Ridgeback Biotherapeutics announces the launch of two phase II clinical trials to test the efficacy of EIDD 2801 as an anti-viral treatment for COVID-19.Merck Inc.

Ridgeback Biotherapeutics announces the launch of two Phase II clinical trials to test the efficacy of EIDD 2801 as an anti-viral treatment for COVID-19. Phase I trials recently determined that EIDD 2801 is safe in human doses that provide blood levels well above levels that animal models suggest should be effective against SARS-CoV-2, the virus which causes COVID-19.

EIDD 2801 will be administered to patients 18 years old and over in two studies: Study 2003 will enroll recently symptomatic, newly diagnosed patients in a home, or out of hospital, setting; Study 2004 will enroll hospitalized patients with COVID-19. To ensure that EIDD 2801 is rapidly available for patients if the medicine proves to be an effective treatment for COVID-19, Ridgeback has been manufacturing hundreds of thousands of doses at its own risk and expense — with plans for the company to produce as many as a million treatment courses by the fall even in advance of definitive clinical data. Ridgeback plans to initiate large multi thousand patient confirmatory studies for EIDD 2801 in COVID-19 patients beginning in July.

About Study 2004 :Newly hospitalized COVID-19 patients who are 18 years and older with a positive PCR by nasopharyngeal swab will be randomized to one of 2 doses of EIDD 2801 or placebo. Patients will receive 2 daily oral doses for 5 days. Multiple oral and upper airway samples will be followed for reduction in viral load and viral status and patients will be followed for clinical endpoints. The primary objectives of the study are improvement in time to negativity on PCR as well as safety. Secondary endpoints include time to discharge, improvement in symptoms, use of mechanical ventilation and survival. Patients will also be followed for time to viral negativity by viral culture.

About Study 2003: Newly diagnosed non hospitalized COVID-19 patients who are 18 years and older with a positive PCR by nasopharyngeal swab will be randomized to EIDD 2801 or placebo. Patients will receive 2 daily oral doses for 5 days. Multiple oral and upper airway samples will be followed for reduction in viral load and viral status and patients will be followed for clinical endpoints. The primary objectives of the study are improvement in time to negativity on PCR and safety. Secondary endpoints include time to discharge, improvement in symptoms, use of mechanical ventilation and survival. Patients will also be followed for time to viral negativity by viral culture.