Clinical trial NCT04435106: Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (COVID-19)
Official title: Compassionate Use of Opaganib in Patients With Severe COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infections
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe COVID-19 who required oxygen support via high-flow nasal cannula (HFNC)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure the time to weaning from high-flow nasal cannula
timeFrame: Every day from day 1 to day 14
measure: Measure the time to breathing ambient (room) air
timeFrame: Every day from day 1 to day 14
Secondary outcomes:
measure: Measure change in lymphocyte count
timeFrame: On day of admission or day 1 of treatment and every 2-4 days, till day 14
measure: Measure change in C-reactive protein
timeFrame: On day of admission or day 1 of treatment and every 2-4 days, till day 14
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare-Zedek Medical Center
Study officials:
References: