Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection

NCT04361903 | Unknown

• 1 other identifier: 2020.COVID-19.RUXO106
• Study Type: observational
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Keywords

Ruxolitinib; Acute Respiratory Distress Syndrome; COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19

  Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours

  15 days

Secondary Outcomes (18)

• Improvement of respiratory performance - Arterial Blood Gas Analisys - pH

  15 days

• Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2

  15 days

• Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2

  15 days

• Improvement of respiratory performance - ratio values

  15 days

• Evaluation of known adverse events related to the use of the drug - D-Dimer

  15 days

Study Arms (1)

Patients treated with ruxolutinib

SARS-CoV-2 COVID-19 patients with rapid worsening of respiratory parameters in the last 12 hours treated with ruxolutinib, dosage of at least 20 mg x 2 / day in the first 48 hours.

Drug: Ruxolitinib Oral Tablet

Interventions

Ruxolitinib Oral Tablet DRUG

Ruxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours

Patients treated with ruxolutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label ruxolitinib treatment in the period between 03/24/2020 and 07/04/2020, with a dosage of at least 20 mg x 2 / day in the first 48 hours

You may qualify if:

• positive analysis for RT PCR (Shanghai BioTec or Sansure Biotech) for SARS-CoV-2 in a respiratory tract sample;
• Imaging (CT / ECO / RX) positive for pneumonia;
• Oxygen saturation (SaO2) of 93% or less in the environment;
• Partial oxygen pressure ratio (PaO2) on inspired oxygen fraction (FiO2) (PaO2 / FiO2) lower than 250 mg / Hg, but not lower than 100 mg / Hg;
• Rapid clinical evolution with worsening of respiratory parameters in the last 12 hours.
• Release of informed consent.

You may not qualify if:

• Pregnancy and breastfeeding;
• Patients already in assisted breathing with tracheal cannula;
• Patients with active and uncompensated serious pathologies previously to the COVID 19 infection;
• Known hypersensitivity to ruxolitinib or to any of the excipients listed in section 6.1 of the SPC;
• Patients with renal insufficiency;
• Patients with positive quantiferon;
• Patients with documented uncontrolled bacterial sepsis (excluding procalcitonin increase in the presence of negative blood cultures);
• Patients with neutropenia equal to or less than 1000 PMN / mmc;
• Patients with thrombocytopenia equal to or less than 100000 / mmc.
• HCV and / or HBV positive patients, HIV.

Sponsors & Collaborators

• Azienda USL Toscana Nord Ovest: lead
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator
• Azienda Ospedaliera Universitaria Senese: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator

Related Publications (1)

• Capochiani E, Frediani B, Iervasi G, Paolicchi A, Sani S, Roncucci P, Cuccaro A, Franchi F, Simonetti F, Carrara D, Bertaggia I, Nasso D, Riccioni R, Scolletta S, Valente S, Conticini E, Gozzetti A, Bocchia M. Ruxolitinib Rapidly Reduces Acute Respiratory Distress Syndrome in COVID-19 Disease. Analysis of Data Collection From RESPIRE Protocol. Front Med (Lausanne). 2020 Aug 4;7:466. doi: 10.3389/fmed.2020.00466. eCollection 2020.

  PMID: 32850921 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Enrico Dr Capochiani, hematologist

  Azienda USL Toscana Nord Ovest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Dr Capochiani, hematologist

CONTACT

00393473527340; enrico.capochiani@uslnordovest.toscana.it

Barbara Dr Meini, Pharmacist

CONTACT

00390586223031; barbara.meini@uslnordovest.toscana.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Hematologist

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 24, 2020
• Study Start: April 25, 2020
• Primary Completion: May 24, 2020
• Study Completion: May 31, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04