Phase 2 Trial to Evaluate Safety and Efficacy of CYTO-205 in Mild COVID-19
Status:
Not yet recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, placebo-controlled study. The aim of the study is to
assess the safety and clinical efficacy of low-dose naltrexone in reducing the proportion of
higher risk patients who progress from mild COVID-19 to a more severe disease category.
Male and female participants with a confirmed positive SARS-CoV-2 diagnostic test at
screening, who are symptomatic with mild COVID-19 (as measured by WHO clinical progression
scale, WHOb 2020) and are at high risk for COVID-19 progression will be enrolled. High risk
is based on presence of one or more criteria which could include age ≥65 years, increased BMI
≥33 kg/m2, or the presence of certain comorbidities (refer to Section 4 for complete
eligibility criteria).