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Study of Varespladib in Patients Hospitalized With Severe COVID-19

NCT04969991 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-15

Study results available
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Summary

This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability, and efficacy of oral varespladib, in addition to standard of care, in patients hospitalized with severe COVID-19 caused by SARS-CoV-2.

Conditions

  • Coronavirus Disease 2019
  • Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

DRUG

Varespladib

250 mg immediate-release oblong, white, film-coated tablet for oral administration

DRUG

Placebo

Oral formulation matched to the oral varespladib tablet

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Ophirex, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2022-02-11
Completion
2022-11-22
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 NCT04969991 on ClinicalTrials.gov