NCT04832880

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

Factorial, Multicentric, Randomized Clinical Trial of Remdesivir and Immunotherapy in Combination With Dexamethasone for Moderate COVID-19 (the AMMURAVID Trial)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,000 (estimated)
• Sponsor: ASST Fatebenefratelli Sacco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-04-06
• Primary completion: 2022-03-01
• Completion: 2022-12-01
• First posted: 2021-04-06
• Last updated: 2021-04-06

Locations

21 sites across 1 country: Italy