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An Expanded Access Program Allowing Compassionate Use of Opaganib for Patients with Confirmed SARS-CoV-2 Infection with Life-Threatening Manifestations

Trial Profile

An Expanded Access Program Allowing Compassionate Use of Opaganib for Patients with Confirmed SARS-CoV-2 Infection with Life-Threatening Manifestations

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 17 Apr 2020

At a glance

  • Drugs Opaganib (Primary)
  • Indications COVID 2019 infections
  • Focus Expanded access; Therapeutic Use
  • Most Recent Events

    • 17 Apr 2020 According to a RedHill Biopharma media release, the company is planning to convert this compassionate use program to a clinical study in order to generate more robust clinical data in a controlled setting for regulatory purposes.
    • 13 Apr 2020 According to a RedHill Biopharma media release, patients are planned to be treated in three major hospitals in northern Italy under an expanded access program approved by the Italian National Institute for Infectious Diseases, allowing compassionate use of opaganib, for patients with confirmed SARS-CoV-2 infection with life-threatening manifestations.
    • 08 Apr 2020 New trial record

Trial Overview

Purpose

This expanded access program is allowing compassionate use of Opaganib for patients with confirmed SARS-CoV-2 infection with life-threatening manifestations.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 160

  • Sex male & female

Patient Inclusion Criteria

−Patients with confirmed SARS-CoV-2 infection with life-threatening manifestations.

Trial Details

Organisations

  • Affiliations RedHill Biopharma

Trial Dates

Other Details

  • Design multicentre; prospective
  • Phase of Trial Clinical Phase Unknown
  • Location Italy
  • Focus Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
OpaganibPrimary Drug Oral
-

Opaganib

Results

Publications

  1. RedHill Biopharma. Additional Update on COVID-19 Compassionate Use with Opaganib in Israel Provided by RedHill Biopharma. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
RedHill Biopharma 1 1 1

Trial History

Event Date Event Type Comment
17 Apr 2020 Other trial event According to a RedHill Biopharma media release, the company is planning to convert this compassionate use program to a clinical study in order to generate more robust clinical data in a controlled setting for regulatory purposes. Updated 20 Apr 2020
13 Apr 2020 Other trial event According to a RedHill Biopharma media release, patients are planned to be treated in three major hospitals in northern Italy under an expanded access program approved by the Italian National Institute for Infectious Diseases, allowing compassionate use of opaganib, for patients with confirmed SARS-CoV-2 infection with life-threatening manifestations. Updated 20 Apr 2020
08 Apr 2020 New trial record New trial record Updated 08 Apr 2020
06 Apr 2020 Other trial event According to a RedHill Biopharma media release, authorization of compassionate use granted by the Italian authorities, aided by RedHill strategic partner, Cosmo Pharmaceuticals N.V. Updated 08 Apr 2020

References

  1. RedHill Biopharma. RedHill Biopharma Announces Approval of Compassionate Use of Opaganib for COVID-19 in Italy. Media-Rel 2020;.

    Media Release
  2. RedHill Biopharma. RedHill Biopharma Provides Initial Update from its Opaganib COVID-19 Compassionate Use Program in Israel. Media-Rel 2020;.

    Media Release
  3. RedHill Biopharma. Additional Update on COVID-19 Compassionate Use with Opaganib in Israel Provided by RedHill Biopharma. Media-Rel 2020;.

    Media Release
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