Early Treatment of Cytokine Storm Syndrome in Covid-19
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|ClinicalTrials.gov Identifier: NCT04362111|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : April 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cytokine Storm COVID-19||Drug: Anakinra Drug: Normal saline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two parallel treatment arms|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Investigator, care provider, and participant blinded|
|Official Title:||Early Treatment of Cytokine Storm Syndrome in Covid-19|
|Actual Study Start Date :||July 29, 2020|
|Actual Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Anakinra Group
The active treatment group will receive anakinra 100 mg subcutaneously every 6 hours for period of 10 days. For subjects meeting complete response criteria at 5 days, dosing will be decreased to 100 mg twice daily for the remaining 5 days.
The active treatment group will receive anakinra 100 mg subcutaneously every 6-12 hours for a period of 10 days
Other Name: recombinant human IL-ra (rhIL-1ra)
Placebo Comparator: Control Group
The control group will receive normal saline placebo subcutaneously every 6 hours for period of 10 days. For subjects meeting complete repsonse criteria at 5 days, dosing wll be decreased to twice daily for the remaining 5 days.
Drug: Normal saline
The control group will receive normal saline placebo subcutaneously every 6-12 hours for period of 10 days
Other Name: NS
- Percentage of patients discharged from the hospital alive and without the need for mechanical ventilation. [ Time Frame: Variable up to Day 28 ]Percentage of subjects discharged from hospital without the need for intubation and mechanical ventilation
- Percentage of subjects with 25% change (decrease) in cytokine storm markers at 48 hours [ Time Frame: 48 hours ]25% change (decrease) in noted baseline elevations of serum ferritin, LDH, CRP, and d-dimer.
- Percentage of subjects without increase in oxygen requirement and no increase in oxygen delivery/respiratory support measures after 48 hours. [ Time Frame: 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)
- Average time in days to achieve sustained ≥93% oxygen saturation without oxygen/respiratory support [ Time Frame: 0-10 days ]Time from initial dosing of IP to achievement of ≥93% oxygen saturation on room air for 24 hours
- Percentage of subjects with resolution of laboratory markers of Cytokine Storm syndrome [ Time Frame: Day 10 ]Normalization or ≥ 75% improvement by Day 10 (120 hours) in each of the following laboratory CSS attributes elevated beyond the normal range at randomization: ferritin, fibrinogen, AST, ALT, leucopenia, thrombocytopenia, d-dimer, CRP, triglycerides, sCD25.
- Percentage of subjects who develop bacterial or fungal or non-Covid-19 viral infection [ Time Frame: Day 0-28 ]No increased prevalence of bacterial or fungal or viral infection through the time of hospital discharge until Day 28.
- Percentage of subjects who develop neutralizing antibody to Covid-19 [ Time Frame: Day 28 ]No failure to develop neutralizing antibody to Covid-19 measured at Day 28.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362111
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Walter W Chatham, MD||University of Alabama at Birmingham|