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

Coronavirus Infections Clinical Trial

Official title:

Compassionate Use of Opaganib in Patients With Severe COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435106
• Other study ID #: 0123-20- SZMC
• Status: Completed
• Start date: April 3, 2020
• Est. completion date: May 15, 2020

Study information

• Verified date: June 2020
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 15, 2020
• Est. primary completion date: May 1, 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Israel	Shaare-Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the time to weaning from high-flow nasal cannula		Every day from day 1 to day 14
Primary	Measure the time to breathing ambient (room) air		Every day from day 1 to day 14
Secondary	Measure change in lymphocyte count		On day of admission or day 1 of treatment and every 2-4 days, till day 14
Secondary	Measure change in C-reactive protein		On day of admission or day 1 of treatment and every 2-4 days, till day 14