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NCT04642950

A Phase II/III Study of Sargramostim

Completed Phase 2, PHASE3 Results posted Last updated 19 July 2024
What this trial tests

Phase 2, PHASE3 trial testing Sargramostim in COVID-19 in 70 participants. Completed in 25 October 2021.

Timeline
17 December 2020
Primary endpoint
25 October 2021
25 October 2021

Quick facts

Lead sponsorNobelpharma
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment70
Start date17 December 2020
Primary completion25 October 2021
Estimated completion25 October 2021
Sites7 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Nobelpharma — full company profile →

Who can join

Adults 20 to 85, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

2-rank Improvement on a 7-point Ordinal Scale Primary · 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.

GroupValue95% CI
NPC-2698 – 9
NP-26 Placebo87 – 10

Adverse events — posted to ClinicalTrials.gov

Time frame: Day1-28. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NPC-26
Serious: 2/47 (4%)
Deaths: 0/47
NP-26 Placebo
Serious: 0/23 (0%)
Deaths: 0/23

Serious adverse events (2 terms)

ReactionSystemNPC-26NP-26 Placebo
Myocardial infarctionCardiac disorders
COVID-19 pneumoniaInfections and infestations
Other adverse events (5 terms — click to expand)

ReactionSystemNPC-26NP-26 Placebo
ConstipationGastrointestinal disorders
White blood cell count increasedInvestigations
HyperglycemiaMetabolism and nutrition disorders
Hepatocellular injuryHepatobiliary disorders
InsomniaPsychiatric disorders

Most-reported serious reactions: Myocardial infarction, COVID-19 pneumonia.

Data from ClinicalTrials.gov NCT04642950 adverse events section.

Sponsor's own description

This is a randomized, placebo-controlled, double-blind, group comparison, multicenter study to evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment in COVID-19 patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
    Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
  2. A roadmap to pulmonary delivery strategies for the treatment of infectious lung diseases.
    He S, Gui J, Xiong K, Chen M, et al · · 2022 · cited 91× · PMID 35241085 · DOI 10.1186/s12951-022-01307-x
  3. Sargramostim (rhu GM-CSF) as Cancer Therapy (Systematic Review) and An Immunomodulator. A Drug Before Its Time?
    Lazarus HM, Ragsdale CE, Gale RP, Lyman GH. · · 2021 · cited 53× · PMID 34484202 · DOI 10.3389/fimmu.2021.706186
  4. Inflammatory pathways in COVID-19: Mechanism and therapeutic interventions.
    Jiang Y, Zhao T, Zhou X, Xiang Y, et al · · 2022 · cited 44× · PMID 35923762 · DOI 10.1002/mco2.154
  5. GM-CSF: Orchestrating the Pulmonary Response to Infection.
    McCormick TS, Hejal RB, Leal LO, Ghannoum MA. · · 2021 · cited 23× · PMID 35111042 · DOI 10.3389/fphar.2021.735443
  6. Host-Based Treatments for Severe COVID-19.
    Mondini L, Salton F, Trotta L, Bozzi C, et al · · 2023 · cited 3× · PMID 37185727 · DOI 10.3390/cimb45040203
  7. Short-term inhalation of sargramostim with concomitant high-dose steroids does not hasten recovery in moderate COVID-19 pneumonia: a double-blind, randomised, placebo-controlled trial.
    Shimasaki S, Baba T, Ogura T, Akasaka K, et al · · 2023 · cited 2× · PMID 37729076 · DOI 10.1080/23744235.2023.2254380
  8. Early treatment with inhaled GM-CSF improves oxygenation and anti-viral immunity in COVID-19 induced lung injury – a randomized clinical trial
    Bosteels C, Damme KV, De Leeuw E, Declercq J, et al · · 2021 · DOI 10.21203/rs.3.rs-959220/v1

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