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A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19

NCT04750278 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-01-05

Study results available
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Summary

This is a Phase 2/3, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy and safety of FP-025 in adult patients with severe to critical COVID 19 with associated ARDS.

Conditions

  • Severe to Critical COVID 19 With Associated ARDS

Interventions

DRUG

FP-025 100 mg

FP-025 100 mg BID

DRUG

FP-025 300 mg

FP-025 300 mg BID

DRUG

Placebo

Placebo BID

Sponsors & Collaborators

  • Foresee Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Susan Shelby, Ph.D. · Sr. Vice President Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2022-04-18
Completion
2022-04-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04750278 on ClinicalTrials.gov