- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414618
A Study of Opaganib in Coronavirus Disease 2019 Pneumonia (COVID-19)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Safed, Israel
- Ziv Medical Center
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Arizona
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Scottsdale, Arizona, United States, 85258
- HonorHealth Research Institute
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Florida
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Miami, Florida, United States, 33176
- Miami Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Detroit, Michigan, United States, 48236
- Ascension St. John Hospital
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New York
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Albany, New York, United States, 12208
- Albany Medical Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Texas
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Houston, Texas, United States, 77089
- Memorial Herman Southeast Hospital
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Houston, Texas, United States, 77204
- Memorial Hermann, Memorial City Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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).
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: opaganib
Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours
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Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
Other Names:
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Placebo Comparator: placebo
Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours
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Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of the Change in Oxygen Requirement From Baseline
Time Frame: 14 days
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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.
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14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Time to the Reduction in Oxygen Requirement.
Time Frame: 14 days
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The time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min.
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14 days
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The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14
Time Frame: 14 days
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The percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14.
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14 days
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Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment
Time Frame: 6 weeks
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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.
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6 weeks
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The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14
Time Frame: 14 days
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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.
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14 days
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Intubation and Mechanical Ventilation Requirements
Time Frame: From screening phase and every day from day 1 to day 14 of treatment
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The percentage of patients in each arm who require intubation and mechanical ventilation by Day 14
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From screening phase and every day from day 1 to day 14 of treatment
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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
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The time in each arm for the patient to require mechanical ventilation.
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From screening phase and every day from day 1 to day 14 of treatment
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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
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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
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From screening phase and every day from day 1 to day 14 of treatment
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Evaluation of Mortality 30 Days Post-baseline
Time Frame: 30 days after day 1 of treatment
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The mortality in each arm 30 days post-baseline.
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30 days after day 1 of treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety TEAEs
Time Frame: 6 weeks
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The number of subjects with treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs).
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6 weeks
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Safety SAEs
Time Frame: 6 weeks
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The number of subjects with serious adverse events (SAEs) in each arm.
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mark L Levitt, MD, PhD, RedHill Biopharma Limited
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABC-110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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