Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia

NCT04467840 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ABC-201
• Study Type: interventional
• Target: 475
• Locations: 10 countries
• Sites: 57

Brief Summary

A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the potential of opaganib to improve and/or stabilize the clinical status of the patient.

Conditions

COVID-19; Lung Infection

Keywords

Therapeutic Use

Outcome Measures

Primary Outcomes (1)

• Supplemental Oxygen Requirement

  To compare the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14 between subjects taking opaganib and those on placebo.

  14 days maintained up to 42 days

Secondary Outcomes (9)

• Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42

  14 days maintained up to 42 days

• Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement With a Scale Ranging From 8 Down to 0

  14 days maintained up to 42 days

• Number of Participants With Low Oxygen Flow Via Nasal Cannula

  14 days maintained up to 42 days

• Time to Discharge From Hospital Measured at 14 Days

  14 days

• Patients Requiring Intubation and Mechanical Ventilation by Day 42

  42 days

Other Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  From first dose until 4 weeks follow-up after the end of treatment

Study Arms (2)

Opaganib

EXPERIMENTAL

In addition to standard of care, opaganib will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. When required this may be made into a suspension form and may be administered by nasogastric tube.

Drug: Opaganib

Placebo

PLACEBO COMPARATOR

In addition to standard of care, a matching placebo will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Drug: Placebo

Interventions

Opaganib DRUG

Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).

Also known as: Yeliva, ABC294640

Opaganib

Placebo DRUG

Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or CT scan. that diagnosed COVID-19 pneumonia. Pharyngeal samples collected either at screening or within 7-days prior to screening for the same ongoing COVID-19 pneumonia illness are acceptable
• The patient requires, at baseline, high flow supplemental oxygen or positive pressure ventilation or is receiving oxygen via face mask, such as a non-rebreather or reservoir mask, capable of delivering high concentrations of oxygen
• Patient agrees to use appropriate methods of contraception during the study and 3 months after the last dose of study drug
• The patient or legal representative has signed a written informed consent approved by the IRB/Ethics Committee

You may not qualify if:

• Any co-morbidity that may add risk to the treatment in the judgment of the investigator, particularly patients with known cardiac conditions, and serious neuropsychiatric conditions such as psychosis or major depression
• Requiring intubation and mechanical ventilation at baseline
• Patient has a 'Do Not Intubate' and/or 'Do Not Resuscitate' order in place
• 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 judgement, unlikely to survive \>72 hours
• Pregnant (positive serum or urine test within 3 days prior to randomization) 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) \> 2.0 x upper limit of normal (ULN)
• Total bilirubin \>1.5x 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

Sponsors & Collaborators

• RedHill Biopharma Limited: lead

Study Sites (57)

ABC-201 Site 901

Detroit, Michigan, 00000, United States

Location

ABC-201 Site 408

Belo Horizonte, Brazil

Location

ABC-201 Site 411

Belo Horizonte, Brazil

Location

ABC-201 Site 405

Joinville, Brazil

Location

ABC-201 Site 404

Paraná, Brazil

Location

ABC-201 Site 410

Passo Fundo, Brazil

Location

ABC-201 Site 409

Porto Alegre, Brazil

Location

ABC-201 Site 402

São Bernardo do Campo, Brazil

Location

ABC-201 Site 401

São Paulo, Brazil

Location

ABC-201 Site 403

São Paulo, Brazil

Location

ABC-201 Site 407

Tubarão, Brazil

Location

ABC-201 Site 604

Medellín, Antioquia, Colombia

Location

ABC-201 Site 603

Bogotá, Colombia

Location

ABC-201 Site 605

Cundinamarca, Colombia

Location

ABC-201 Site 602

Medellín, Colombia

Location

ABC-201 Site 601

Santiago de Cali, Colombia

Location

ABC-201 Site 708

Ashkelon, Ashketon, Israel

Location

ABC-201 Site 702

Ashdod, Israel

Location

ABC-201 Site 704

Holon, Israel

Location

ABC-201 Site 701

Jerusalem, Israel

Location

ABC-201,Site 709

Kfar Saba, Israel

Location

ABC-201 Site 705

Nahariya, Israel

Location

ABC-201 Site 706

Nazareth, Israel

Location

ABC-201 Site 703

Safed, Israel

Location

ABC-201 Site 203

Alessandria, Italy

Location

ABC-201 Site 201

Lecco, Italy

Location

ABC-201 Site 202

Milan, Italy

Location

ABC-201 Site 204

Torino, Italy

Location

ABC-201 Site 501

Mexico City, Mexico

Location

ABC-201 Site 503

Sinaloa, Mexico

Location

ABC-201 Site 655

Lima, Peru

Location

ABC-201 Site 303

Bolesławiec, Poland

Location

ABC-201 Site 306

Katowice, Poland

Location

ABC-201 Site 304

Koszalin, Poland

Location

ABC-201 Site 308

Lodz, Poland

Location

ABC-201 Site 307

Lublin, Poland

Location

ABC-201 Site 302

Ostróda, Poland

Location

ABC-201 Site 301

Racibórz, Poland

Location

ABC-201 Site 305

Wroclaw, Poland

Location

ABC-201 Site 110

Barnaul, Russia

Location

ABC-201 Site 122

Kirovsk, Russia

Location

ABC-201 Site 101

Moscow, Russia

Location

ABC-201 Site 132

Moscow, Russia

Location

ABC-201 Site 120

Murmansk, Russia

Location

ABC-201 Site 103

Ryazan, Russia

Location

ABC-201 Site 114

Ryazan, Russia

Location

ABC-201 Site 109

Saint Petersburg, Russia

Location

ABC-201 Site 111

Saint Petersburg, Russia

Location

ABC-201 Site 129

Saint Petersburg, Russia

Location

ABC-201 Site 108

Saratov, Russia

Location

ABC-201 Site 102

Smolensk, Russia

Location

ABC-201 Site 104

Tver', Russia

Location

ABC-201 Site 118

Volgograd, Russia

Location

ABC-201 Site 112

Yaroslavl, Russia

Location

ABC-201 Site 253

Antrim, United Kingdom

Location

ABC-201 Site 251

Gillingham, United Kingdom

Location

ABC-201 Site 252

Taunton, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

3-(4-chlorophenyl)-adamantane-1-carboxylic acid (pyridin-4-ylmethyl)amide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gilead Raday, COO
• Organization: RedHill Biopharma Ltd.

info@redhillbio.com

+972-(0)3-541-3131

Study Officials

• Mark L Levitt, MD

  RedHill Biopharma Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 13, 2020
• Study Start: August 21, 2020
• Primary Completion: July 18, 2021
• Study Completion: July 18, 2021
• Last Updated: July 31, 2025
• Results First Posted: October 19, 2023

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BR (10); IL (8); CO (5); IT (4); PL (8); GB (3); RU (15); ME (2); PE (1)