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A trial assessing Opaganib for COVID-19 in Hospitalized patients suffered from moderate-to-severe acute respiratory symptoms related to SARS-CoV-2 infection

Trial Profile

A trial assessing Opaganib for COVID-19 in Hospitalized patients suffered from moderate-to-severe acute respiratory symptoms related to SARS-CoV-2 infection

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Apr 2020

At a glance

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

    • 27 Apr 2020 Preliminary results (n=6) published in the RedHill Biopharma Media Release
    • 17 Apr 2020 Results published in the Media Release
    • 17 Apr 2020 According to a RedHill Biopharma media release, five patients has been treated in this trial.

Trial Overview

Purpose

This trial is assessing Opaganib for COVID-19 in Hospitalized patients suffered from moderate-to-severe acute respiratory symptoms related to SARS-CoV-2 infection.

Other Endpoints

−Clinical improvement within days of treatment initiation, including supplemental oxygen requirements, C-reactive protein (CRP) levels and increased lymphocyte levels [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Sex male & female

Patient Inclusion Criteria

−Patients with COVID-19 infection.

Trial Details

Organisations

  • Sponsors RedHill Biopharma
  • Affiliations RedHill Biopharma

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Phase II
  • Location Israel
  • Focus Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
OpaganibPrimary Drug Oral
-

Opaganib plus standard-of-care, including hydroxychloroquine background therapy

Opaganib administered in addition to standard-of-care, including hydroxychloroquine background therapy

Results

Therapeutic efficacy

Updated efficacy data obtained from a clinical trial in Israel in six of the COVID-19 patients showed significant improvements following treatment with opaganib with and without hydroxychloroquine including decreased supplemental oxygen requirements, decreased C-reactive protein levels and increased lymphocyte levels. Five of the six patients analysed were weaned from oxygen, and three patients were discharged from the hospital within days of treatment initiation [2] [1] .

Adverse events

Adverse events data obtained from a clinial trial in Israel in two of the COVID-19 patients indicated that at doses administered, opaginib was found to be well tolerated with no treatment emergent adverse events [1] .

Publications

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

    Media Release
  2. RedHill Biopharma. Six COVID-19 Patients Treated with RedHills Opaganib Under Compassionate Use Show Objective Clinical Improvement. 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

Authors

Author Total Publications First Author Last Author
RedHill Biopharma 3 3 3

Trial Centres

Centres

Centre Name Location Trial Centre Country
RedHill Biopharma
-
-

Trial History

Event Date Event Type Comment
27 Apr 2020 Interim results Preliminary results (n=6) published in the RedHill Biopharma Media Release Updated 13 May 2020
17 Apr 2020 Results Results published in the Media Release Updated 20 Apr 2020
17 Apr 2020 Other trial event According to a RedHill Biopharma media release, five patients has been treated in this trial. Updated 20 Apr 2020
13 Apr 2020 Interim results Preliminary results (n=2) presented in a RedHill Biopharma media release. 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, this compassionate use is approved by Israeli Ministry of Health. Additional patients expected to be treated in the coming days. Updated 08 Apr 2020
06 Apr 2020 Other trial event According to a REdhill Biopharma media release, the company announced that the first patient with confirmed coronavirus (COVID-19) diagnosis has been dosed at a leading hospital in Israel. Updated 08 Apr 2020

References

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

    Media Release
  2. RedHill Biopharma. Six COVID-19 Patients Treated with RedHills Opaganib Under Compassionate Use Show Objective Clinical Improvement. Media-Rel 2020;.

    Media Release
  3. RedHill Biopharma. RedHill Biopharma Announces First COVID-19 Patient Treated with Opaganib in Israel Under Compassionate Use. Media-Rel 2020;.

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

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

    Media Release
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