Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (COVID-19)

Compassionate Use of Opaganib in Patients With Severe COVID-19

Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infections
• Intervention / Treatment: Drug: Opaganib; Drug: Standard of Care

Detailed Description

In this observational study, the two cohorts were assigned retrospectively. Patients either received opaganib and Standard of Care (SOC) or SOC only. All patients were defined by the treating physicians at baseline as severe COVID-19. For the control cohort, IRB approval was granted to collect de-identified data. Both cohorts had similar median age and similar rates of diabetes, hypertension and obesity.

The two treatment groups, opaganib and SOC vs. SOC were then analyzed for their clinical outcomes including baseline characteristics.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 9103102
    • Shaare-Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe COVID-19 who required oxygen support via high-flow nasal cannula (HFNC)

Description

Inclusion Criteria:

• hospitalized patients with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay
• patients with severe disease requiring oxygen support via high-flow nasal cannula
• signed informed consent
• acceptable liver and renal function tests
• acceptable hematologic status

Exclusion Criteria:

• pregnant or nursing women
• patients on warfarin, apixaban, argatroban or rivaroxaban
• patients with New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Opaganib + Standard of Care; Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care	Drug: Opaganib; Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care; Other Names: Yeliva; ABC294640; Drug: Standard of Care; Study participants received Standard of Care
Standard of Care; Study participants received Standard of Care	Drug: Standard of Care; Study participants received Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure the time to weaning from high-flow nasal cannula	Every day from day 1 to day 14
Measure the time to breathing ambient (room) air	Every day from day 1 to day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure change in lymphocyte count	On day of admission or day 1 of treatment and every 2-4 days, till day 14
Measure change in C-reactive protein	On day of admission or day 1 of treatment and every 2-4 days, till day 14

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2020
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: 0123-20- SZMC