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suPAR-Guided Anakinra Treatment for Management of Severe Respiratory Failure by COVID-19

NCT04680949 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 606

Last updated 2022-09-06

No results posted yet for this study

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).

Conditions

  • Covid19

Interventions

DRUG

Anakinra

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Hellenic Institute for the Study of Sepsis

    lead OTHER

Principal Investigators

  • Evangelos Giamarellos-Bourboulis, MD, PhD · Hellenic Institute for the Study of Sepsis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2021-03-31
Completion
2022-02-06

Countries

  • Greece
  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT04680949 on ClinicalTrials.gov