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

Primary Purpose

COVID-19, Lung Infection

Status

Withdrawn

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Opaganib

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Therapeutic Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Pneumonia documented by chest x-ray (CXR)
The patient or guardian must have signed a written IRB-approved informed consent.
A negative pregnancy test (if woman of childbearing potential).
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)
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
Clinically acceptable blood sugar control if diabetic
EKG showing no QTc prolongation

Exclusion Criteria:

Any co-morbidity that that is considered by the treating investigator as an unacceptable risk
Pregnant or nursing women
Unwillingness or inability to comply with procedures required in this protocol.
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.
Patients who are taking warfarin, apixaban, argatroban or rivaroxaban
Patients with QTc prolongation

Sites / Locations

Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label opaganib

Arm Description

opaganib dosed at 500 mg Q12 hours

Outcomes

Primary Outcome Measures

Time to breathing room air

To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.

Adverse Event Grading and Coding

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04502069

First Posted

July 10, 2020

Last Updated

August 9, 2020

Sponsor

RedHill Biopharma Limited

1. Study Identification

Unique Protocol Identification Number

NCT04502069

Brief Title

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

Acronym

Opaganib-RHB

Official Title

Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Withdrawn

Why Stopped

To be replaced with a randomized placebo-controlled study.

Study Start Date

August 2020 (Anticipated)

Primary Completion Date

February 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RedHill Biopharma Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Lung Infection

Keywords

Therapeutic Use

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open label opaganib

Arm Type

Experimental

Arm Description

opaganib dosed at 500 mg Q12 hours

Intervention Type

Drug

Intervention Name(s)

Opaganib

Intervention Description

500 mg Q12 hours orally

Primary Outcome Measure Information:

Title

Time to breathing room air

Description

To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.

Time Frame

Up to 2 weeks

Title

Adverse Event Grading and Coding

Description

Time Frame

Up to 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Pneumonia documented by chest x-ray (CXR) The patient or guardian must have signed a written IRB-approved informed consent. A negative pregnancy test (if woman of childbearing potential). Acceptable liver and renal function: Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 2 baseline) AST (SGOT), ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN), Serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline) Acceptable hematologic status: Absolute neutrophil count ≥1000 cells/mm3 Platelet count ≥75,000 (plt/mm3) (CTCAE Grade 1 baseline) Hemoglobin ≥ 9 g/dL Clinically acceptable blood sugar control if diabetic EKG showing no QTc prolongation Exclusion Criteria: Any co-morbidity that that is considered by the treating investigator as an unacceptable risk Pregnant or nursing women Unwillingness or inability to comply with procedures required in this protocol. 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. Patients who are taking warfarin, apixaban, argatroban or rivaroxaban Patients with QTc prolongation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark L Levitt, MD

Organizational Affiliation

RedHill Biopharma Limited

Official's Role

Study Director

Facility Information:

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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