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

NCT04502069 | Withdrawn Phase 1

• 1 other identifier: ABC-112
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19; Lung Infection

Keywords

Therapeutic Use

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Open label opaganib

EXPERIMENTAL

opaganib dosed at 500 mg Q12 hours

Drug: Opaganib

Interventions

Opaganib DRUG

500 mg Q12 hours orally

Open label opaganib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RedHill Biopharma Limited: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

COVID-19

Interventions

3-(4-chlorophenyl)-adamantane-1-carboxylic acid (pyridin-4-ylmethyl)amide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mark L Levitt, MD

  RedHill Biopharma Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: August 6, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)