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Study of Varespladib in Patients Hospitalized With Severe COVID-19 (STAIRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04969991
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : August 23, 2021
Sponsor:
Collaborator:
Premier Research International LLC
Information provided by (Responsible Party):
Ophirex, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 Drug: Varespladib Drug: Placebo Phase 2

Detailed Description:

The goals of this 2-part, multi-center, randomized, double-blind, placebo-controlled, phase 2 study are to define a safe dose for the population and to assess the safety, tolerability, and efficacy of orally dosed varespladib to improve survival without respiratory failure in patients hospitalized with severe coronavirus disease 2019 (COVID-19), when given in addition to the institutional standard of care therapy.

Mortality rates of COVID-19 are strongly linked to acute respiratory distress syndrome (ARDS) which may be, additionally, correlated with elevations of secretory phospholipase 2 (sPLA2) and widespread loss of functioning lung tissue. Upregulation of sPLA2 is thought to be involved in the dysregulated inflammatory cascade pathways (increased markers of immune activation, also known as cytokine release syndrome) and enzymatic degradation of lung surfactant linked to the development of ARDS. It is believed that treatment with varespladib, a potent inhibitor of sPLA2, might prevent or mitigate progression of pulmonary dysfunction in COVID-19 patients by two mechanisms: suppression of sPLA2-induced inflammation and, uniquely, preservation of pulmonary surfactant by direct inhibition of the enzyme responsible for surfactant phospholipid degradation: sPLA2.

Data from previous phase 2 clinical trials of varespladib suggested it had potential to reduce mortality in severely septic patients with ARDS, particularly when treatment was initiated within 18 hours of identification of organ failure.

The study will be conducted in two parts. Both parts will be randomized and double-blind. Part 1 will be dose-finding in four parallel treatment groups randomized to treatment with varespladib (at 250 mg once daily [QD], twice daily [BID], or three times daily [TID] [250, 500, or 750 mg/day]) or placebo in a 5:5:5:3 ratio. After all participants in Part 1 have completed Day 28, a data safety monitoring board (DSMB) will review the safety results from Part 1, including all available safety data through Day 60, and will recommend the dose regimen to be used in Part 2. Part 2 will randomize an additional 72 participants to the dose regimen selected from Part 1 or placebo in a 1:1 ratio.

In both parts of the study, eligible participants will be enrolled and randomized to receive active varespladib or placebo in addition to institutional standard of care for 7 days.

Participants will be assessed daily per standard of care while hospitalized and on a regular basis after discharge. The Day 1, 4, 7, 14, and 28 visits will be performed in person (either at the hospital/site or via a home health provider) to assess safety, obtain blood and urine samples for laboratory tests, and obtain clinical outcome data. The Day 2, 3, 5, 6, 8, 9, 10, 11, 12, 13, 15, 16, 17, 18, 19, 20, 21, 45, and 60 visits for discharged participants may be conducted by phone or via electronic patient-reported outcome (ePRO) devices.

Efficacy will be assessed by respiratory failure-free survival at Day 28. Safety will be assessed by evaluating adverse events (AEs), vital sign measurements, use of oxygen therapies, changes in levels of biomarkers, clinical laboratory test results, electrocardiograms (ECGs), physical examination findings, and concomitant medications and therapies. A DSMB will evaluate safety data at specified intervals during both parts of the trial.

Pharmacokinetic (PK) samples will be drawn from all participants in Part 1 and in a subset of approximately 14 participants in Part 2 in order to enable estimation of PK parameters in approximately 22 participants receiving active treatment with varespladib.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study will be conducted in 2 parts. Both parts will be randomized and double-blind. Part 1 will be dose-finding in 4 parallel treatment groups randomized to treatment with varespladib (at 250 mg once daily [QD], twice daily [BID], or three times daily [TID] [total doses of 250, 500, or 750 mg/day]) or placebo in a 5:5:5:3 ratio. After all participants in Part 1 have completed Day 28, a data safety monitoring board (DSMB) will review the safety results from Part 1 and will recommend the dose regimen to be used in Part 2. Part 2 will randomize an additional 72 participants to the dose regimen selected from Part 1 or placebo in a 1:1 ratio.

In both parts of the study, eligible participants will be enrolled and randomized to receive either varespladib or placebo in addition to institutional standard of care for 7 days.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All participants, investigators, and study personnel involved in the conduct of the study, including data management, will be blinded to treatment assignment with the exception of a specified unblinded statistician, an unblinded pharmacist at each clinical site, a programmer from the contract research organization (CRO) who will have access to the randomization code, and the DSMB.
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Varespladib in Patients Hospitalized With Severe COVID 19 Caused by SARS-CoV-2
Actual Study Start Date : June 30, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022


Arm Intervention/treatment
Experimental: Varespladib: 250 mg QD
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Drug: Varespladib
250 mg immediate-release oblong, white, film-coated tablet for oral administration
Other Name: LY333013

Experimental: Varespladib: 250 mg BID
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Drug: Varespladib
250 mg immediate-release oblong, white, film-coated tablet for oral administration
Other Name: LY333013

Experimental: Varespladib: 250 mg TID
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Drug: Varespladib
250 mg immediate-release oblong, white, film-coated tablet for oral administration
Other Name: LY333013

Placebo Comparator: Placebo
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Drug: Placebo
Oral formulation matched to the oral varespladib tablet




Primary Outcome Measures :
  1. Proportion of participants alive and free of respiratory failure at Day 28 [ Time Frame: Baseline to Day 28 ]

    The proportion of respiratory failure-free surviving participants in each Part 2 treatment group at Day 28 will be analyzed using the Mantel-Haenszel stratum-weighted estimator with treatment as a factor. Respiratory failure is 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 because of resource limitation)


Secondary Outcome Measures :
  1. Proportion of subjects using HFNC within the first 28 days after randomization [ Time Frame: From randomization through Day 28 ]
    The proportion of subjects using HFNC within the first 28 days after randomization.

  2. Time to initiation of use of HFNC within the first 28 days after randomization [ Time Frame: From randomization through Day 28 ]
    Number of days to initiation of use of HFNC within the first 28 days after randomization.

  3. Duration of use of HFNC within the first 28 days after randomization [ Time Frame: From randomization through Day 28 ]
    Number of days of use of HFNC within the first 28 days after randomization.

  4. Proportion of subjects using noninvasive respiratory support within the first 28 days after randomization [ Time Frame: From randomization through Day 28 ]
    Proportion of subjects using noninvasive respiratory support within the first 28 days after randomization.

  5. Time to initiation of noninvasive respiratory support within the first 28 days after randomization [ Time Frame: From randomization through Day 28 ]
    Number of days to initiation of noninvasive respiratory support within the first 28 days after randomization.

  6. Duration of noninvasive respiratory support within the first 28 days after randomization [ Time Frame: From randomization through Day 28 ]
    Number of days of noninvasive respiratory support within the first 28 days after randomization.

  7. Proportion of subjects using mechanical ventilation within the first 28 days after randomization [ Time Frame: From randomization through Day 28 ]
    Proportion of subjects using mechanical ventilation within the first 28 days after randomization.

  8. Time to initiation of subjects using mechanical ventilation within the first 28 days after randomization [ Time Frame: From randomization through Day 28 ]
    Number of days to initiation of subjects using mechanical ventilation within the first 28 days after randomization.

  9. Duration of use by subjects of mechanical ventilation within the first 28 days after randomization [ Time Frame: From randomization through Day 28 ]
    Number of days of use by subjects of mechanical ventilation within the first 28 days after randomization.

  10. Number of days of oxygen support through Day 28 after randomization [ Time Frame: From randomization through Day 28 ]
    Number of days of oxygen support through Day 28 after randomization.

  11. SpO₂ through Day 28 after randomization [ Time Frame: From randomization through Day 28 ]
    Changes in SpO₂ (percentage) from randomization through Day 28.

  12. Proportion of participants remaining free of mechanical ventilation or ECMO throughout the 28 days after randomization [ Time Frame: From randomization through Day 28 ]
    Proportion of participants remaining free of mechanical ventilation or ECMO throughout the 28 days after randomization.

  13. Number of ventilator-free days through Day 28 after randomization [ Time Frame: From randomization through Day 28 ]
    Number of ventilator-free days through Day 28 after randomization.

  14. Number of hospitalization days through Day 28 after randomization [ Time Frame: From randomization through Day 28 ]
    Number of hospitalization days through Day 28 after randomization.

  15. Clinical status as measured by the World Health Organization (WHO) 9-point ordinal scale from baseline through Day 60 [ Time Frame: From baseline through Day 60 ]
    Changes from baseline in clinical status as measured by the WHO 9-point ordinal scale, where 0 = no clinical or virological evidence of infection and 8 = death

  16. Number of vasopressor-free days through Day 28 after randomization [ Time Frame: From randomization through Day 28 ]
    Number of vasopressor-free days through Day 28 after randomization.

  17. Number of days without renal stabilization and/or replacement through Day 28 after randomization [ Time Frame: From randomization through Day 28 ]
    Number of days without renal stabilization and/or replacement through Day 28 after randomization.

  18. Number of days at elevated level of care (ICU) through Day 28 after randomization [ Time Frame: From randomization through Day 28 ]
    Number of days at elevated level of care (ICU) through Day 28 after randomization.

  19. Number of healthcare encounters through Day 28 after randomization [ Time Frame: From randomization through Day 28 ]
    Number of healthcare encounters through Day 28 after randomization.

  20. Proportion of subjects with all-cause mortality through Day 60 [ Time Frame: From randomization through Day 60 ]
    Proportion of subjects who experience all-cause mortality from randomization through Day 60.

  21. Time to all-cause mortality through Day 60 [ Time Frame: From randomization through Day 60 ]
    Time to all-cause mortality for all subjects who experience the event from randomization through Day 60.

  22. Number of organ failure-free days through Day 28 after randomization [ Time Frame: From randomization through Day 28 ]
    Number of organ failure-free days through Day 28 after randomization.

  23. Incidence and severity of AEs, SAEs, and AEs leading to discontinuation of IP [ Time Frame: From providing informed consent through Day 60 ]
  24. Changes in vital signs: SpO₂ [ Time Frame: From providing informed consent through Day 60 ]
    Changes in SpO₂ (percentage) from providing informed consent through Day 60.

  25. Changes in vital signs: respiratory rate [ Time Frame: From providing informed consent through Day 60 ]
    Changes in respiratory rate (breaths per minute) from providing informed consent through Day 60.

  26. Changes in vital signs: body temperature [ Time Frame: From providing informed consent through Day 60 ]
    Changes in body temperature (degrees Celsius) from providing informed consent through Day 60.

  27. Changes in vital signs: heart rate [ Time Frame: From providing informed consent through Day 60 ]
    Changes in heartrate (beats per minute) from providing informed consent through Day 60.

  28. Changes in vital signs: blood pressure [ Time Frame: From providing informed consent through Day 60 ]
    Changes in blood pressure (systolic and diastolic blood pressure; mmHg) from providing informed consent through Day 60.

  29. Changes in levels of biomarkers: cardiac troponin [ Time Frame: From providing informed consent through Day 28 ]
    Changes in levels of cardiac troponin

  30. Changes in levels of biomarkers: C-reactive protein (CRP) [ Time Frame: From providing informed consent through Day 28 ]
    Changes in levels of CRP

  31. Changes in levels of biomarkers: D-dimer [ Time Frame: From providing informed consent through Day 28 ]
    Changes in levels of D-dimer

  32. Changes in levels of biomarkers: ferritin [ Time Frame: From providing informed consent through Day 28 ]
    Changes in levels of ferritin

  33. Changes in clinical laboratory evaluations: chemistry [ Time Frame: From providing informed consent through Day 28 ]
    The percentage of subjects with at least 1 post-baseline potentially clinically significant abnormality.

  34. Changes in clinical laboratory evaluations: coagulation [ Time Frame: From providing informed consent through Day 28 ]
    The percentage of subjects with at least 1 post-baseline potentially clinically significant abnormality.

  35. Changes in clinical laboratory evaluations: hematology [ Time Frame: From providing informed consent through Day 28 ]
    The percentage of subjects with at least 1 post-baseline potentially clinically significant abnormality.

  36. Changes in clinical laboratory evaluations: urinalysis [ Time Frame: From providing informed consent through Day 28 ]
    The percentage of subjects with at least 1 post-baseline potentially clinically significant abnormality.

  37. Changes in 12-lead ECGs [ Time Frame: From providing informed consent through Day 28 ]
    The percentage of subjects with an investigator interpretation of ECG results as abnormal clinically significant.


Other Outcome Measures:
  1. Participant-reported quality-of-life assessment using the 12-item Short Form Survey (SF-12) at Day 28 after randomization [ Time Frame: Day 28 ]
    Changes from baseline to Day 28 in SF-12 scores, which range from 0 to 100, with higher scores indicating better physical and mental health functioning.

  2. Activity of sPLA2 within blood samples collected as clinically required from treatment initiation to Day 28 after randomization [ Time Frame: From treatment initiation through Day 28 ]
    Changes in observed sPLA2 values

  3. Changes in PK parameters: area-under-the-curve (AUC) [ Time Frame: Day 1 through Day 3 ]
    Change in AUC from Day 1 through Day 3

  4. Changes in PK parameters: maximum concentration (Cmax) [ Time Frame: Day 1 through Day 3 ]
    Change in Cmax from Day 1 through Day 3

  5. Changes in PK parameters: time of Cmax (Tmax) [ Time Frame: Day 1 through Day 3 ]
    Change in Tmax from Day 1 through Day 3



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. Participant has a positive virologic nucleic acid amplification test (NAAT) indicating SARS-CoV-2 infection in a sample collected <72 hours prior to randomization.
  3. Participant is between the ages of 18 and 80 years at the time of enrollment.
  4. Participant provides informed consent prior to initiation of any study procedures.
  5. Participant agrees to not participate in another clinical trial for the treatment of COVID 19 or SARS-CoV-2 through Day 28.
  6. Participant has adequate hematologic status (in the absence of transfusion and growth factor support for at least 28 days), defined as follows:

    1. Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
    2. Platelet count ≥75 × 10⁹/L
    3. Hemoglobin ≥9 g/dL.
  7. Participant has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.

Exclusion Criteria:

  1. 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.

  2. Participant has taken investigational medications within 7 days or 5 half-lives prior to enrollment, whichever is shorter.
  3. 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.
  4. Has history of cerebrovascular accident or intracranial bleeding of any kind, acute coronary syndrome, myocardial infarction, or severe pulmonary hypertension.
  5. 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.
  6. Upper gastrointestinal (GI) bleed evidenced by hematemesis, "coffee-ground" emesis or nasogastric aspirate, or hematochezia thought to originate from upper GI tract.
  7. Participant has abnormal liver function defined as any 2 of the following at screening:

    1. Total bilirubin ≥2 × ULN
    2. Alanine aminotransferase (ALT) ≥3 × ULN
    3. Aspartate aminotransferase (AST) ≥3 × ULN
    4. Alkaline phosphatase (ALP) >3 × ULN
    5. Gamma-glutamyl transferase (GGT) >3 × ULN
  8. Participant has an estimated glomerular filtration rate (eGFR) <60 mL/min.
  9. Participant has a known allergy or significant adverse reaction to varespladib-methyl or related compounds.
  10. Participant is considered by the investigator to be unable to comply with protocol requirements due to geographic considerations, psychiatric disorders, or other compliance concerns; or has any serious medical condition or clinically significant laboratory, ECG, vital sign, or physical examination abnormality that would prevent study participation or place the participant at significant risk, as judged by the Investigator.
  11. Participant is breast-feeding, pregnant, has a positive serum hCG pregnancy test, or is not willing to use a highly effective method of contraception for 14 days after treatment. Highly effective methods of contraception are as follows:

    1. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
    2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
    3. Intrauterine device, intrauterine hormone-releasing system
    4. Bilateral tubal occlusion
    5. Vasectomized partner
    6. Sexual abstinence
    7. Double-barrier method (condoms, sponge, diaphragm, with spermicidal jellies, or cream).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969991


Contacts
Layout table for location contacts
Contact: Jeff Lickteig, MBA +1 331 401 1444 Jeffrey.Lickteig@premier-research.com

Locations
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United States, California
Ventura Clinical Trials Recruiting
Ventura, California, United States, 93003
Contact: Iliana Rojas    805-339-0549    irojas@venturaclinicaltrials.com   
Principal Investigator: Sabine Hazan         
United States, Florida
University of Miami Miller School of Medicine Not yet recruiting
Miami, Florida, United States, 33136
Contact: Priscilla Valls    786-300-7661    ptv7@med.miami.edu   
Contact: Jovanna Bertran-Lopez       jxb1803@med.miami.edu   
Principal Investigator: Folusakin Ayoade, MD         
Cordova Research Institute Not yet recruiting
Miami, Florida, United States, 33155
Contact: Yaquelin Rodriguez    786-554-2254    yrodriguez@cordovari.com   
Principal Investigator: Guillermo Somodevilla, MD         
Westchester Research Center at Westchester General Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Maria Bertoli    786-474-2612    maria.bertoli@westchesterhospital.com   
Principal Investigator: Jose David Suarez, MD         
United States, Indiana
Franciscan Alliance Not yet recruiting
Munster, Indiana, United States, 46321
Contact: Michelle Sheets    317-528-8756    Michelle.Sheets2@franciscanalliance.org   
Principal Investigator: Erica Kaufman-West         
United States, Massachusetts
The Brigham and Women's Hospital Emergency Medicine Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Guruprasad Jambaulikar       gjambaulikar@bwh.harvard.edu   
Principal Investigator: Peter Hou         
United States, Oklahoma
Ascension St. John Clinical Research Institute Not yet recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Anna Bryan, BSN, RN    918-744-3426    anna.bryan@ascension.org   
Principal Investigator: Anuj Malik, MD         
Sponsors and Collaborators
Ophirex, Inc.
Premier Research International LLC
Additional Information:
Publications:
Food and Drug Administration. Guidance for Industry on COVID-19: Developing Drugs and Biological Products for Treatment or Prevention, May 2020.

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Responsible Party: Ophirex, Inc.
ClinicalTrials.gov Identifier: NCT04969991    
Other Study ID Numbers: OPX-PR-02
W81XWH20C0066 ( Other Identifier: USA Medical Research Acquisition Activity )
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ophirex, Inc.:
acute respiratory distress syndrome
varespladib
LY333013
severe acute respiratory syndrome coronavirus 2
coronavirus disease 2019
ARDS
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Coronavirus Infections
Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Varespladib methyl
Phospholipase A2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action