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

Shaare Zedek Medical Center

Status: Completed

Conditions: Coronavirus Infections

Treatments: Drug: Standard of Care; Drug: Opaganib

Study type: Observational

Funder types: Other

Identifiers

NCT04435106

0123-20- SZMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

23 participants in 2 patient groups

Opaganib + Standard of Care

Description:

Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care

Treatment:

Drug: Opaganib

Drug: Standard of Care

Standard of Care

Description:

Study participants received Standard of Care

Treatment:

Drug: Standard of Care