A Study of Opaganib in Coronavirus Disease 2019 Pneumonia (COVID-19)
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|ClinicalTrials.gov Identifier: NCT04414618|
Recruitment Status : Completed
First Posted : June 4, 2020
Results First Posted : March 21, 2022
Last Update Posted : March 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infections||Drug: Opaganib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||November 26, 2020|
|Actual Study Completion Date :||December 23, 2020|
Active Comparator: opaganib
Study participants will receive opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours
Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
Placebo Comparator: placebo
Study participants will receive placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours
Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
- Measurement of the Change in Oxygen Requirement From Baseline [ Time Frame: 14 days ]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.
- Measurement of Time to the Reduction in Oxygen Requirement. [ Time Frame: 14 days ]The time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min.
- The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14 [ Time Frame: 14 days ]The percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14.
- Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment [ Time Frame: 6 weeks ]The time in each arm to two consecutive negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab, at least 24 hrs. apart.
- The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14 [ Time Frame: 14 days ]The percentage of subjects in each arm to achieve two consecutive negative PCR nasopharyngeal or oropharyngeal swabs for SARS-CoV-2 at Day 14, at least 24 hrs. apart.
- Intubation and Mechanical Ventilation Requirements [ Time Frame: From screening phase and every day from day 1 to day 14 of treatment ]The percentage of patients in each arm who require intubation and mechanical ventilation by Day 14
- Evaluation of the Time to Intubation and Mechanical Ventilation [ Time Frame: From screening phase and every day from day 1 to day 14 of treatment ]The time in each arm for the patient to require mechanical ventilation.
- 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 ]The proportion of patients in each arm, 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
- Evaluation of Mortality 30 Days Post-baseline [ Time Frame: 30 days after day 1 of treatment ]The mortality in each arm 30 days post-baseline.
- Safety TEAEs [ Time Frame: 6 weeks ]The number of subjects with treatment-emergent adverse events in each arm of all treatment-emergent adverse events (TEAEs).
- Safety SAEs [ Time Frame: 6 weeks ]The number of subjects with serious adverse events (SAEs) in each arm.
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
|United States, Arizona|
|HonorHealth Research Institute|
|Scottsdale, Arizona, United States, 85258|
|United States, Florida|
|Miami Cancer Institute|
|Miami, Florida, United States, 33176|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Ascension St. John Hospital|
|Detroit, Michigan, United States, 48236|
|United States, New York|
|Albany Medical Center|
|Albany, New York, United States, 12208|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|Memorial Herman Southeast Hospital|
|Houston, Texas, United States, 77089|
|Memorial Hermann, Memorial City Medical Center|
|Houston, Texas, United States, 77204|
|Ziv Medical Center|
|Study Director:||Mark L Levitt, MD, PhD||RedHill Biopharma Limited|