Covid19Phase 3AMMURAVIDNCT04832880
Factorial Randomized Trial of Rendesivir and Baricitinib Plus Dexamethasone for COVID-19 (the AMMURAVID Trial)
A Phase 3 study testing Baricitinib Oral Tablet [Olumiant], Remdesivir and Dexamethasone in people with Covid19, run by ASST Fatebenefratelli Sacco at 21 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Baricitinib Oral Tablet [Olumiant], Remdesivir and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 21 sitesItaly
- Study dates
- 6 Apr 2021to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged > 18 years able to provide a valid informed consent to the study
- Documented COVID-19 by direct testing (positive PCR), with lung infiltrates at imaging (Chest-X ray or CT) and requirement of oxygen supplementation
- Less than 10 days form symptoms onset
- Cytokine storm, using the criteria developed at Temple University (all of the three below criteria):
- CRP > 46 mg/l
- Ferritin > 250 ng/ml
Show all 24Show fewer
- One variable of each of the three clusters below
- Cluster 1
- Albumin < 2.8 g/dl
- Lymphocytes <10.2 % of WBC
- Absolute neutrophil count > 11400/mm3
- Cluster 2
- ALT > 60 U/L
- AST > 87 U/L
- D-dimers > 4930 µg/l fibrinogen-equivalent-units (FEU).
- LDH >416 U/L
- High sensitivity troponin > 1.09 ng/ml
- Cluster 3
- Anion Gap at arterial blood gas < 6.8 mM
- Chloride > 106 mM
- Potassium > 4.9 mM
- BUN:creatinine ratio > 29
- PaO2/FiO2 200-400 mmHg, while in oxygen therapy or continuous positive airway pressure (C-PAP)
- For women of childbearing potential and men: agreement to use contraception in the case of heterosexual intercourses before day 28 with a failure rate < 1% per year (bilateral tubal ligation, male sterilisation, hormonal contraceptives inhibiting ovulation, hormone-release or copper intrauterine devices). For men enrolled in the study, condom use is allowed.
Who cannot join
- Orotracheal intubation or ECMO support
- Active solid / hematologic cancer (including invasive non-melanoma skin cancer)
- Hypersensitivity or contra-indications to one of the investigational agents (including history of deep vein thrombosis / pulmonary thromboembolism within 12 weeks prior to screening)
- Other active concurrent viral, fungal or bacterial infections (including active tuberculosis/latent TB treated for less than 4 weeks, HIV and HCV/HBV infections)
- Pregnancy/breastfeeding
- Incapability to provide a valid informed consent (including age < 18 years old)
Show all 21Show fewer
- Heart failure with NYHA >= 2 or any acute cardiac or vascular event requiring therapy in the previous 12 months
- Chronic renal failure (baseline GFR < 45 ml/min*1.73m2)
- Liver cirrhosis moderate / severe (Child-Pugh B or C)
- Chronic respiratory failure requiring O2 therapy or ventilation therapy at home
- Blood neutrophils <1000/mcL, platelet <50000/mcL, Hb levels <80 g/l
- ALT/AST > 5 times UNL
- Use of any biologic agent or small molecule inhibitor and other investigational drugs in the previous 4 weeks or 5 half-lives (whichever is longer). Specific cut-offs for wash-out are required for the following therapies:
- B-cell targeted therapies: 24 weeks or 5 half-lives (whichever is longer)
- TNF-inhibitors: 2 weeks or 5 half-lives (whichever is longer)
- JAK-inhibitors: 1 week or 5 half-lives (whichever is longer)
- Use of other immunosuppressive agents in the last 3 months (chronic use of topical steroids and systemic steroids with a dose ≤5 mg of prednisone equivalents is allowed)
- Use of any other investigational therapy for COVID-19 (including IV immunoglobulins, convalescent COVID-19 plasma or monoclonal antibodies)
- Impossibility to discontinue Strong inhibitors of OAT3 (such as probenecid) at study entry
- Any other condition judged by the local investigator as a contra-indication to eligibility
- Subjects who have received live vaccines within 4 weeks before the study or are planned to receive live vaccine in the first months after study enrolment.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Italy21 sites
Ospedali Riuniti delle Marche
Ancona
Marcello Tavio, Prof
marcello.tavio@ospedaliriuniti.marche.it
Ospedale Parini
Aosta
Magnani Silvia Carla Maria, smagnani@ausl.vda.it
Ospedale SS Annunziata -Chieti
Chieti
Jacopo Vecchiet, Prof, jacopo.vecchiet@unich.it
Ospedale S Anna
Como
Luigi Pusterla, MD, luigi.pusterla@asst-lariana.it
Ospedale di Ferrara
Ferrara
Carlo Contini, Prof, cnc@unife.it
Ospedale di Firenze and Empoli
Florence
Massimo Di Pietro, MD, massimo.dipietro@uslcentro.toscana.it
Ospedali Galliera
Genova
Emanuele Pontali, MD, emanuele.pontali@galliera.it
H Goretti
Latina
Miriam Lichtner, Prof, miriam.lichtner@uniroma1.it
Ospedale Manzoni
Lecco
Stefania Piconi, MD, s.piconi@asst-lecco.it
Ospedale di Legnago
Legnago
Pierangelo Rovere, MD, pierangelo.rovere@aulss9.veneto.it
Ospedale di Legnano
Legnano
Stefano Rusconi, Prof, stefano.rusconi@unimi.it
ASST Fatebenefratelli-Sacco
Milan
Massimo Galli, Prof, massimo.galli@unimi.it
ASST Santi Paolo e Carlo
Milan
Antonella D'arminio monforte, Prof, antonella.darminio@unimi.it
IRCCS San Raffaele
Milan
Antonella Castagna, Prof, castagna.antonella@hsr.it
Ospedale di Perugia
Perugia
Andrea Tosti, MD, andrea.tosti@ospedale.perugia.it
Ospedale San Salvatore
Pesaro
Francesco, MD, francesco.barchiesi@ospedalimarchenord.it
Ospedali di Prato e Pistoia
Prato
Pierluigi Blanc, MD, pierluigi.blanc@uslcentro.toscana.it
Policlinico Tor Vergata
Roma
Massimo Andreoni, Prof, andreoni@uniroma2.it
Ospedale Cattinara e Maggiore
Trieste
Roberto Luzzati, roberto.luzzati@asugi.sanita.fvg.it
Ospedale di Udine
Udine
Carlo Tascini, Prof, carlo.tascini@asufc.sanita.fvg.it
Azienda Ospedaliera Integrata -Verona
Verona
Evelina Tacconelli, Prof, 3497790711 ext. +39, evelina.tacconelli@univr.it
About this study
Official title: Factorial, Multicentric, Randomized Clinical Trial of Remdesivir and Immunotherapy in Combination With Dexamethasone for Moderate COVID-19 (the AMMURAVID Trial)
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
- Being tested
- Baricitinib Oral Tablet [Olumiant], Remdesivir, Dexamethasone
- Keywords
- remdesivir, baricitinib, dexamethasone
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib Oral Tablet [Olumiant]Drug
Also called Olumiant
Baricitinib 4 mg die (2 mg for patients aged > 75 years) for 10 days.
RemdesivirDrug
Also called Veklury
Intravenous remdesivir 200 mg on day 1, followed by remdesivir 100 mg die until day 10
DexamethasoneDrug
Intravenous dexamethasone 6 mg for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Control arm (dexamethasone arm) | Experimental | IV dexamethasone 6 mg for 10 days Receives: Drug: Dexamethasone |
| Remdesivir arm | Experimental | IV dexamethasone 6 mg for 10 days + remdesivir IV 200 mg on day 1, followed by 100 mg die until day 10 Receives: Drug: Remdesivir; Drug: Dexamethasone |
| Baricitinib arm | Experimental | 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. Receives: Drug: Baricitinib Oral Tablet [Olumiant]; Drug: Dexamethasone |
| Remdesivir + baricitinib arm | Experimental | 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. Receives: Drug: Baricitinib Oral Tablet [Olumiant]; Drug: Remdesivir; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of very severe respiratory failure or mortality
Composite outcome: Development of very severe respiratory failure (PaO2/FiO2 <150 mmHg) or mortality
Measured: Day1-Day 28
Secondary outcomes (66)
Prevention of mortality
Proportion of dead patients
Measured: Day 7
Prevention of mortality
Proportion of dead patients
Measured: Day 14
Prevention of mortality
Proportion of dead patients
Measured: Day 21
Prevention of mortality
Proportion of dead patients
Measured: Day 28
Prevention of mortality
Survival analysis
Measured: Day 1-28
Prevention of very severe respiratory failure
Proportion of patients with PaO2/FiO2 <150 mmHg
Measured: Day 7
Prevention of very severe respiratory failure
Proportion of patients with PaO2/FiO2 <150 mmHg
Measured: Day 14
Prevention of very severe respiratory failure
Proportion of patients with PaO2/FiO2 <150 mmHg
Measured: Day 21
Prevention of very severe respiratory failure
Proportion of patients with PaO2/FiO2 <150 mmHg
Measured: Day 28
Prevention of very severe respiratory failure
Time to development very severe respiratory failure (PaO2/FiO2 <150 mmHg)
Measured: Day 1-28
Prevention of very severe respiratory failure or mortality
Composite outcome: Development of very severe respiratory failure (PaO2/FiO2 <150 mmHg) or mortality
Measured: Day 7
Prevention of very severe respiratory failure or mortality
Composite outcome: Development of very severe respiratory failure (PaO2/FiO2 <150 mmHg) or mortality
Measured: Day 14
Prevention of very severe respiratory failure or mortality
Composite outcome: Development of very severe respiratory failure (PaO2/FiO2 <150 mmHg) or mortality
Measured: Day 21
Incidence of Adeverse Events
Proportion of number of AEs and SAEs (according to the Common Terminology Criteria for Adverse Events -CTCAE, Version 5.0)
Measured: Day 7
Incidence of Adeverse Events
Proportion of number of AEs and SAEs (according to the Common Terminology Criteria for Adverse Events -CTCAE, Version 5.0)
Measured: Day 14
Incidence of Adeverse Events
Proportion of number of AEs and SAEs (according to the Common Terminology Criteria for Adverse Events -CTCAE, Version 5.0)
Measured: Day 21
Incidence of Adeverse Events
Proportion of number of AEs and SAEs (according to the Common Terminology Criteria for Adverse Events -CTCAE, Version 5.0)
Measured: Day 28
Incidence of bacterial/fungal infections
Rate of bacterial/fungal infections
Measured: Day 7
Incidence of bacterial/fungal infections
Rate of bacterial/fungal infections
Measured: Day 14
Incidence of bacterial/fungal infections
Rate of bacterial/fungal infections
Measured: Day 21
Incidence of bacterial/fungal infections
Rate of bacterial/fungal infections
Measured: Day 28
Reduction of the requirements of orotracheal intubation/ECMO
Proportion of patients requiring orotracheal intubation/ECMO
Measured: Day 7
Reduction of the requirements of orotracheal intubation/ECMO
Proportion of patients requiring orotracheal intubation/ECMO
Measured: Day 14
Reduction of the requirements of orotracheal intubation/ECMO
Proportion of patients requiring orotracheal intubation/ECMO
Measured: Day 21
Reduction of the requirements of orotracheal intubation/ECMO
Proportion of patients requiring orotracheal intubation/ECMO
Measured: Day 28
Reduction of the requirements of orotracheal intubation/ECMO
Days with orotracheal intubation/ECMO
Measured: Day 1-28
Evolution of the NEWS-2 score
Course in the National Early Warning Score-2 score (0-20, with higher scores worse)
Measured: Day 1-28
Evolution of the MELD score
Course in the Model for End-Stage Liver Disease score (scores >=6, higher scores worse)
Measured: Day 1-28
Velocity in clinical improvement
Time to clinical improvement (defined as one of the following: a) discharge, b) absent ventilator support with NEWS-2 score ≤3 and MELD ≤13)
Measured: Day 1-28
Velocity in discharge
Time to discharge
Measured: Day 1-28
Velocity in discharge
Proportion of discherged patients
Measured: Day 7
Velocity in discharge
Proportion of discherged patients
Measured: Day 14
Velocity in discharge
Proportion of discherged patients
Measured: Day 21
Velocity in discharge
Proportion of discherged patients
Measured: Day 28
Fever disappearance
Proportion of patients on persistent defervescence (last day of T<37.0°C, without recurrent T>37.0° for at least 4 days)
Measured: Day 7
Fever disappearance
Proportion of patients on persistent defervescence (last day of T<37.0°C, without recurrent T>37.0° for at least 4 days)
Measured: Day 14
Fever disappearance
Proportion of patients on persistent defervescence (last day of T<37.0°C, without recurrent T>37.0° for at least 4 days)
Measured: Day 21
Fever disappearance
Proportion of patients on persistent defervescence (last day of T<37.0°C, without recurrent T>37.0° for at least 4 days)
Measured: Day 28
Fever disappearance
Time to persistent defervescence persistent defervescence (last day of T<37.0°C, without recurrent T>37.0° for at least 4 days)
Measured: Day 1-28
Changes in periperal blood leukocyte number
Course of periperal blood leukocyte number
Measured: Day 1-28
Changes in periperal blood neutrophils counts
Comparison of the course of neutrophils counts at full blood counts among the treatment arm, as assessed by repeated measures analysis.
Measured: Day 1-28
Changes in periperal blood lymphocytes
Comparison of the course of lymphocytes counts at full blood counts among the treatment arm, as assessed by repeated measures analysis.
Measured: Day 1-28
Changes in periperal blood platelets
Comparison of the course of plateletscounts at full blood counts among the treatment arm, as assessed by repeated measures analysis.
Measured: Day 1-28
Changes in blood hemoglobin levels
Course of blood hemoglobin
Measured: Day 1-28
Changes in blood creatinine levels
Course of blood creatine levels
Measured: Day 1-28
Changes in blood albumin
Course of blood albumin levels
Measured: Day 1-28
Changes in blood bilirubin
Course of blood bilirubin levles
Measured: Day 1-28
Changes in blood LDH
Course of blood LDH levels
Measured: Day 1-28
Changes in blood AST
Course of blood AST levels
Measured: Day 1-28
Changes in blood ALT
Course of blood ALT levels
Measured: Day 1-28
Changes in blood CK
Course of blood CK levels
Measured: Day 1-28
Changes in blood C-reactive protein
Course of blood C-reactive protein levels
Measured: Day 1-28
Changes in blood IL-6
Course of blood IL-6 levels
Measured: Day 1-28
Changes in blood protrombine time (INR)
Course of blood protrombine time (INR)
Measured: Day 1-28
Changes in blood ferritin
Course of blood ferritin levels
Measured: Day 1-28
Changes in blood troponin T
Course of blood troponin T levels
Measured: Day 1-28
Changes in blood triglycerides
Course of blood triglycerides levels
Measured: Day 1-28
Changes in blood HDL-colesterol
Course of blood HDL-colesterol levels
Measured: Day 1-28
Changes in blood total colesterol
Course of blood total colesterol levels
Measured: Day 1-28
Changes in blood D-Dimer
Course of blood D-Dimer levels
Measured: Day 1-28
Changes in PaO2 at arterial gas analysis
Course of PaO2 at arterial gas analysis and PaO2/FiO2
Measured: Day 1-28
Changes in PaO2/FiO2
Course of PaO2/FiO2
Measured: Day 1-28
Development of late complications
Death
Measured: 6 months
Development of late complications
New Hospital admissions
Measured: 6 months
Development of late complications
Proportion of patients developing new medical conditions in each interventional arm as compared to the control arm. Specific focus to:
- new-onset interstitial lung disease
- new onset respiratory failure requiring O2 therapy or ventilation therapy at home
- thromboembolic event
- ischemic events (stroke, acute coronary syndromes, pe-ripheral ischemias)
- arterial hypertension
Measured: 6 months
Development of late complications
Proportion of patients with FVC < 70% of predicted, FEV1 < 70% predicted and DLCO < 80% predicted
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start6 Apr 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Factorial design with four-stages (K=4). Three interim analyses are pre-planned. At each stage, the use of remdesivir and/or baricitinib might be suspended due to futility or ef-ficacy. Overall, we will accept a two-sided alpha error of alpha=0.05 and a beta error of β=0.10.
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Tombetti, ASST Fatebenefratelli Sacco
- Investigators
- Massimo Galli, MD, PhD, Principal investigator, ASST Fatebenefratelli Sacco and Milan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832880
- Sponsor's protocol ID
- The AMMURAVID trial
- Other IDs
- 2020-001854-23
- Acronym
- AMMURAVID
- Status last verified
- Apr 2021
- First submitted
- 12 Oct 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The e-CRF platform (Cloud-R) ensures data protection and satisties all quality requirements for data management and protection of patients confidentiality. Confidential data will be available only for physicians in charge of individual patients. Anonymized data will be made available to other research upon written request accompanied with a motivation and a scientific rationale
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factorial, Multicentric, Randomized Clinical Trial of Remdesivir and Immunotherapy in Combination With Dexamethasone for Moderate COVID-19 (the AMMURAVID Trial)
- ClinicalTrials.gov ID
- NCT04832880
- Acronym / sponsor ID
- AMMURAVID / The AMMURAVID trial
- Conditions
- Covid19
- Keywords
- remdesivir, baricitinib, dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Study start
- 6 Apr 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Factorial design with four-stages (K=4). Three interim analyses are pre-planned. At each stage, the use of remdesivir and/or baricitinib might be suspended due to futility or ef-ficacy. Overall, we will accept a two-sided alpha error of alpha=0.05 and a beta error of β=0.10.
| Arm | Type | Receives |
|---|---|---|
| Control arm (dexamethasone arm) | Experimental | Drug: DexamethasoneIV dexamethasone 6 mg for 10 days |
| Remdesivir arm | Experimental | Drug: Remdesivir, Drug: DexamethasoneIV dexamethasone 6 mg for 10 days + remdesivir IV 200 mg on day 1, followed by 100 mg die until day 10 |
| Baricitinib arm | Experimental | Drug: Baricitinib Oral Tablet [Olumiant], Drug: DexamethasoneIV 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. |
| Remdesivir + baricitinib arm | Experimental | Drug: Baricitinib Oral Tablet [Olumiant], Drug: Remdesivir, Drug: DexamethasoneIV 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Adults aged > 18 years able to provide a valid informed consent to the study
- Documented COVID-19 by direct testing (positive PCR), with lung infiltrates at imaging (Chest-X ray or CT) and requirement of oxygen supplementation
- Less than 10 days form symptoms onset
- Cytokine storm, using the criteria developed at Temple University (all of the three below criteria):
- PaO2/FiO2 200-400 mmHg, while in oxygen therapy or continuous positive airway pressure (C-PAP)
Key exclusion criteria (21 listed)
- Orotracheal intubation or ECMO support
- Active solid / hematologic cancer (including invasive non-melanoma skin cancer)
- Hypersensitivity or contra-indications to one of the investigational agents (including history of deep vein thrombosis / pulmonary thromboembolism within 12 weeks prior to screening)
- Other active concurrent viral, fungal or bacterial infections (including active tuberculosis/latent TB treated for less than 4 weeks, HIV and HCV/HBV infections)
- Pregnancy/breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baricitinib Oral Tablet [Olumiant]Also: OlumiantBaricitinib 4 mg die (2 mg for patients aged > 75 years) for 10 days. | Drug | Baricitinib arm, Remdesivir + baricitinib arm |
| RemdesivirAlso: VekluryIntravenous remdesivir 200 mg on day 1, followed by remdesivir 100 mg die until day 10 | Drug | Remdesivir + baricitinib arm, Remdesivir arm |
| DexamethasoneIntravenous dexamethasone 6 mg for 10 days | Drug | Baricitinib arm, Control arm (dexamethasone arm), Remdesivir + baricitinib arm, Remdesivir arm |
Primary outcome
Prevention of very severe respiratory failure or mortality
Time frame: Day1-Day 28
Composite outcome: Development of very severe respiratory failure (PaO2/FiO2 <150 mmHg) or mortality
66 secondary outcomes
Prevention of mortality
Time frame: Day 7
Prevention of mortality
Time frame: Day 14
Prevention of mortality
Time frame: Day 21
Prevention of mortality
Time frame: Day 28
Prevention of mortality
Time frame: Day 1-28
Prevention of very severe respiratory failure
Time frame: Day 7
Prevention of very severe respiratory failure
Time frame: Day 14
Prevention of very severe respiratory failure
Time frame: Day 21
Prevention of very severe respiratory failure
Time frame: Day 28
Prevention of very severe respiratory failure
Time frame: Day 1-28
Prevention of very severe respiratory failure or mortality
Time frame: Day 7
Prevention of very severe respiratory failure or mortality
Time frame: Day 14
Prevention of very severe respiratory failure or mortality
Time frame: Day 21
Incidence of Adeverse Events
Time frame: Day 7
Incidence of Adeverse Events
Time frame: Day 14
Incidence of Adeverse Events
Time frame: Day 21
Incidence of Adeverse Events
Time frame: Day 28
Incidence of bacterial/fungal infections
Time frame: Day 7
Incidence of bacterial/fungal infections
Time frame: Day 14
Incidence of bacterial/fungal infections
Time frame: Day 21
Incidence of bacterial/fungal infections
Time frame: Day 28
Reduction of the requirements of orotracheal intubation/ECMO
Time frame: Day 7
Reduction of the requirements of orotracheal intubation/ECMO
Time frame: Day 14
Reduction of the requirements of orotracheal intubation/ECMO
Time frame: Day 21
Reduction of the requirements of orotracheal intubation/ECMO
Time frame: Day 28
Reduction of the requirements of orotracheal intubation/ECMO
Time frame: Day 1-28
Evolution of the NEWS-2 score
Time frame: Day 1-28
Evolution of the MELD score
Time frame: Day 1-28
Velocity in clinical improvement
Time frame: Day 1-28
Velocity in discharge
Time frame: Day 1-28
Velocity in discharge
Time frame: Day 7
Velocity in discharge
Time frame: Day 14
Velocity in discharge
Time frame: Day 21
Velocity in discharge
Time frame: Day 28
Fever disappearance
Time frame: Day 7
Fever disappearance
Time frame: Day 14
Fever disappearance
Time frame: Day 21
Fever disappearance
Time frame: Day 28
Fever disappearance
Time frame: Day 1-28
Changes in periperal blood leukocyte number
Time frame: Day 1-28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No. The e-CRF platform (Cloud-R) ensures data protection and satisties all quality requirements for data management and protection of patients confidentiality. Confidential data will be available only for physicians in charge of individual patients. Anonymized data will be made available to other research upon written request accompanied with a motivation and a scientific rationale
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Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Galli, MD, PhD principal investigator
ASST Fatebenefratelli Sacco and Milan University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baricitinib Oral Tablet [Olumiant], Remdesivir and Dexamethasone in people with Covid19, run by ASST Fatebenefratelli Sacco at 21 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrico Tombetti, MD, PhD (3289098793 ext. +39, enrico.tombetti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of very severe respiratory failure or mortality (time frame: Day1-Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.