Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients
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|ClinicalTrials.gov Identifier: NCT04523181|
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid-19||Drug: Antroquinonol Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||174 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A Phase 2 Randomized, Double blind, Placebo Controlled, Proof of Concept Study to Evaluate the Safety and Efficacy of Antroquinonol in Hospitalized Patients with Mild to Moderate Pneumonia due to COVID 19|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind, Placebo Controlled|
|Official Title:||A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Safety and Efficacy of Antroquinonol in Hospitalized Patients With Mild to Moderate Pneumonia Due to COVID-19|
|Actual Study Start Date :||October 8, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
Active Comparator: Antroquinonol with SOC
Antroquinonol in a dose of 100 mg (1 capsule) administered twice daily (BID) orally, for 14 days.
double-blind for antroquinonol and Placebo with same out-look and same frequency.
Other Name: Hocena
Placebo Comparator: Placebo with SOC
placebo (1 capsule) administered twice daily (BID) orally, for 14 days.
Capsule without active compound
- recover ratio [ Time Frame: 14 day ]The proportion of patients who are alive and free of respiratory failure (e.g., no need for invasive mechanical ventilation, non invasive ventilation, high flow oxygen, or ECMO) on Day 14
- Time to 2-point improvement [ Time Frame: 28 day ]Clinical change score as measured by the WHO COVID-19 Clinical Improvement Ordinal Scale
- Duration of hospitalization [ Time Frame: 28 day ]time for patient discharge
- Time to virological clearance [ Time Frame: 28 day ]measured as study days from start of treatment to first negative SARS CoV 2 PCR test
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): NCT04523181