Trials / Unknown
UnknownNCT05365321
Clinical Trial of Efficacy and Safety of Oral Drug in Adult Patients With COVID-19
A Phase 1/2, 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
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Andrei Carvalho Sposito · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WP1122 | Doses from 8 mg/kg will be increased in doubling increments up to 64 mg/kg in the dose escalation Phase 1 portion of the study, administered orally (PO) for 10 days q12h ±1h. The dose in Phase 2 will utilize the Maximum Tolerated Dose (MTD) established in Phase 1 and also administered PO q12h ± 1h for 10 days. |
Timeline
- Start date
- 2022-12-01
- Primary completion
- 2023-02-01
- Completion
- 2023-10-01
- First posted
- 2022-05-09
- Last updated
- 2022-05-09
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05365321. Inclusion in this directory is not an endorsement.