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

Sponsor
ASST Fatebenefratelli Sacco
Study ID
NCT04832880
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib Oral Tablet [Olumiant] — DRUG
    Baricitinib 4 mg die (2 mg for patients aged \> 75 years) for 10 days.
  • Remdesivir — DRUG
    Intravenous remdesivir 200 mg on day 1, followed by remdesivir 100 mg die until day 10
  • Dexamethasone — DRUG
    Intravenous dexamethasone 6 mg for 10 days

Study Details

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)

Key Dates

Start date
Apr 6, 2021
Status verified
Apr 2021
Primary completion
Mar 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
4,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Control arm (dexamethasone arm)
    IV dexamethasone 6 mg for 10 days
  • Experimental: Remdesivir arm
    IV dexamethasone 6 mg for 10 days + remdesivir IV 200 mg on day 1, followed by 100 mg die until day 10
  • Experimental: Baricitinib arm
    IV dexamethasone 6 mg for 10 days + baricitinib 4 mg die for 10 days. For patients aged \> 75 years or estimated GFR \< 60 ml/min\*1.73m2, baricitinib dose is reduced to 2 mg for 10 days.
  • Experimental: Remdesivir + baricitinib arm
    IV dexamethasone 6 mg for 10 days + remdesivir IV 200 mg on day 1, followed by 100 mg die until day 10 + baricitinib 4 mg die for 10 days. For patients aged \> 75 years or estimated GFR \< 60 ml/min\*1.73m2, baricitinib dose is reduced to 2 mg for 10 days.

Primary Outcome Measure

Prevention of very severe respiratory failure or mortality [ Time Frame: Day1-Day 28 ]

Central Contacts

Related Studies