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

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ClinicalTrials.gov Identifier: NCT04435106
Recruitment Status : Completed
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Coronavirus Infections Drug: Opaganib Drug: Standard of Care

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.

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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 : April 3, 2020
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Measure the time to weaning from high-flow nasal cannula [ Time Frame: Every day from day 1 to day 14 ]
  2. Measure the time to breathing ambient (room) air [ Time Frame: Every day from day 1 to day 14 ]

Secondary Outcome Measures :
  1. Measure change in lymphocyte count [ Time Frame: On day of admission or day 1 of treatment and every 2-4 days, till day 14 ]
  2. Measure change in C-reactive protein [ Time Frame: On day of admission or day 1 of treatment and every 2-4 days, till day 14 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe COVID-19 who required oxygen support via high-flow nasal cannula (HFNC)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435106


Locations
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Israel
Shaare-Zedek Medical Center
Jerusalem, Israel, 9103102
Sponsors and Collaborators
Shaare Zedek Medical Center
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Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT04435106    
Other Study ID Numbers: 0123-20- SZMC
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases