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Compassionate Use of Opaganib in Patients With Severe COVID-19

Trial Profile

Compassionate Use of Opaganib in Patients With Severe COVID-19

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 24 Jun 2020

At a glance

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

    • 24 Jun 2020 According to a RedHill Biopharma media release, results from the study have been published in medRxiv.
    • 24 Jun 2020 Results (n=5) presented in a RedHill Biopharma media release.
    • 27 Apr 2020 Preliminary results (n=6) published in the RedHill Biopharma Media Release

Trial Overview

Purpose

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.

Primary Endpoints

Measure the time to weaning from high-flow nasal cannula

time_frame: Every day from day 1 to day 14

Measure the time to breathing ambient (room) air

time_frame: Every day from day 1 to day 14

Other Endpoints

Measure change in lymphocyte count

time_frame: On day of admission or day 1 of treatment and every 2-4 days, till day 14

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 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 23

  • Sex male & female
  • Age Group 18-80 years; adult; elderly

Patient 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04435106 ClinicalTrials.gov: US National Institutes of Health
0123-20SZMC -

Organisations

  • Sponsors RedHill Biopharma
  • Affiliations RedHill Biopharma

Trial Dates

  • Initiation Dates

    Actual : 03 Apr 2020

  • Primary Completion Dates

    Actual : 01 May 2020

  • End Dates

    Actual : 15 May 2020

Other Details

  • Design case control; observational; retrospective
  • Phase of Trial Clinical Phase Unknown
  • Location Israel
  • Focus Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
OpaganibPrimary Drug Oral Capsule

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 Name: 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)

Results

Therapeutic efficacy

Results from the first five patients with severe COVID-19 infections showed substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared with a matched case-control group (n=18) from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air, without having required mechanical ventilation, whereas 33% of patients in the control group required mechanical ventilation. The median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the control group. Improvement in lymphocyte counts was faster in opaganib-treated patients as compared with patients in the control group. The C-reactive protein showed faster improvement in the opaganib treated group as compared to the control group [2] . 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 [3] [4] .

Adverse events

In the first five patients with severe COVID-19 infections (compassionate use), the treatment with opaganib was found to be safe and well tolerated. An improvement in clinical and laboratory parameters was demonstrated for opaganib-treated patients compared to matched case-controls [2] . Adverse events data obtained from a clinical 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 [4] .

Publications

  1. RedHill Biopharma. Publication of Data from Severe COVID-19 Patients Shows Substantial Benefit to Patients Treated with RedHills Opaganib Compared to Matched Case-Control Group. 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 Provides Initial Update from its Opaganib COVID-19 Compassionate Use Program in Israel. 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

Authors

Author Total Publications First Author Last Author
RedHill Biopharma 4 4 4

Trial Centres

Centres

Centre Name Location Trial Centre Country
RedHill Biopharma
-
-

Trial History

Event Date Event Type Comment
24 Jun 2020 Results According to a RedHill Biopharma media release, results from the study have been published in medRxiv. Updated 01 Jul 2020
24 Jun 2020 Results Results (n=5) presented in a RedHill Biopharma media release. Updated 01 Jul 2020
24 Jun 2020 Other trial event New source identified and integrated(ClinicalTrials.gov: US National Institutes of Health;NCT04435106). Updated 24 Jun 2020
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. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. RedHill Biopharma. Publication of Data from Severe COVID-19 Patients Shows Substantial Benefit to Patients Treated with RedHills Opaganib Compared to Matched Case-Control Group. Media-Rel 2020;.

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

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

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

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

    Media Release
  7. 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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