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Trial record 4 of 57 for:    redhill

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Recruitment Status : Withdrawn (To be replaced with a randomized placebo-controlled study.)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

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).

Condition or disease Intervention/treatment Phase
COVID-19 Lung Infection Drug: Opaganib Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Open label opaganib
opaganib dosed at 500 mg Q12 hours
Drug: Opaganib
500 mg Q12 hours orally




Primary Outcome Measures :
  1. 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.

  2. 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.



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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. 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

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): NCT04502069


Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
RedHill Biopharma Limited
Investigators
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Study Director: Mark L Levitt, MD RedHill Biopharma Limited
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Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT04502069    
Other Study ID Numbers: ABC-112
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by RedHill Biopharma Limited:
Therapeutic Use
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections