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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 2-rank Improvement on a 7-point Ordinal Scale | Period 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. |
| Secondary | Changes 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. |
| Secondary | Number of Days Until Discharge From Baseline | Period 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). |
| Secondary | Proportion of Subjects Whose Category Has Shifted to Category 1 or 2 | Period 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 2-rank Improvement on a 7-point Ordinal Scale | Period until Day 28 (including the case after discharge). | Number of Days | MEDIAN | |
| SECONDARY | Changes From Baseline in Alveolar-arterial Oxygen Partial Pressure Gradient (A-aDO) | Period until Day 28 (including the case after discharge). | |||
| SECONDARY | Number of Days Until Discharge From Baseline | Period until Day 28 (including the case after discharge). | |||
| SECONDARY | Proportion of Subjects Whose Category Has Shifted to Category 1 or 2 | Period until Day 28 (including the case after discharge). |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 2-rank Improvement on a 7-point Ordinal Scale | NPC-26 | 9 | 95% Confidence Interval 8 to 9 | Number of Days | |
| 2-rank Improvement on a 7-point Ordinal Scale | NP-26 Placebo | 8 | 95% Confidence Interval 7 to 10 | Number of Days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NPC-26 | 47 | |
| Overall Study | STARTED | NP-26 Placebo | 23 | |
| Overall Study | COMPLETED | NPC-26 | 44 | |
| Overall Study | COMPLETED | NP-26 Placebo | 23 | |
| Overall Study | NOT COMPLETED | NPC-26 | 3 | |
| Overall Study | NOT COMPLETED | NP-26 Placebo | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Constipation | Gastrointestinal disorders | NPC-26 | 7 | 47 | |
| other | Constipation | Gastrointestinal disorders | NP-26 Placebo | 4 | 23 | |
| other | Hepatocellular injury | Hepatobiliary disorders | NPC-26 | 3 | 47 | |
| other | Hepatocellular injury | Hepatobiliary disorders | NP-26 Placebo | 0 | 23 | |
| other | White blood cell count increased | Investigations | NPC-26 | 7 | 47 | |
| other | White blood cell count increased | Investigations | NP-26 Placebo | 0 | 23 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | NPC-26 | 4 | 47 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | NP-26 Placebo | 1 | 23 | |
| other | Insomnia | Psychiatric disorders | NPC-26 | 1 | 47 | |
| other | Insomnia | Psychiatric disorders | NP-26 Placebo | 3 | 23 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NPC-26 | 0 | 47 |
| Total, all-cause mortality | NP-26 Placebo | 0 | 23 |
| Total, other adverse events | NPC-26 | 22 | 47 |
| Total, other adverse events | NP-26 Placebo | 8 | 23 |
| Total, serious adverse events | NPC-26 | 2 | 47 |
| Total, serious adverse events | NP-26 Placebo | 0 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37729076 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NPC-26 vs NP-26 Placebo: deaths from any cause | Trial comparisons |
| NPC-26 vs NP-26 Placebo: 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.
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