CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 606 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/NCT04680949
NCT04680949Phase 3Completed
CompareCT.gov

suPAR-Guided Anakinra Treatment for Validation of the Risk and Early Management of Severe Respiratory Failure by COVID-19: The SAVE-MORE Double-blind, Randomized, Phase III Confirmatory Trial

Hellenic Institute for the Study of Sepsis·interventional·Posted Dec 23, 2020·Updated Sep 6, 2022

In Brief

A Phase 3 clinical trial evaluating Anakinra and Placebo for Covid19. Completed, enrolled 606 participants across 40 sites in 2 countries.

Detailed Summary

The SAVE-MORE is a pivotal, confirmatory, phase III randomized clinical trial (RCT) aiming to evaluate the efficacy and safety of early start of anakinra guided by suPAR in patients with LRTI by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days as measured by the ordinal scale of the 11-point World Health Organization (WHO) clinical progression scale (CPS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19
CountriesGreece, Italy
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 23, 2020
Enrollment StartDec 23, 2020
Primary CompletionMar 31, 2021
Study CompletionFeb 6, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.5 years ago

Interventions

Anakinradrug

Standard-of-care and anakinra. Anakinra is injected subcutaneously as 100 mg once daily for 10 days

Placebodrug

Standard-of-care and placebo. Placebo is injected subcutaneously once daily for 10 days