Trial · NCT04362111
Early Treatment of Cytokine Storm Syndrome in Covid-19
NCT04362111, Phase 3, Completed, University of Alabama at Birmingham; results first posted 2023-08-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Early Treatment of Cytokine Storm Syndrome in Covid-19. Trials, record NCT04362111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04362111
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Treatment of Cytokine Storm Syndrome in Covid-19
- NCT number
- NCT04362111
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 32 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Cytokine Storm, COVID-19
- Interventions
- Anakinra, Normal saline
- First posted
- 2020-04-24
- Last updated
- 2023-08-24
- Results first posted
- 2023-08-24
- Limitations and caveats
1. All subjects received daily dexamethasone to the standard of care management of Covid-19 pneumonia requiring hospitalization.~2. Some of the enrolled subjects with rapid improvement were discharged prior to 10 days with instructions on anakinra self-administration at home; adherence with unsupervised dosing of study agent could not be readily assessed, nor could reported oxygen saturations be confirmed in these participants.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation. | Variable up to Day 28 | Percentage of subjects discharged from hospital alive and who did not require intubation and mechanical ventilation |
| Secondary | Percentage of Subjects With 25% Change (Decrease) in Cytokine Storm Markers at 48-72 Hours After Dosing With Study Agent | 48 hours after taking initial dose of anakinra/placebo | 25% change (decrease) in noted baseline elevations of serum ferritin and CRP measured 48-72 hours after following initial dosing of anakinra/placebo. |
| Secondary | Percentage of Subjects Without Increase in Oxygen Requirement and no Increase in Oxygen Delivery/Respiratory Support Measures After 48 Hours. | Day 2 (48 hours)-Day 10 (240 hours) | Supplemental oxygen requirement to maintain oxygen saturation \>90% stable or decreased without escalation of respiratory support measures (addition of CPAP, initiation of mechanical ventilation) |
| Secondary | Patients Requiring Minimal Oxygen Support at Day 10 | 0-10 days | Percentage of participants requiring no more than 2 L/min nasal canula oxygen to maintain oxygen saturation \>93% by Day 10 |
| Secondary | Percentage of Subjects With Resolution of Laboratory Markers of Cytokine Storm Syndrome | Day 10 | Normalization or ≥ 75% improvement by Day 10 (120 hours) in each (all) of the following laboratory CSS attributes elevated beyond the normal range at randomization: ferritin, d-dimer, CRP, and LDH. |
| Secondary | Percentage of Subjects Who Develop Bacterial or Fungal or Non-Covid-19 Viral Infection | Day 0-28 | Occurence of new bacterial or fungal or viral infection through the time of hospital discharge or Day 28. |
| Secondary | Absence of Supplemental Oxygen Requirement at Day 10 | 0-10 Days | Percentage of participants able to maintain oxygen saturation \>93% on room air by Day 10 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation. | Variable up to Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With 25% Change (Decrease) in Cytokine Storm Markers at 48-72 Hours After Dosing With Study Agent | 48 hours after taking initial dose of anakinra/placebo | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects Without Increase in Oxygen Requirement and no Increase in Oxygen Delivery/Respiratory Support Measures After 48 Hours. | Day 2 (48 hours)-Day 10 (240 hours) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patients Requiring Minimal Oxygen Support at Day 10 | 0-10 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Resolution of Laboratory Markers of Cytokine Storm Syndrome | Day 10 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects Who Develop Bacterial or Fungal or Non-Covid-19 Viral Infection | Day 0-28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Absence of Supplemental Oxygen Requirement at Day 10 | 0-10 Days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation. | Anakinra Group | 10 | Participants | ||
| Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation. | Control Group | 10 | Participants | ||
| Percentage of Subjects With 25% Change (Decrease) in Cytokine Storm Markers at 48-72 Hours After Dosing With Study Agent | Anakinra Group | 6 | Participants | ||
| Percentage of Subjects With 25% Change (Decrease) in Cytokine Storm Markers at 48-72 Hours After Dosing With Study Agent | Control Group | 8 | Participants | ||
| Percentage of Subjects Without Increase in Oxygen Requirement and no Increase in Oxygen Delivery/Respiratory Support Measures After 48 Hours. | Anakinra Group | 8 | Participants | ||
| Percentage of Subjects Without Increase in Oxygen Requirement and no Increase in Oxygen Delivery/Respiratory Support Measures After 48 Hours. | Control Group | 9 | Participants | ||
| Patients Requiring Minimal Oxygen Support at Day 10 | Anakinra Group | 8 | Participants | ||
| Patients Requiring Minimal Oxygen Support at Day 10 | Control Group | 9 | Participants | ||
| Percentage of Subjects With Resolution of Laboratory Markers of Cytokine Storm Syndrome | Anakinra Group | 0 | Participants | ||
| Percentage of Subjects With Resolution of Laboratory Markers of Cytokine Storm Syndrome | Control Group | 7 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anakinra Group | 15 | |
| Overall Study | STARTED | Control Group | 17 | |
| Overall Study | COMPLETED | Anakinra Group | 15 | |
| Overall Study | COMPLETED | Control Group | 15 | |
| Overall Study | NOT COMPLETED | Anakinra Group | 0 | |
| Overall Study | NOT COMPLETED | Control Group | 2 |
Source ClinicalTrials.gov
Adverse events16
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 | Venous thrombosis | Blood and lymphatic system disorders | Anakinra Group | 4 | 15 | 4 |
| other | Venous thrombosis | Blood and lymphatic system disorders | Control Group | 3 | 15 | 3 |
| other | Acute Renal Failure | Renal and urinary disorders | Anakinra Group | 7 | 15 | 7 |
| other | Acute Renal Failure | Renal and urinary disorders | Control Group | 6 | 15 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | Anakinra Group | 1 | 15 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Control Group | 0 | 15 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Anakinra Group | 14 | 15 | 14 |
| other | Anemia | Blood and lymphatic system disorders | Control Group | 13 | 15 | 13 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Anakinra Group | 5 | 15 | 5 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Control Group | 5 | 15 | 5 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anakinra Group | 4 | 15 |
| Total, all-cause mortality | Control Group | 4 | 15 |
| Total, other adverse events | Anakinra Group | 14 | 15 |
| Total, other adverse events | Control Group | 13 | 15 |
| Total, serious adverse events | Anakinra Group | 9 | 15 |
| Total, serious adverse events | Control Group | 7 | 15 |
Source ClinicalTrials.gov
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anakinra Group vs Control Group: Percentage of Subjects Who Develop Bacterial or Fungal or Non-Covid-19 Viral Infection | Trial comparisons |
| Anakinra Group vs Control Group: Percentage of Subjects With 25% Change (Decrease) in Cytokine Storm Markers at 48-72 Hours After Dosing With Study Agent | Trial comparisons |
| Anakinra Group vs Control Group: Patients Requiring Minimal Oxygen Support at Day 10 | Trial comparisons |
| Anakinra Group vs Control Group: Percentage of Subjects With Resolution of Laboratory Markers of Cytokine Storm Syndrome | Trial comparisons |
| Anakinra Group vs Control Group: Percentage of Subjects Without Increase in Oxygen Requirement and no Increase in Oxygen Delivery/Respiratory Support Measures After 48 Hours. | Trial comparisons |
| Anakinra Group vs Control Group: Absence of Supplemental Oxygen Requirement at Day 10 | Trial comparisons |
| Anakinra Group vs Control Group: Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation. | Trial comparisons |
| Anakinra Group vs Control Group: deaths from any cause | Trial comparisons |
| Anakinra Group vs Control Group: 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/NCT04362111
GET https://conductscience.org/api/trials/v1/NCT04362111/registered