CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 32 enrolled
Drug / intervention
Anakinra +1 moredrug
Likely dose
Anakinra 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04362111
NCT04362111Phase 3Completed

Early Treatment of Cytokine Storm Syndrome in Covid-19

University of Alabama at Birmingham·interventional·Posted Apr 24, 2020·Updated Aug 24, 2023

In Brief

A Phase 3 clinical trial evaluating Anakinra and Normal saline for Cytokine Storm and COVID-19. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 24, 2020
Enrollment StartAug 1, 2020
Primary CompletionDec 31, 2021
Study CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.2 years ago

Interventions

Anakinradrug

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

Normal salinedrug

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