Coronavirus Infections Clinical Trial
Official title:
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.
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.
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