drugset / Trial / NCT05365321

Clinical Trial of Efficacy and Safety of Oral Drug in Adult Patients With COVID-19

NCT05365321 ↗

Phase 1/2 Unknown 75 enrolled Andrei Carvalho Sposito
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase 1, multi-center, dose escalation study that is followed by a Phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of WP1122 administered q12h ±1 hr PO in adult patients with COVID-19 who require hospitalization with respiratory support. The Phase 1 component will enroll COVID-19 positive patients who are symptomatic and the Phase 2 component will enroll adults with COVID-19 who require hospitalization for respiratory support and those patients requiring intubation with mechanical ventilation.

Timeline

Start
2022-12
Primary completion
2023-02
Completion
2023-10

Drugs

EvaluationDrugModalityDoseRoute
Subject WP1122 Small molecule 8 mg/kg Oral
Subject WP1122 Small molecule 16 mg/kg Oral
Subject WP1122 Small molecule 32 mg/kg Oral
Subject WP1122 Small molecule 64 mg/kg Oral