Therapy Areas: AIDS & HIV
Enterin intends to launch randomized Phase 1/2a study in hospitalized COVID-19 patients
20 April 2020 -

Neurodegenerative treatment company Enterin Inc said on Friday that it plans to conduct Phase 1/2a study of COV-ENT-1 via by inhalation via standard nebulizer in 80 hospitalized patients with COVID-19 infection in ten US sites following US FDA approval.

Under the company's trial, patients diagnosed with SARS-CoV-2, have an SpO2 ≤94% or evidence of pneumonia by chest XR or CT scan. The first stage will involve 24 patients randomized in groups of four to escalating doses of COV-ENT-1 or placebo. The second stage will involve another 56 patients randomized to COV-ENT-1 or placebo at the highest tolerable doses. Patients will be followed for 28 days.

Following establishment of the dosing regimen, the company will develop a powdered, metered-dose, hand-held inhaler to treat patients with acute respiratory conditions including COVID-19. COV-ENT-1 has been shown to have broad-spectrum antiviral activity against both RNA and DNA viruses, both in vitro and in vivo, in studies supported by the National Institutes of Allergy and Infectious Diseases (NIAID).

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