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VERU-111 · 2 trials · 2 indications
Efficacy of VERU-111 in the treatment of SARS-Cov- 2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 29. Respiratory failure is defined as endotracheal intubation and mechanical ventilation, extracorporeal membrane oxygenation, high-flow nasal cannula oxygen delivery, noninvasive positive pressure ventilation, clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision making is driven solely by resource limitation
| Arm | Type | Description |
|---|---|---|
| 9mg of VERU-111 Oral daily | EXPERIMENTAL | 9mg of VERU-111 |
| Placebo Capsule once daily | NO_INTERVENTION | Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital. |
| Veru-111 18 mg | EXPERIMENTAL | Veru-111 18mg capsules |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules |
| Name | Type | Description |
|---|---|---|
| VERU-111 | DRUG | Subjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital. |
Inclusion Criteria: * Provide informed consent from the subject or the subject's Legally Authorized Representative (LAR) * Aged ≥18 years * Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test * Patients with a WHO Ordinal Scale for ...
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VERU-111 is an investigational small molecule being studied for the treatment of SARS-CoV-2 infection and adult respiratory distress syndrome. It is being developed by Veru Inc. and has been evaluated in clinical trials for these conditions.
VERU-111 is a small molecule that targets tubulin, disrupting microtubule dynamics. This mechanism is being investigated for its potential to treat SARS-CoV-2 infection and respiratory distress syndrome by affecting viral replication and inflammatory responses.
VERU-111 is being developed by Veru Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating SARS-CoV-2 infection and respiratory distress syndrome.
VERU-111 is in Phase 3 clinical development. It has completed a Phase 2 trial and a Phase 3 trial, both of which have been completed. The drug is still investigational and has not been approved by regulatory authorities.
VERU-111 has been studied in two completed clinical trials. NCT04388826 was a Phase 2 trial in patients with adult respiratory distress syndrome, and NCT04842747 was a Phase 3 trial in patients with SARS-CoV-2 infection. Both trials were randomized and double-blind.
VERU-111 is also known as sabizabulin. The drug is being developed by Veru Inc. and has been evaluated in clinical trials for the treatment of SARS-CoV-2 infection and respiratory distress syndrome.