An Expanded Access Program Allowing Compassionate Use of Opaganib for Patients with Confirmed SARS-CoV-2 Infection with Life-Threatening Manifestations
Latest Information Update: 20 Apr 2020
At a glance
- Drugs Opaganib (Primary)
- Indications COVID 2019 infections
- Focus Expanded access; Therapeutic Use
- 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
Most Recent Events
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
-
RedHill Biopharma. Additional Update on COVID-19 Compassionate Use with Opaganib in Israel Provided by RedHill Biopharma. Media-Rel 2020;.
Media Release
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
-
RedHill Biopharma. RedHill Biopharma Announces Approval of Compassionate Use of Opaganib for COVID-19 in Italy. Media-Rel 2020;.
Media Release -
RedHill Biopharma. RedHill Biopharma Provides Initial Update from its Opaganib COVID-19 Compassionate Use Program in Israel. Media-Rel 2020;.
Media Release -
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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