A Study of Opaganib in Coronavirus Disease 2019 Pneumonia

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronavirus Infections

In brief

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.

Key facts

Study ID

NCT04414618

Run by

RedHill Biopharma Limited

People needed

42

Starts

2020-07-02

Expected to finish

2020-12-23

Last updated by the study team

2022-03-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 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.

Where it is running

• HonorHealth Research Institute — Scottsdale, Arizona, United States
• Miami Cancer Institute — Miami, Florida, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Ascension St. John Hospital — Detroit, Michigan, United States
• Albany Medical Center — Albany, New York, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Memorial Herman Southeast Hospital — Houston, Texas, United States
• Memorial Hermann, Memorial City Medical Center — Houston, Texas, United States
• Ziv Medical Center — Safed, Israel

Full record on ClinicalTrials.gov

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