A Study of Opaganib in Coronavirus Disease 2019 Pneumonia (COVID-19)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04414618 |
Recruitment Status :
Completed
First Posted : June 4, 2020
Results First Posted : March 21, 2022
Last Update Posted : March 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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Coronavirus Infections | Drug: Opaganib Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 2, 2020 |
Actual Primary Completion Date : | November 26, 2020 |
Actual Study Completion Date : | December 23, 2020 |

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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Drug: Opaganib
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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Drug: Placebo
Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive). |
- 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.
- Measurement of Time to the Reduction in Oxygen Requirement. [ Time Frame: 14 days ]The time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min.
- The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14 [ Time Frame: 14 days ]The percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14.
- Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment [ Time Frame: 6 weeks ]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.
- The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14 [ Time Frame: 14 days ]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.
- Intubation and Mechanical Ventilation Requirements [ Time Frame: From screening phase and every day from day 1 to day 14 of treatment ]The percentage of patients in each arm who require intubation and mechanical ventilation by Day 14
- 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 ]The time in each arm for the patient to require mechanical ventilation.
- 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 ]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
- Evaluation of Mortality 30 Days Post-baseline [ Time Frame: 30 days after day 1 of treatment ]The mortality in each arm 30 days post-baseline.
- Safety TEAEs [ Time Frame: 6 weeks ]The number of subjects with treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs).
- Safety SAEs [ Time Frame: 6 weeks ]The number of subjects with serious adverse events (SAEs) in each arm.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414618
United States, Arizona | |
HonorHealth Research Institute | |
Scottsdale, Arizona, United States, 85258 | |
United States, Florida | |
Miami Cancer Institute | |
Miami, Florida, United States, 33176 | |
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
Ascension St. John Hospital | |
Detroit, Michigan, United States, 48236 | |
United States, New York | |
Albany Medical Center | |
Albany, New York, United States, 12208 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
Memorial Herman Southeast Hospital | |
Houston, Texas, United States, 77089 | |
Memorial Hermann, Memorial City Medical Center | |
Houston, Texas, United States, 77204 | |
Israel | |
Ziv Medical Center | |
Safed, Israel |
Study Director: | Mark L Levitt, MD, PhD | RedHill Biopharma Limited |
Documents provided by RedHill Biopharma Limited:
Responsible Party: | RedHill Biopharma Limited |
ClinicalTrials.gov Identifier: | NCT04414618 |
Other Study ID Numbers: |
ABC-110 |
First Posted: | June 4, 2020 Key Record Dates |
Results First Posted: | March 21, 2022 |
Last Update Posted: | March 21, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Coronavirus Infections Respiratory Tract Infections Infections Lung Diseases |
Respiratory Tract Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases |