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

Sponsor
Shaare Zedek Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04435106
Collaborator
(none)
23
Enrollment
1
Location
1.4
Actual Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
23 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Compassionate Use of Opaganib in Patients With Severe COVID-19
Actual Study Start Date :
Apr 3, 2020
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
May 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Opaganib + Standard of Care

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

Drug: Opaganib
Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care
Other Names:
  • Yeliva
  • ABC294640

    • Drug: Standard of Care
    Study participants received Standard of Care
    Standard of Care

    Study participants received Standard of Care

    Drug: Standard of Care
    Study participants received Standard of Care

    Outcome Measures

    Primary Outcome Measures

    1. Measure the time to weaning from high-flow nasal cannula [Every day from day 1 to day 14]

    2. Measure the time to breathing ambient (room) air [Every day from day 1 to day 14]

    Secondary Outcome Measures

    1. Measure change in lymphocyte count [On day of admission or day 1 of treatment and every 2-4 days, till day 14]

    2. Measure change in C-reactive protein [On day of admission or day 1 of treatment and every 2-4 days, till day 14]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shaare-Zedek Medical Center Jerusalem Israel 9103102

    Sponsors and Collaborators

    • Shaare Zedek Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shaare Zedek Medical Center
    ClinicalTrials.gov Identifier:
    NCT04435106
    Other Study ID Numbers:
    • 0123-20- SZMC
    First Posted:
    Jun 17, 2020
    Last Update Posted:
    Jun 17, 2020
    Last Verified:
    Jun 1, 2020
    Additional relevant MeSH terms:
    Coronavirus Infections

    Study Results

    No Results Posted as of Jun 17, 2020