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Trial · NCT04642950

A Phase II/III Study of Sargramostim

NCT04642950, Phase 2, Phase 3, Completed, Nobelpharma; results first posted 2024-07-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Phase II/III Study of Sargramostim. Trials, record NCT04642950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04642950

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Trial

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

Title
A Phase II/III Study of Sargramostim
NCT number
NCT04642950
Status
Completed
Phases
Phase 2, Phase 3
Enrollment
70 participants, actual
Lead sponsor
Nobelpharma
Conditions
COVID-19
Interventions
Sargramostim, Placebo
First posted
2020-11-24
Last updated
2024-07-19
Results first posted
2024-07-19

Source ClinicalTrials.gov

Registered outcomes4

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

ListOutcomeTime frameDescription
Primary2-rank Improvement on a 7-point Ordinal ScalePeriod until Day 28 (including the case after discharge).Number of days to achieve at least 2-rank improvement on a 7-point ordinal scale from baseline until Day 28.
SecondaryChanges From Baseline in Alveolar-arterial Oxygen Partial Pressure Gradient (A-aDO)Period until Day 28 (including the case after discharge).Changes from baseline in alveolar-arterial oxygen partial pressure gradient (A-aDO) on Day 5 and at the end of administration.
SecondaryNumber of Days Until Discharge From BaselinePeriod until Day 28 (including the case after discharge).Number of days until discharge from baseline (days of shifting to Category 7 on a 7-point ordinal scale).
SecondaryProportion of Subjects Whose Category Has Shifted to Category 1 or 2Period until Day 28 (including the case after discharge).Proportion of subjects whose category has shifted to Category 1 or 2 on a 7-point ordinal scale from baseline until Day 28

Outcomes4

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY2-rank Improvement on a 7-point Ordinal ScalePeriod until Day 28 (including the case after discharge).Number of DaysMEDIAN
SECONDARYChanges From Baseline in Alveolar-arterial Oxygen Partial Pressure Gradient (A-aDO)Period until Day 28 (including the case after discharge).
SECONDARYNumber of Days Until Discharge From BaselinePeriod until Day 28 (including the case after discharge).
SECONDARYProportion of Subjects Whose Category Has Shifted to Category 1 or 2Period until Day 28 (including the case after discharge).

Results by group2

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

OutcomeGroupCategoryValueSpreadUnits
2-rank Improvement on a 7-point Ordinal ScaleNPC-26995% Confidence Interval 8 to 9Number of Days
2-rank Improvement on a 7-point Ordinal ScaleNP-26 Placebo895% Confidence Interval 7 to 10Number of Days

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDNPC-2647
Overall StudySTARTEDNP-26 Placebo23
Overall StudyCOMPLETEDNPC-2644
Overall StudyCOMPLETEDNP-26 Placebo23
Overall StudyNOT COMPLETEDNPC-263
Overall StudyNOT COMPLETEDNP-26 Placebo0

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherConstipationGastrointestinal disordersNPC-26747
otherConstipationGastrointestinal disordersNP-26 Placebo423
otherHepatocellular injuryHepatobiliary disordersNPC-26347
otherHepatocellular injuryHepatobiliary disordersNP-26 Placebo023
otherWhite blood cell count increasedInvestigationsNPC-26747
otherWhite blood cell count increasedInvestigationsNP-26 Placebo023
otherHyperglycemiaMetabolism and nutrition disordersNPC-26447
otherHyperglycemiaMetabolism and nutrition disordersNP-26 Placebo123
otherInsomniaPsychiatric disordersNPC-26147
otherInsomniaPsychiatric disordersNP-26 Placebo323

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityNPC-26047
Total, all-cause mortalityNP-26 Placebo023
Total, other adverse eventsNPC-262247
Total, other adverse eventsNP-26 Placebo823
Total, serious adverse eventsNPC-26247
Total, serious adverse eventsNP-26 Placebo023

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
37729076DERIVED

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 comparisons2

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

ComparisonSource
NPC-26 vs NP-26 Placebo: deaths from any causeTrial comparisons
NPC-26 vs NP-26 Placebo: serious adverse eventsTrial 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/NCT04642950

GET https://conductscience.org/api/trials/v1/NCT04642950/registered