Coronavirus InfectionsPhase 2COVID-19NCT04414618
A Study of Opaganib in Coronavirus Disease 2019 Pneumonia
A Phase 2 study testing Opaganib in people with Coronavirus Infections, run by RedHill Biopharma Limited at 9 sites in 2 countries.
Trial summary
This proof of concept study will take place in the US and other countries in approximately 15 clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronavirus Infections
- What is being tested?
- Opaganib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 2 Jul 2020to 23 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female ≥18 to ≤80 years of age
- Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray
- The patient requires supplemental oxygen at baseline
- The patient, guardian or legal representative has signed a written IRB-approved informed consent.
- 5) Male participants with female partners of child-bearing potential agree to one of the following methods of contraception during the treatment period and for at least 1 month after the last dose of study drug:
- Abstinence from penile-vaginal intercourse and agree to remain abstinent.
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- Male condom, with female partner using a highly effective contraceptive method. (For further details regarding highly effective contraceptive methods please see section 9.3.)
- In addition, male participants must refrain from donating sperm for the duration of the study and for 1 months after last dose of study drug.
- Male participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration for at least 1 months after the last dose of study drug
- Female participants:
- A female participant is eligible to participate if she is:
- not pregnant
- not breastfeeding
- not a woman of child-bearing potential (WOCBP, as defined in Section 9.3)
- a WOCBP who agrees to use a highly effective method of contraception consistently and correctly during the treatment period and for at least 1 months after the last dose of study drug (please see further details on Section 9.3).
Who cannot join
- Any co-morbidity that may add risk to the treatment in the judgement of the investigator.
- Requiring intubation and mechanical ventilation
- Patient having a do not intubate or do not resuscitate order
- Oxygen saturation >95% on room air
- Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
- Patient is, in the investigator's clinical judgment, unlikely to survive >72 hours
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- Pregnant or nursing women
- Unwillingness or inability to comply with procedures required in this protocol.
- Corrected QT (QTc) interval on electrocardiogram (ECG) >470 ms for females or >450 ms for males, calculated using Friedericia's formula (QTcF)
- AST (SGOT) or ALT (SGPT) > 2.5 x upper limit of normal (ULN)
- Bilirubin >2.0 x ULN (except where bilirubin increase is due to Gilbert's Syndrome)
- Serum creatinine >2.0 X ULN
- Absolute neutrophil count <1000 cells/mm3
- Platelet count <75,000/mm3
- Hemoglobin <8.0 g/dL
- Currently taking medications that are sensitive CYP3A4, CYP1A2, CYP2C9, or CYP2C19 or CYP2D6 substrates and have a narrow therapeutic index. These should be decided in discussion with the Medical Monitor on a case-by-case basis.
- Currently taking medications that are strong inducers or inhibitors of CYP2D6 and CYP3A4. These should be decided in discussion with the Medical Monitor on a case-by-case basis.
- Currently taking warfarin, apixaban, argatroban or rivaroxaban.
- Current drug or alcohol abuse.
- Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Albany Medical Center
Albany, New York, 12208
Henry Ford Hospital
Detroit, Michigan, 48202
Ascension St. John Hospital
Detroit, Michigan, 48236
Memorial Herman Southeast Hospital
Houston, Texas, 77089
Memorial Hermann, Memorial City Medical Center
Houston, Texas, 77204
Miami Cancer Institute
Miami, Florida, 33176
Oregon Health & Science University
Portland, Oregon, 97239
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2a Study, in Adult Subjects Hospitalized With SARS-CoV-2 Positive Pneumonia
This proof of concept study will take place in the US and other countries in approximately 15 clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. 20 patients will receive opaganib in addition to standard of care twice each day for 14 days. 20 will receive matching placebo in addition to standard of care unless the patient has been discharged from the hospital without requiring supplemental oxygen, in which case study drug will only be administered for 10 days. All participants will be followed up for 4 weeks after their last dose of study drug.
Read the detailed description
Opaganib, a sphingosine kinase-2 (SphK2) inhibitor, has been broadly tested in Phase I/II studies. Extensive nonclinical data indicates both anti-viral and anti-inflammatory activity via selective SphK2 inhibition which may prove beneficial for treating COVID-19 infection and resulting pneumonia. This proof of concept study will take place in the US and other countries and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. Half of the patients, i.e. 20 patients, will receive opaganib in addition to standard of care for 14 days. The other 20 will receive matching placebo (capsules that do not contain the medication) in addition to standard of care. Study drug will be administered every day for 14 days, twice each day, unless the patient has been discharged from the hospital without requiring supplemental oxygen, in which case study drug will only be administered for 10 days. All participants will be followed up for 4 weeks after their last dose of study drug.
- Conditions
- Coronavirus Infections
- Being tested
- Opaganib, Placebo
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpaganibDrug
Also called Yeliva, ABC294640
Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
PlaceboDrug
Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
| Study group | Role | What they receive |
|---|---|---|
| opaganib | Active comparator | Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours Receives: Drug: Opaganib |
| placebo | Placebo comparator | Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the Change in Oxygen Requirement From Baseline
Maximal oxygen flow (L/min) was recorded daily for the 14 days of treatment for each participant. Participant individual area under the curve (AUC) was calculated based on the trapezoidal rule, after subtracting the baseline oxygen requirement at each day. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.
Measured: 14 days
Secondary outcomes (8)
Measurement of Time to the Reduction in Oxygen Requirement.
The time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min.
Measured: 14 days
The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14
The percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14.
Measured: 14 days
Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment
The time in each arm to two consecutive negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab, at least 24 hrs. apart.
Measured: 6 weeks
The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14
The percentage of subjects in each arm to achieve two consecutive negative PCR nasopharyngeal or oropharyngeal swabs for SARS-CoV-2 at Day 14, at least 24 hrs. apart.
Measured: 14 days
Intubation and Mechanical Ventilation Requirements
The percentage of patients in each arm who require intubation and mechanical ventilation by Day 14
Measured: From screening phase and every day from day 1 to day 14 of treatment
Evaluation of the Time to Intubation and Mechanical Ventilation
The time in each arm for the patient to require mechanical ventilation.
Measured: From screening phase and every day from day 1 to day 14 of treatment
Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14
The proportion of patients in each arm, with at least one measurement of fever at baseline (defined as temperature >38.0 C[100.4 F]), who are afebrile (defined as temperature <37.2C [99 F]) at Day 14
Measured: From screening phase and every day from day 1 to day 14 of treatment
Evaluation of Mortality 30 Days Post-baseline
The mortality in each arm 30 days post-baseline.
Measured: 30 days after day 1 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start2 Jul 2020
- Primary completion26 Nov 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronavirus InfectionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedHill Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark L Levitt, MD, PhD, Study director, RedHill Biopharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414618
- Sponsor's protocol ID
- ABC-110
- Acronym
- COVID-19
- Status last verified
- Mar 2022
- First submitted
- 26 May 2020
- Last updated
- 21 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2a Study, in Adult Subjects Hospitalized With SARS-CoV-2 Positive Pneumonia
- ClinicalTrials.gov ID
- NCT04414618
- Acronym / sponsor ID
- COVID-19 / ABC-110
- Conditions
- Coronavirus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- RedHill Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 21 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proof of concept study will take place in the US and other countries in approximately 15 clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. 20 patients will receive opaganib in addition to standard of care twice each day for 14 days. 20 will receive matching placebo in addition to standard of care unless the patient has been discharged from the hospital without requiring supplemental oxygen, in which case study drug will only be administered for 10 days. All participants will be followed up for 4 weeks after their last dose of study drug.
Detailed description
Opaganib, a sphingosine kinase-2 (SphK2) inhibitor, has been broadly tested in Phase I/II studies. Extensive nonclinical data indicates both anti-viral and anti-inflammatory activity via selective SphK2 inhibition which may prove beneficial for treating COVID-19 infection and resulting pneumonia. This proof of concept study will take place in the US and other countries and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. Half of the patients, i.e. 20 patients, will receive opaganib in addition to standard of care for 14 days. The other 20 will receive matching placebo (capsules that do not contain the medication) in addition to standard of care. Study drug will be administered every day for 14 days, twice each day, unless the patient has been discharged from the hospital without requiring supplemental oxygen, in which case study drug will only be administered for 10 days. All participants will be followed up for 4 weeks after their last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opaganib | Active comparator | Drug: OpaganibStudy participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours |
| placebo | Placebo comparator | Drug: PlaceboStudy participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult male or female ≥18 to ≤80 years of age
- Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray
- The patient requires supplemental oxygen at baseline
- The patient, guardian or legal representative has signed a written IRB-approved informed consent.
- 5) Male participants with female partners of child-bearing potential agree to one of the following methods of contraception during the treatment period and for at least 1 month after the last dose of study drug:
Key exclusion criteria (20 listed)
- Any co-morbidity that may add risk to the treatment in the judgement of the investigator.
- Requiring intubation and mechanical ventilation
- Patient having a do not intubate or do not resuscitate order
- Oxygen saturation >95% on room air
- Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
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 |
|---|---|---|
| OpaganibAlso: Yeliva, ABC294640Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive). | Drug | opaganib |
| PlaceboStudy participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive). | Drug | placebo |
Primary outcome
Measurement of the Change in Oxygen Requirement From Baseline
Time frame: 14 days
Maximal oxygen flow (L/min) was recorded daily for the 14 days of treatment for each participant. Participant individual area under the curve (AUC) was calculated based on the trapezoidal rule, after subtracting the baseline oxygen requirement at each day. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.
8 secondary outcomes
Measurement of Time to the Reduction in Oxygen Requirement.
Time frame: 14 days
The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14
Time frame: 14 days
Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment
Time frame: 6 weeks
The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14
Time frame: 14 days
Intubation and Mechanical Ventilation Requirements
Time frame: From screening phase and every day from day 1 to day 14 of treatment
Evaluation of the Time to Intubation and Mechanical Ventilation
Time frame: From screening phase and every day from day 1 to day 14 of treatment
Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14
Time frame: From screening phase and every day from day 1 to day 14 of treatment
Evaluation of Mortality 30 Days Post-baseline
Time frame: 30 days after day 1 of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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, PhD study director
RedHill Biopharma Limited
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Opaganib in people with Coronavirus Infections, run by RedHill Biopharma Limited at 9 sites in 2 countries.
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 15 inclusion and 20 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: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 21 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of the Change in Oxygen Requirement From Baseline (time frame: 14 days). 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 21 Mar 2022.