Study of Varespladib in Patients Hospitalized With Severe COVID-19

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Coronavirus Disease 2019, Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2

In brief

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.

Key facts

Study ID

NCT04969991

Run by

Ophirex, Inc.

People needed

18

Starts

2021-06-30

Expected to finish

2022-11-22

Last updated by the study team

2025-05-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is hospitalized with severe COVID-19 illness, defined in accordance with the Food and Drug Administration (FDA) Guidance for Industry - COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (May 2020):
• a. Severe illness:
• i. Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress
• ii. Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, SpO₂ ≤93% on room air at sea level or partial pressure of oxygen PaO₂/fraction of inspired oxygen FiO₂ <300.
• Participant has a positive virologic nucleic acid amplification test (NAAT) indicating SARS-CoV-2 infection in a sample collected <72 hours prior to randomization.
• Participant is between the ages of 18 and 80 years at the time of enrollment.
• Participant provides informed consent prior to initiation of any study procedures.
• Participant agrees to not participate in another clinical trial for the treatment of COVID 19 or SARS-CoV-2 through Day 28.
• Participant has adequate hematologic status (in the absence of transfusion and growth factor support for at least 28 days), defined as follows:
• Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
• Platelet count ≥75 × 10⁹/L
• Hemoglobin ≥9 g/dL.
• Participant has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.

You may not qualify if…

• Participant has mild, moderate, or critical COVID-19 defined in accordance with the FDA Guidance for Industry:
• a. Mild COVID-19:
• i. Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea
• ii. No clinical signs indicative of moderate, severe, or critical severity
• b. Moderate COVID-19:
• i. Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness (fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms) or shortness of breath with exertion
• ii. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥20 breaths per minute, peripheral oxygen saturation (SpO₂) >93% on room air at sea level, heart rate ≥90 beats per minute
• iii. No clinical signs indicative of severe or critical illness
• c. Critical COVID-19:
• i. Respiratory failure defined based on resource utilization requiring at least one of the following:
• Endotracheal intubation and mechanical ventilation
• Oxygen delivered by high-flow nasal cannula ([HFNC] heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5)
• Noninvasive positive pressure ventilation
• ECMO, or
• Clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
• ii. Shock (defined by systolic blood pressure <90 mmHg, or diastolic blood pressure <60 mmHg or requiring vasopressors)
• iii. Multi-organ dysfunction/failure.
• Participant has taken investigational medications within 7 days or 5 half-lives prior to enrollment, whichever is shorter.
• Participant has required any new form of sedation, anxiolysis or central nervous system (CNS) depressant within the 48 hours prior to enrollment that would interfere with neurologic assessments at enrollment.
• Has history of cerebrovascular accident or intracranial bleeding of any kind, acute coronary syndrome, myocardial infarction, or severe pulmonary hypertension.
• Participant has chronic respiratory failure not associated with COVID-19, defined as prior need for home oxygen, need for home noninvasive positive-pressure ventilation (NIPPV) for reasons other than isolated sleep apnea, or other signs of chronic respiratory failure, in the investigator's judgment.
• Upper gastrointestinal (GI) bleed evidenced by hematemesis, "coffee-ground" emesis or nasogastric aspirate, or hematochezia thought to originate from upper GI tract.
• Participant has abnormal liver function defined as any 2 of the following at screening:
• Total bilirubin ≥2 × ULN
• Alanine aminotransferase (ALT) ≥3 × ULN

Where it is running

• Ventura Clinical Trials — Ventura, California, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Westchester Research Center at Westchester General Hospital — Miami, Florida, United States
• Franciscan Alliance — Munster, Indiana, United States
• The Brigham and Women's Hospital Emergency Medicine — Boston, Massachusetts, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Ascension St. John Clinical Research Institute — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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