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Trial · NCT04575610

IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC)

NCT04575610, Phase 2, Terminated, Yale University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC). Trials, record NCT04575610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04575610

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Trial

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

Title
IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC)
NCT number
NCT04575610
Status
Terminated
Phases
Phase 2
Enrollment
7 participants, actual
Lead sponsor
Yale University
Conditions
COVID-19
Interventions
PF-06650833, Placebo
First posted
2020-10-05
Last updated
2021-10-26

Source ClinicalTrials.gov

Registered outcomes25

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

ListOutcomeTime frameDescription
PrimaryAll-cause mortality at Day 29Up to 29 daysAll-cause mortality at Day 29 (end of planned treatment period).
SecondaryDisease Severity (8 point scale)29 days
Proportion of patients alive, extubated, and receiving no more than low flow oxygen supplementation by nasal cannula or face mask (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 2 point decrease in the NIAID ordinal scale. The NIAID scale is as follows: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitations on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 5. Hospitalized, requiring supplemental oxygen 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices 7. Hospitalized, on invasive mechanical ventilation or ECMO 8. Death
SecondaryDisease Severity (8 point scale)61 days
Proportion of patients alive, extubated, and receiving no more than low flow oxygen supplementation by nasal cannula or face mask (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 2 point decrease in the NIAID ordinal scale (1 = not hospitalized, no limitations on activities, and 8 = death) at Day 61.
SecondaryDisease Severity (8 point scale)29 days
Proportion of patients alive, extubated, and receiving any level oxygen supplementation, including non-invasive positive pressure ventilation or high flow oxygen device (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 1-point decrease in the NIAID ordinal scale (1 = not hospitalized, no limitations on activities, and 8 = death) at Day 29.
SecondaryDisease Severity (8 point scale)61 days
Proportion of patients alive, extubated, and receiving any level oxygen supplementation, including non-invasive positive pressure ventilation or high flow oxygen device (excluding extubation for compassionate purposes in terminal patients). This would correspond to an at least 1-point decrease in the NIAID ordinal scale (1 = not hospitalized, no limitations on activities, and 8 = death) at Day 61.
SecondaryDisease Severity (8 point scale)8 days
Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity at Day 8. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day in which 1 = not hospitalized, no limitations on activities, and 8 = death.
SecondaryDisease Severity (8 point scale)15 days
Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity at Day 15. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day in which 1 = not hospitalized, no limitations on activities, and 8 = death.
SecondaryDisease Severity (8 point scale)22 days
Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity at Day 22. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day in which 1 = not hospitalized, no limitations on activities, and 8 = death.
SecondaryDisease Severity (8 point scale)29 days
Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity at Day 29. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day in which 1 = not hospitalized, no limitations on activities, and 8 = death.
SecondaryDisease Severity (8 point scale)61 days
Percentage of patients in each category of the NIAID 8-point ordinal scale of disease severity at Day 61. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day in which 1 = not hospitalized, no limitations on activities, and 8 = death.

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/NCT04575610

GET https://conductscience.org/api/trials/v1/NCT04575610/registered?page=2