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

NCT05365321 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-05-09

No results posted yet for this study

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

  • COVID-19
  • Mechanical Ventilation Complication
  • COVID-19 Acute Respiratory Distress Syndrome

Interventions

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.

Sponsors & Collaborators

  • Andrei Carvalho Sposito

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-02-28
Completion
2023-10-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05365321 on ClinicalTrials.gov