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

Completed

• Conditions: Coronavirus Infections
• Interventions: Drug: Opaganib; Drug: Standard of Care

• Registration Number: NCT04435106
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2020-04-03
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-15
• Study First Submitted: 2020-05-26
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-16
• Last Update Submitted: 2020-06-16
• Study First Posted: 2020-06-17
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Shaare-Zedek Medical Center; 🇮🇱 Jerusalem, Israel