The company Pardes Biosciences, Inc is commencing recruitment for the clinical trial of the PBI-0451 Phase 2 Study in Nonhospitalized Symptomatic Adults With COVID-19. The study will take place at several investigational sites in Florida, the USA.
PBI-0451 is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. This study is designed to evaluate the antiviral activity, safety, and efficacy of orally administered PBI-0451 compared with placebo.
Among the primary inclusion criteria are:
- Can understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of any study procedures.
- Onset of COVID-19 symptoms ≤ 5 days prior to randomization with a positive SARS-CoV-2 test ≤ 24 hours prior to randomization. Authorized NAAT or antigen tests that detect viral RNA or protein, respectively, are allowed.
- Received primary vaccination series as defined by Centers for Disease Control and Prevention (CDC). Subjects should be advised during informed consent that alternate therapies may be available outside of study participation.
The link to the complete list of the inclusion/excluison criteria, and the sites contact details: https://ichgcp.net/clinical-trials-registry/NCT05543707.