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Factorial Randomized Trial of Rendesivir and Baricitinib Plus Dexamethasone for COVID-19 (the AMMURAVID Trial)

NCT04832880 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2021-04-06

No results posted yet for this study

Summary

Background:

In the current worldwide medical emergency, a rapid identification of effective therapeutic strategy is crucial. So far, therapy with dexamethasone, remdesivir and baricitinib have been associated with evidence of impact on the clinical impact on COVID-19, but the effect of baricitinib and remdesivir in combination with dexamethasone.

The AAMMURAVID trial is endorced and supported by the Italian Regulatory agency (AIFA-Agenzia Italiana del Farmaco)

Conditions

  • Covid19

Interventions

DRUG

Baricitinib Oral Tablet [Olumiant]

Baricitinib 4 mg die (2 mg for patients aged \> 75 years) for 10 days.

DRUG

Remdesivir

Intravenous remdesivir 200 mg on day 1, followed by remdesivir 100 mg die until day 10

DRUG

Dexamethasone

Intravenous dexamethasone 6 mg for 10 days

Sponsors & Collaborators

  • ASST Fatebenefratelli Sacco

    lead OTHER

Principal Investigators

  • Massimo Galli, MD, PhD · ASST Fatebenefratelli Sacco and Milan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2022-03-31
Completion
2022-12-31

Countries

  • 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 NCT04832880 on ClinicalTrials.gov