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Early Treatment of Cytokine Storm Syndrome in Covid-19

NCT04362111 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-08-24

Study results available
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Summary

This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.

Conditions

Interventions

DRUG

Anakinra

The active treatment group will receive anakinra 100 mg subcutaneously every 6-12 hours for a period of 10 days

DRUG

Normal saline

The control group will receive normal saline placebo subcutaneously every 6-12 hours for period of 10 days

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Walter W Chatham, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-12-31
Completion
2023-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04362111 on ClinicalTrials.gov