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Trial record 4 of 4 for:    redhill biopharma | Covid19

A Study of Opaganib in Coronavirus Disease 2019 Pneumonia (COVID-19)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04414618
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited

Brief Summary:
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 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.

Condition or disease Intervention/treatment Phase
Coronavirus Infections Drug: Opaganib Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: opaganib
Study participants will receive opaganib 2 x 250 mg capsules (500 mg) every 12 hours
Drug: Opaganib
Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive).
Other Names:
  • Yeliva
  • ABC294640

Placebo Comparator: placebo
Study participants will receive placebo 2 x 250 mg capsules (500 mg) every 12 hours
Drug: Placebo
Study participants will receive placebo 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive).




Primary Outcome Measures :
  1. Evaluation of the total oxygen requirement (area under the curve) using daily supplemental oxygen flow (L/min) over 14 days [ Time Frame: Every day from day 1 to day 14 of treatment ]
    Measurement of the oxygen requirement


Secondary Outcome Measures :
  1. Evaluation of the time to 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min [ Time Frame: Every day from day 1 to day 14 of treatment ]
    Measurement of the oxygen requirement

  2. Evaluation of the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14 [ Time Frame: From screening phase and every day from day 1 to day 14 of treatment ]
  3. Evaluation of the proportion of afebrile patients at Day 14 [ Time Frame: From screening phase and every day from day 1 to day 14 of treatment ]
    Measurement of temperature

  4. Evaluation of the time to negative swabs for SARS-CoV-2 by PCR [ Time Frame: From screening phase and every day from day 1 to day 14 of treatment and at the end of the 4 weeks follow-up after the end of treatment ]
    Nasopharyngeal or oropharyngeal swab for SARS-CoV-2

  5. Evaluation of the proportion of patients with negative swabs for SARS-CoV-2 by PCR at Day 14 [ Time Frame: From screening phase and every day from day 1 to day 14 of treatment and at the end of the 4 weeks follow-up after the end of treatment ]
    Nasopharyngeal or oropharyngeal swab for SARS-CoV-2

  6. The percentage of patients who require intubation and mechanical ventilation by Day 14 [ Time Frame: From screening phase and every day from day 1 to day 14 of treatment ]
  7. Evaluation of the time to mechanical ventilation [ Time Frame: From screening phase and every day from day 1 to day 14 of treatment ]
  8. 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 the proportion of patients, 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

  9. Evaluation of mortality 30 days post-baseline [ Time Frame: 30 days after day 1 of treatment ]

Other Outcome Measures:
  1. To determine the incidence rate of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Every day from day 1 to day 14 of treatment and at end of the 4 weeks follow-up after the end of treatment ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult male or female ≥18 to ≤80 years of age
  2. 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
  3. The patient requires supplemental oxygen at baseline
  4. The patient, guardian or legal representative has signed a written IRB-approved informed consent

Exclusion Criteria:

  1. Any co-morbidity that may add risk to the treatment in the judgement of the investigator.
  2. Requiring intubation and mechanical ventilation
  3. Oxygen saturation >95% on room air
  4. Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
  5. Patient is, in the investigator's clinical judgment, unlikely to survive >72 hours
  6. Pregnant or nursing women
  7. Unwillingness or inability to comply with procedures required in this protocol.
  8. Corrected QT (QTc) interval on electrocardiogram (ECG) >470 ms for females or >450 ms for males, calculated using Friedericia's formula (QTcF)
  9. AST (SGOT) or ALT (SGPT) > 2.5 x upper limit of normal (ULN)
  10. Bilirubin >1.5x ULN (except where bilirubin increase is due to Gilbert's Syndrome)
  11. Serum creatinine >2.0 X ULN
  12. Absolute neutrophil count <1000 cells/mm3
  13. Platelet count <75,000/mm3
  14. Hemoglobin <8.0 g/dL
  15. Currently taking medications that are sensitive CYP3A4, CYP2C9 or CYP2C19 substrates and have a narrow therapeutic index
  16. Currently taking medications that are strong inducers or inhibitors of CYP2D6 and CYP3A4
  17. Currently taking warfarin, apixaban, argatroban or rivaroxaban
  18. Current drug or alcohol abuse
  19. Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies

Information from the National Library of Medicine

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


Contacts
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Contact: Mark L Levitt, MD, PhD +972-3-541-3131 mark@redhillbio.com
Contact: Vered Katz Ben-Yair, MSc +972-3-541-3131 vered@redhillbio.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Michael Gordon, MD         
United States, Florida
Miami Cancer Institute Recruiting
Miami, Florida, United States, 33176
Contact: Guenther Koehne, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Julian Suszanski, MD         
Ascension St. John Hospital Recruiting
Detroit, Michigan, United States, 48236
Contact: Daniel Lebovic, MD         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Scott Beegle, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kevin Winthrop, MD, MPH    503-494-4971    winthrop@ohsu.edu   
United States, Texas
Memorial Herman Southeast Hospital Recruiting
Houston, Texas, United States, 77089
Contact: Adnan Rapiq, MD         
Memorial Hermann, Memorial City Medical Center Recruiting
Houston, Texas, United States, 77204
Contact: Alan Skolnick, MD         
Sponsors and Collaborators
RedHill Biopharma Limited
Investigators
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Study Director: Mark L Levitt, MD, PhD RedHill Biopharma Limited
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Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT04414618    
Other Study ID Numbers: ABC-110
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases