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Completed

NCT Number: NCT04435106

Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (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.

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Key information

Conditions

Coronavirus Infections Coronaviridae Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shaare-Zedek Medical Center

Jerusalem, 9103102, Israel

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opaganib

Drug

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

Other names: Yeliva, ABC294640

Standard of care

Drug

Study participants received Standard of Care

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

Compassionate Use of Opaganib in Patients With Severe COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 17, 2020
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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