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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: COVID-19; Lung Infection
• Intervention / Treatment: Drug: Opaganib

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: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open label opaganib; opaganib dosed at 500 mg Q12 hours	Drug: Opaganib; 500 mg Q12 hours orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to breathing room air	To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.	Up to 2 weeks
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.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: RedHill Biopharma Limited
• Investigators: Study Director: Mark L Levitt, MD, RedHill Biopharma Limited

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Therapeutic Use
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: ABC-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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