Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen (Opaganib-RHB)
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|ClinicalTrials.gov Identifier: NCT04502069|
Recruitment Status : Withdrawn (To be replaced with a randomized placebo-controlled study.)
First Posted : August 6, 2020
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Lung Infection||Drug: Opaganib||Phase 1 Phase 2|
Patients diagnosed with COVID-19 infection by nasopharyngeal viral swab, classified as severe disease, category 5, by the WHO Ordinal Scale For Clinical Improvement (who require oxygen support by high flow nasal cannula but do not require mechanical ventilation) at the time of initiation of therapy will be offered treatment with Opaganib, 500 mg Q12 hours.
Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks), upon voluntary withdrawal is initiated by the patient or when the physician decides that it is not in the patient's best interest to continue.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Open label opaganib
opaganib dosed at 500 mg Q12 hours
500 mg Q12 hours orally
- Time to breathing room air [ Time Frame: Up to 2 weeks ]To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.
- Adverse Event Grading and Coding [ Time Frame: Up to 2 weeks ]All adverse events will be graded according to the revised NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0). If an AE is not listed in the NCI-CTCAE v.5.0, then the Investigator will use the terms: mild, moderate, severe, life-threatening, or death to describe the maximum intensity of the AE.
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): NCT04502069
|Shaare Zedek Medical Center|
|Study Director:||Mark L Levitt, MD||RedHill Biopharma Limited|