COVID-19Phase 1/2Opaganib-RHBNCT04502069
Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen
A Phase 1/2 study testing Opaganib in people with COVID-19 and Lung Infection, run by RedHill Biopharma Limited at 1 site in Israel.
Trial summary
Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Lung Infection
- What is being tested?
- Opaganib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2020to Jun 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with proven COVID-19 infection diagnosed by nasopharyngeal viral swab who require external oxygen support by high flow nasal cannulas (HFNC) but not mechanical ventilation.
- Pneumonia documented by chest x-ray (CXR)
- The patient or guardian must have signed a written IRB-approved informed consent.
- A negative pregnancy test (if woman of childbearing potential).
- Acceptable liver and renal function:
- Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 2 baseline)
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- AST (SGOT), ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN),
- Serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline)
- Acceptable hematologic status:
- Absolute neutrophil count ≥1000 cells/mm3
- Platelet count ≥75,000 (plt/mm3) (CTCAE Grade 1 baseline)
- Hemoglobin ≥ 9 g/dL
- Clinically acceptable blood sugar control if diabetic
- EKG showing no QTc prolongation
Who cannot join
- Any co-morbidity that that is considered by the treating investigator as an unacceptable risk
- Pregnant or nursing women
- Unwillingness or inability to comply with procedures required in this protocol.
- Caution must be exercised in patients who are receiving drugs that were sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped or replaced with another appropriate medication or not given for the duration of the clinical study. These patients must be discussed with the sponsor in order to determine appropriateness for opaganib therapy.
- Patients who are taking warfarin, apixaban, argatroban or rivaroxaban
- Patients with QTc prolongation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation
Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks).
Read the detailed description
Patients diagnosed with COVID-19 infection by nasopharyngeal viral swab, classified as severe disease, category 5, by the WHO Ordinal Scale For Clinical Improvement (who require oxygen support by high flow nasal cannula but do not require mechanical ventilation) at the time of initiation of therapy will be offered treatment with Opaganib, 500 mg Q12 hours.
Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks), upon voluntary withdrawal is initiated by the patient or when the physician decides that it is not in the patient's best interest to continue.
- Conditions
- COVID-19, Lung Infection
- Being tested
- Opaganib
- Keywords
- Therapeutic Use
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpaganibDrug
500 mg Q12 hours orally
| Study group | Role | What they receive |
|---|---|---|
| Open label opaganib | Experimental | opaganib dosed at 500 mg Q12 hours Receives: Drug: Opaganib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to breathing room air
To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.
Measured: Up to 2 weeks
Adverse Event Grading and Coding
All adverse events will be graded according to the revised NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0). If an AE is not listed in the NCI-CTCAE v.5.0, then the Investigator will use the terms: mild, moderate, severe, life-threatening, or death to describe the maximum intensity of the AE.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: To be replaced with a randomized placebo-controlled study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedHill Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark L Levitt, MD, Study director, RedHill Biopharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502069
- Sponsor's protocol ID
- ABC-112
- Acronym
- Opaganib-RHB
- Status last verified
- Aug 2020
- First submitted
- 10 Jul 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04502069
- Acronym / sponsor ID
- Opaganib-RHB / ABC-112
- Conditions
- COVID-19, Lung Infection
- Keywords
- Therapeutic Use
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: To be replaced with a randomized placebo-controlled study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RedHill Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks).
Detailed description
Patients diagnosed with COVID-19 infection by nasopharyngeal viral swab, classified as severe disease, category 5, by the WHO Ordinal Scale For Clinical Improvement (who require oxygen support by high flow nasal cannula but do not require mechanical ventilation) at the time of initiation of therapy will be offered treatment with Opaganib, 500 mg Q12 hours.
Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks), upon voluntary withdrawal is initiated by the patient or when the physician decides that it is not in the patient's best interest to continue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label opaganib | Experimental | Drug: Opaganibopaganib dosed at 500 mg Q12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with proven COVID-19 infection diagnosed by nasopharyngeal viral swab who require external oxygen support by high flow nasal cannulas (HFNC) but not mechanical ventilation.
- Pneumonia documented by chest x-ray (CXR)
- The patient or guardian must have signed a written IRB-approved informed consent.
- A negative pregnancy test (if woman of childbearing potential).
- Acceptable liver and renal function:
Key exclusion criteria (6 listed)
- Any co-morbidity that that is considered by the treating investigator as an unacceptable risk
- Pregnant or nursing women
- Unwillingness or inability to comply with procedures required in this protocol.
- Caution must be exercised in patients who are receiving drugs that were sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped or replaced with another appropriate medication or not given for the duration of the clinical study. These patients must be discussed with the sponsor in order to determine appropriateness for opaganib therapy.
- Patients who are taking warfarin, apixaban, argatroban or rivaroxaban
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opaganib500 mg Q12 hours orally | Drug | Open label opaganib |
Primary outcome
Time to breathing room air
Time frame: Up to 2 weeks
To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.
Adverse Event Grading and Coding
Time frame: Up to 2 weeks
All adverse events will be graded according to the revised NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0). If an AE is not listed in the NCI-CTCAE v.5.0, then the Investigator will use the terms: mild, moderate, severe, life-threatening, or death to describe the maximum intensity of the AE.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark L Levitt, MD study director
RedHill Biopharma Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Opaganib in people with COVID-19 and Lung Infection, run by RedHill Biopharma Limited at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to breathing room air (time frame: Up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.