Trial · NCT04404361

PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer

NCT04404361, Phase 2, Terminated, CTI BioPharma; results first posted 2024-06-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer. Trials, record NCT04404361. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04404361

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
NCT number: NCT04404361
Status: Terminated
Phases: Phase 2
Enrollment: 200 participants, actual
Lead sponsor: CTI BioPharma
Conditions: COVID19, COVID-19, COVID
Interventions: Pacritinib, Placebo
First posted: 2020-05-27
Last updated: 2024-06-05
Results first posted: 2024-06-05

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Progression to IMV and/or ECMO or Death	Baseline to Day 28	The percentage is calculated as the number of patients who progress to IMV/ECMO or death divided by the total number of patients in the ITT population (n/N \* 100).
Secondary	The Number of Ventilator-Free Days	Baseline to Day 28	the number of days that patients are alive and not intubated, from randomization to Day 28
Secondary	The Mortality Rate at Day 28	Baseline to Day 28	the number of patients with outcome of death during the 28 days following randomization
Secondary	The Mortality Rate at Day 15	Baseline to Day 15	the number of patients with outcome of death in the 15 days following randomization
Secondary	The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status	Baseline, Day 8, 15, 22, and 28.	Time to Improvement (days) = Date of improvement - Date of randomization + 1. Date of Improvement was defined as the time to first ordinal scale assessment 2 points or more lower than the baseline clinical status assessment.
Secondary	The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28	Baseline, Day 8, 15, 22, 28	Clinical status assessment based on the adapted scale from Cao et al. The patient CS is summarized by study visit. STATUS: 1. not hospitalized with resumption of normal activities; 2. not hospitalized but unable to resume normal activities; 3. hospitalization, not requiring supplemental oxygen; 4. hospitalization, requiring supplemental oxygen not meeting the criteria for categories 5 or 6; 5. hospitalization, on non-invasive positive pressure ventilation or high-flow nasal cannula; 6. hospitalization, requiring IMV and/or ECMO; 7. death.
Secondary	The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19	Baseline to Day 28	the proportion of patients reporting use of medications such as corticosteroids, tocilizumab, anakinra, or eculizumab as treatment for COVID-19, during 28 days following randomization

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Percentage of Participants With Progression to IMV and/or ECMO or Death	Baseline to Day 28	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Ventilator-Free Days	Baseline to Day 28	days	MEAN
SECONDARY	The Mortality Rate at Day 28	Baseline to Day 28	% of patients with outcome of death /D28	NUMBER
SECONDARY	The Mortality Rate at Day 15	Baseline to Day 15	% of patients with outcome of death /D15	NUMBER
SECONDARY	The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status	Baseline, Day 8, 15, 22, and 28.	days	MEDIAN
SECONDARY	The Clinical Status as Assessed by the 7-point Ordinal Scale of Clinical Status at Days 8, 15, 22, and 28	Baseline, Day 8, 15, 22, 28	participants	NUMBER
SECONDARY	The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19	Baseline to Day 28	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group76

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With Progression to IMV and/or ECMO or Death	Pacritinib and SOC	26		Participants
Percentage of Participants With Progression to IMV and/or ECMO or Death	Placebo and SOC	25		Participants
The Number of Ventilator-Free Days	Pacritinib and SOC	22.1	Standard Deviation 10.2	days
The Number of Ventilator-Free Days	Placebo and SOC	22.6	Standard Deviation 9.35	days
The Mortality Rate at Day 28	Pacritinib and SOC	10.1	95% Confidence Interval 5.0 to 17.8	% of patients with outcome of death /D28
The Mortality Rate at Day 28	Placebo and SOC	7.9	95% Confidence Interval 3.5 to 15.0	% of patients with outcome of death /D28
The Mortality Rate at Day 15	Pacritinib and SOC	5.1	95% Confidence Interval 1.7 to 11.4	% of patients with outcome of death /D15
The Mortality Rate at Day 15	Placebo and SOC	4.0	95% Confidence Interval 1.1 to 9.8	% of patients with outcome of death /D15
The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status	Pacritinib and SOC	9.0	95% Confidence Interval 8.0 to 10.0	days
The Time to Improvement by at Least 2 Points Relative to Baseline on the 7-point Ordinal Scale of Clinical Status	Placebo and SOC	9.0	95% Confidence Interval 7.0 to 11.0	days

1 to 10 of 76Source ClinicalTrials.gov

See all 76 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pacritinib and SOC	99
Overall Study	STARTED	Placebo and SOC	101
Overall Study	COMPLETED	Pacritinib and SOC	68
Overall Study	COMPLETED	Placebo and SOC	80
Overall Study	NOT COMPLETED	Pacritinib and SOC	31
Overall Study	NOT COMPLETED	Placebo and SOC	21

Source ClinicalTrials.gov

Adverse events66

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	Alanine aminotransferase increased	Hepatobiliary disorders	Pacritinib and SOC	15	96	17
other	Alanine aminotransferase increased	Hepatobiliary disorders	Placebo and SOC	17	101	19
other	anaemia	Blood and lymphatic system disorders	Pacritinib and SOC	12	96	12
other	anaemia	Blood and lymphatic system disorders	Placebo and SOC	18	101	18
other	bradycardia	Cardiac disorders	Pacritinib and SOC	15	96	15
other	bradycardia	Cardiac disorders	Placebo and SOC	11	101	11
other	constipation	Gastrointestinal disorders	Pacritinib and SOC	12	96	12
other	constipation	Gastrointestinal disorders	Placebo and SOC	13	101	13
other	hypokalaemia	Metabolism and nutrition disorders	Pacritinib and SOC	12	96	12
other	hypokalaemia	Metabolism and nutrition disorders	Placebo and SOC	12	101	17

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pacritinib and SOC	12	96
Total, all-cause mortality	Placebo and SOC	12	101
Total, other adverse events	Pacritinib and SOC	74	96
Total, other adverse events	Placebo and SOC	79	101
Total, serious adverse events	Pacritinib and SOC	20	96
Total, serious adverse events	Placebo and SOC	33	101

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36469321	DERIVED

Source PubMed

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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pacritinib and SOC vs Placebo and SOC: Percentage of Participants With Progression to IMV and/or ECMO or Death	Trial comparisons
Pacritinib and SOC vs Placebo and SOC: The Rate of Use of Immunomodulatory Agents as Treatment for COVID-19	Trial comparisons
Pacritinib and SOC vs Placebo and SOC: deaths from any cause	Trial comparisons
Pacritinib and SOC vs Placebo and SOC: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04404361

GET https://conductscience.org/api/trials/v1/NCT04404361/results?page=2

API reference For AI assistants