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Interleukin-1 (IL-1) Receptor Antagonist

Anakinra Group for Coronavirus

Phase 3
Waitlist Available
Led By Walter W Chatham, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2 (48 hours)-day 10 (240 hours)
Awards & highlights

Study Summary

This trial will test if an experimental drug can help prevent respiratory failure in patients with Covid-19 who are at risk for developing CSS.

Eligible Conditions
  • Coronavirus
  • Cytokine Storm
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2 (48 hours)-day 10 (240 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 (48 hours)-day 10 (240 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation.
Secondary outcome measures
Absence of Supplemental Oxygen Requirement at Day 10
Patients Requiring Minimal Oxygen Support at Day 10
Percentage of Subjects Who Develop Bacterial or Fungal or Non-Covid-19 Viral Infection
+3 more

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132
19%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Anakinra GroupExperimental Treatment1 Intervention
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.
Group II: Control GroupPlacebo Group1 Intervention
The control group will receive normal saline placebo subcutaneously every 6 hours for period of 10 days. For subjects meeting complete response criteria at 5 days, dosing will be decreased to twice daily for the remaining 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
2016
Completed Phase 4
~2240

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,578 Previous Clinical Trials
2,274,880 Total Patients Enrolled
Walter W Chatham, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions typically necessitate Anakinra Group as a form of treatment?

"Anakinra Group is typically employed to treat systemic juvenile idiopathic arthritis (sjia) and other syndromes such as neonatal-onset multisystem inflammatory disease (nomid), interleukin-1 receptors, and steroidal treatments."

Answered by AI

What is the cap on enrolment for this research study?

"Unfortunately, this research effort is not actively admitting new participants. The trial was initially published on July 29th 2020 and the latest update occurred on November 16th 2022. For those searching for available trials, there are 1046 studies currently enrolling individuals suffering from Covid-19 and 33 clinical studies looking to include patients in the Anakinra Group."

Answered by AI

Is eligibility for this experiment restricted to persons over the age of twenty?

"To qualify for this trial, the applicant must be within 18-80 years old. There are 148 trials specifically designed to treat patients below the age of majority and 940 that cater towards those above 65 years old."

Answered by AI

Is this research project searching for more volunteers?

"Unfortunately, this clinical trial is no longer welcoming new recruits. It was initially advertised on July 29th 2020 and the last update occurred November 16th 2020. Alternately, 1046 studies are currently recruiting patients with Covid-19 whereas 33 trials require participants for Anakinra Group research."

Answered by AI

What criteria must a participant fulfill to qualify for this investigation?

"To be eligible for this particular clinical trial, potential participants must currently have covid-19 and fall between the ages of 18 to 80. This study will accept roughly 15 new patients."

Answered by AI

How efficacious is the Anakinra Group in terms of patient safety?

"Our team at Power evaluated anakinra group's safety and determined it to be 3 out of 3 due to the pre-existing data that attests to both its efficacy and protective measures."

Answered by AI

Has research previously been conducted on Anakinra Group?

"Currently, there are 33 ongoing clinical trials researching Anakinra Group with 7 of those in Phase 3. These studies have a presence spanning across 440 medical centres worldwide, having a particular concentration in Paris and the Ile-De-France region."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Early Treatment of Cytokine Storm Syndrome in Covid-19
W Winn Chatham 2020. "Early Treatment of Cytokine Storm Syndrome in Covid-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04362111.
~7 spots leftby Apr 2025
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