This study is a multicenter, randomized, placebo-control, efficacy and safety study of VERU-111 for the treatment of COVID-19. Subjects will receive either 18 mg of VERU-111 or matching placebo orally or through nasogastric tube daily for up to 21 days or until the subject is discharged from the hospital, whichever comes first.
The primary efficacy endpoint of the study will be the proportion of subjects that are alive without respiratory failure at Day 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO). The total study duration for a subject from screening to follow up visit is planned to be 62 days.
An evaluation of the effect of VERU-111 on SARS-CoV-2 (COVID-19) compared to the placebo control will be evaluated after the last subject has completed Day 22. This will allow for the decision to move to Phase 3 more quickly if the Phase 2 portion of the study shows a clinically relevant difference in the proportion of subjects that are alive without respiratory failure at Day 22 in the VERU-111 treated groups compared to the Placebo treatment group, and VERU-111 is well tolerated in the study.
You may be eligible to participate in this study if you meet the following criteria:
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test
- Patients hospitalized with oxygen supplementation (oxygen by mask or nasal prongs) at high risk for ARDS, must have at least one of the known comorbidities for being at high risk, such as:
- Asthma (moderate to severe)
- Chronic lung disease
- Severe obesity (BMI ≥ 40)
- 65 years of age or older
- primarily reside in a nursing home or long-term care facility,
- or immunocompromised
- Patients hospitalized with oxygen supplementation (non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation),
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening (could be an ER value during admission)
Clinical Trial Investigator
Dr. Jose David Suarez, Principal Investigator