Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05365321
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2022-04-26
Brief Title:
Clinical Trial of Efficacy and Safety of Oral Drug in Adult Patients With COVID-19
Sponsor:
Andrei Carvalho Sposito
Organization:
University of Campinas Brazil
Study Overview
Official Title:
A Phase 12 Dose Escalation and Randomized Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Oral WP1122 in Adult Patients With Advanced Coronavirus Disease 2019 COVID-19
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WP1122
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None