Trial · NCT04969991
Study of Varespladib in Patients Hospitalized With Severe COVID-19
NCT04969991, Phase 2, Terminated, Ophirex, Inc.; results first posted 2025-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Varespladib in Patients Hospitalized With Severe COVID-19. Trials, record NCT04969991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04969991
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Varespladib in Patients Hospitalized With Severe COVID-19
- NCT number
- NCT04969991
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Ophirex, Inc.
- Conditions
- Coronavirus Disease 2019, Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
- Interventions
- Varespladib, Placebo
- First posted
- 2021-07-21
- Last updated
- 2025-05-15
- Results first posted
- 2025-05-15
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Alive and Free of Respiratory Failure at Day 28 | 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 | Proportion of Subjects Using HFNC Within the First 28 Days After Randomization | From randomization through Day 28 | The proportion of subjects using HFNC within the first 28 days after randomization. |
| Secondary | Proportion of Subjects Using Noninvasive Respiratory Support Within the First 28 Days After Randomization | From randomization through Day 28 | Proportion of subjects using noninvasive respiratory support within the first 28 days after randomization. |
| Secondary | Proportion of Subjects Using Mechanical Ventilation Within the First 28 Days After Randomization | From randomization through Day 28 | Proportion of subjects using mechanical ventilation within the first 28 days after randomization. |
| Secondary | Number of Days of Oxygen Support Through Day 28 After Randomization | From randomization through Day 28 | Number of days of oxygen support through Day 28 after randomization. |
| Secondary | Proportion of Participants Remaining Free of Mechanical Ventilation or ECMO Throughout the 28 Days After Randomization | From randomization through Day 28 | Proportion of participants remaining free of mechanical ventilation or ECMO throughout the 28 days after randomization. |
| Secondary | Proportion of Subjects With All-cause Mortality Through Day 60 | From randomization through Day 60 | Proportion of subjects who experience all-cause mortality from randomization through Day 60. |
| Secondary | Number of Participants With Change in Body Temperature | From providing informed consent through Day 60 | Number of participants with change in body temperature from providing informed consent through Day 60. |
| Other | Participant-reported Quality-of-life Assessment Using the 12-item Short Form Survey (SF-12) at Day 28 After Randomization | 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. |
| Other | Activity of sPLA2 Within Blood Samples Collected as Clinically Required From Treatment Initiation to Day 28 After Randomization | From treatment initiation through Day 28 | Changes in observed sPLA2 values |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants Alive and Free of Respiratory Failure at Day 28 | Baseline to Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Subjects Using HFNC Within the First 28 Days After Randomization | From randomization through Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Subjects Using Noninvasive Respiratory Support Within the First 28 Days After Randomization | From randomization through Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Subjects Using Mechanical Ventilation Within the First 28 Days After Randomization | From randomization through Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Days of Oxygen Support Through Day 28 After Randomization | From randomization through Day 28 | days | MEAN | |
| SECONDARY | Proportion of Participants Remaining Free of Mechanical Ventilation or ECMO Throughout the 28 Days After Randomization | From randomization through Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Subjects With All-cause Mortality Through Day 60 | From randomization through Day 60 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Change in Body Temperature | From providing informed consent through Day 60 | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Participant-reported Quality-of-life Assessment Using the 12-item Short Form Survey (SF-12) at Day 28 After Randomization | Day 28 | |||
| OTHER_PRE_SPECIFIED | Activity of sPLA2 Within Blood Samples Collected as Clinically Required From Treatment Initiation to Day 28 After Randomization | From treatment initiation through Day 28 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants Alive and Free of Respiratory Failure at Day 28 | Varespladib: 250 mg QD + Placebo + Placebo | 4 | Participants | ||
| Proportion of Participants Alive and Free of Respiratory Failure at Day 28 | Varespladib: 250 mg BID + Placebo | 4 | Participants | ||
| Proportion of Participants Alive and Free of Respiratory Failure at Day 28 | Varespladib: 250 mg TID | 3 | Participants | ||
| Proportion of Participants Alive and Free of Respiratory Failure at Day 28 | Placebo | 3 | Participants | ||
| Proportion of Subjects Using HFNC Within the First 28 Days After Randomization | Varespladib: 250 mg QD + Placebo + Placebo | 0 | Participants | ||
| Proportion of Subjects Using HFNC Within the First 28 Days After Randomization | Varespladib: 250 mg BID + Placebo | 1 | Participants | ||
| Proportion of Subjects Using HFNC Within the First 28 Days After Randomization | Varespladib: 250 mg TID | 2 | Participants | ||
| Proportion of Subjects Using HFNC Within the First 28 Days After Randomization | Placebo | 0 | Participants | ||
| Proportion of Subjects Using Noninvasive Respiratory Support Within the First 28 Days After Randomization | Varespladib: 250 mg QD + Placebo + Placebo | 1 | Participants | ||
| Proportion of Subjects Using Noninvasive Respiratory Support Within the First 28 Days After Randomization | Varespladib: 250 mg BID + Placebo | 1 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Varespladib: 250 mg QD + Placebo + Placebo | 5 | |
| Part 1 | STARTED | Varespladib: 250 mg BID + Placebo | 5 | |
| Part 1 | STARTED | Varespladib: 250 mg TID | 5 | |
| Part 1 | STARTED | Placebo | 3 | |
| Part 1 | COMPLETED | Varespladib: 250 mg QD + Placebo + Placebo | 4 | |
| Part 1 | COMPLETED | Varespladib: 250 mg BID + Placebo | 4 | |
| Part 1 | COMPLETED | Varespladib: 250 mg TID | 5 | |
| Part 1 | COMPLETED | Placebo | 3 | |
| Part 1 | NOT COMPLETED | Varespladib: 250 mg QD + Placebo + Placebo | 1 | |
| Part 1 | NOT COMPLETED | Varespladib: 250 mg BID + Placebo | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | Cardiac disorders | Varespladib: 250 mg QD + Placebo + Placebo | 0 | 5 | 0 |
| other | Hypotension | Cardiac disorders | Varespladib: 250 mg BID + Placebo | 1 | 5 | 1 |
| other | Hypotension | Cardiac disorders | Varespladib: 250 mg TID | 0 | 5 | 0 |
| other | Hypotension | Cardiac disorders | Placebo | 0 | 3 | 0 |
| other | Transaminases Increased | Hepatobiliary disorders | Varespladib: 250 mg QD + Placebo + Placebo | 0 | 5 | 0 |
| other | Transaminases Increased | Hepatobiliary disorders | Varespladib: 250 mg BID + Placebo | 1 | 5 | 1 |
| other | Transaminases Increased | Hepatobiliary disorders | Varespladib: 250 mg TID | 0 | 5 | 0 |
| other | Transaminases Increased | Hepatobiliary disorders | Placebo | 0 | 3 | 0 |
| serious | Progression of COVID 19 | Infections and infestations | Varespladib: 250 mg QD + Placebo + Placebo | 1 | 5 | 1 |
| serious | Progression of COVID 19 | Infections and infestations | Varespladib: 250 mg BID + Placebo | 0 | 5 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varespladib: 250 mg QD + Placebo + Placebo | 1 | 5 |
| Total, all-cause mortality | Varespladib: 250 mg BID + Placebo | 0 | 5 |
| Total, all-cause mortality | Varespladib: 250 mg TID | 0 | 5 |
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, other adverse events | Varespladib: 250 mg QD + Placebo + Placebo | 0 | 5 |
| Total, other adverse events | Varespladib: 250 mg BID + Placebo | 2 | 5 |
| Total, other adverse events | Varespladib: 250 mg TID | 0 | 5 |
| Total, other adverse events | Placebo | 0 | 3 |
| Total, serious adverse events | Varespladib: 250 mg QD + Placebo + Placebo | 1 | 5 |
| Total, serious adverse events | Varespladib: 250 mg BID + Placebo | 1 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04969991
GET https://conductscience.org/api/trials/v1/NCT04969991/results?page=2