Trial · NCT04339712

Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction

NCT04339712, Phase 2, Completed, Hellenic Institute for the Study of Sepsis

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction. Trials, record NCT04339712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04339712

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Trial

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

Title: Personalised Immunotherapy for SARS-CoV-2 (COVID-19) Associated With Organ Dysfunction
NCT number: NCT04339712
Status: Completed
Phases: Phase 2
Enrollment: 102 participants, actual
Lead sponsor: Hellenic Institute for the Study of Sepsis
Conditions: COVID-19, Virus Diseases, Macrophage Activation Syndrome, Corona Virus Infection
Interventions: Anakinra, Tocilizumab
First posted: 2020-04-09
Last updated: 2021-01-11
Other registries' IDs: eudract:2020-001039-29

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Change of baseline total sequential organ failure assessment (SOFA) score	Visit study day 8	At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8
Primary	Improvement of lung involvement measurements	Visit study day 8	Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8
Primary	Increase of pO2/FiO2 ratio	Visit Study Day 8	At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8
Secondary	Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators	Screening, Day 8	Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Secondary	Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators	Screening, Day 8	Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Secondary	Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators	Screening, Day 8	Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database
Secondary	Change of sequential organ failure assessment (SOFA) score	Day 28	Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Secondary	Rate of Mortality	Day 28	Mortality on day 28
Secondary	Rate of Mortality	Day 90	Mortality on day 90
Secondary	Cytokine stimulation	Screening, Day 4	Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes0

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

None in this release.

Results by group0

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

None in this release.

Participant flow0

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

None in this release.

Adverse events0

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

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

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/NCT04339712

GET https://conductscience.org/api/trials/v1/NCT04339712/registered

API reference For AI assistants