  ICMJE Drug: Opaganib
500 mg Q12 hours orally
Study Arms  ICMJE Experimental: Open label opaganib
opaganib dosed at 500 mg Q12 hours
Intervention: Drug: Opaganib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 9, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2020)
50
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with proven COVID-19 infection diagnosed by nasopharyngeal viral swab who require external oxygen support by high flow nasal cannulas (HFNC) but not mechanical ventilation.
  2. Pneumonia documented by chest x-ray (CXR)
  3. The patient or guardian must have signed a written IRB-approved informed consent.
  4. A negative pregnancy test (if woman of childbearing potential).
  5. Acceptable liver and renal function:

    1. Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 2 baseline)
    2. AST (SGOT), ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN),
    3. Serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline)
  6. Acceptable hematologic status:

    1. Absolute neutrophil count ≥1000 cells/mm3
    2. Platelet count ≥75,000 (plt/mm3) (CTCAE Grade 1 baseline)
    3. Hemoglobin ≥ 9 g/dL
  7. Clinically acceptable blood sugar control if diabetic
  8. EKG showing no QTc prolongation

Exclusion Criteria:

  1. Any co-morbidity that that is considered by the treating investigator as an unacceptable risk
  2. Pregnant or nursing women
  3. Unwillingness or inability to comply with procedures required in this protocol.
  4. Caution must be exercised in patients who are receiving drugs that were sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped or replaced with another appropriate medication or not given for the duration of the clinical study. These patients must be discussed with the sponsor in order to determine appropriateness for opaganib therapy.
  5. Patients who are taking warfarin, apixaban, argatroban or rivaroxaban
  6. Patients with QTc prolongation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04502069
Other Study ID Numbers  ICMJE ABC-112
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party RedHill Biopharma Limited
Study Sponsor  ICMJE RedHill Biopharma Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark L Levitt, MD RedHill Biopharma Limited
PRS Account RedHill Biopharma Limited
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP