A Study of Opaganib in Coronavirus Disease 2019 Pneumonia

NCT04414618 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ABC-110
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 9

Brief 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. 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.

Conditions

Coronavirus Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (8)

• Measurement of Time to the Reduction in Oxygen Requirement.

  14 days

• The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14

  14 days

• Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment

  6 weeks

• The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14

  14 days

• Intubation and Mechanical Ventilation Requirements

  From screening phase and every day from day 1 to day 14 of treatment

Other Outcomes (2)

• Safety TEAEs

  6 weeks

• Safety SAEs

  6 weeks

Study Arms (2)

opaganib

ACTIVE COMPARATOR

Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours

Drug: Opaganib

placebo

PLACEBO COMPARATOR

Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours

Drug: Placebo

Interventions

Opaganib DRUG

Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).

Also known as: Yeliva, ABC294640

opaganib

Placebo DRUG

Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).

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
• The patient requires supplemental oxygen at baseline
• The patient, guardian or legal representative has signed a written IRB-approved informed consent.
• \) 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• RedHill Biopharma Limited: lead

Study Sites (9)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Memorial Herman Southeast Hospital

Houston, Texas, 77089, United States

Location

Memorial Hermann, Memorial City Medical Center

Houston, Texas, 77204, United States

Location

Ziv Medical Center

Safed, Israel

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

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

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Vered Katz Ben-Yair
• Organization: RedHill Biopharma Ltd.

vered@redhillbio.com

+13474144462

Study Officials

• Mark L Levitt, MD, PhD

  RedHill Biopharma Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: May 26, 2020
• First Posted: June 4, 2020
• Study Start: July 2, 2020
• Primary Completion: November 26, 2020
• Study Completion: December 23, 2020
• Last Updated: March 21, 2022
• Results First Posted: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); IL (1)