TOFAcitinib in SARS-CoV2 Pneumonia

• Status: Not yet recruiting
• Trial end date: 2020-07-10
• Target enrollment: 0
• Participant gender: All

Summary

Immune-mediated lung injury plays a pivotal role in severe interstitial pnemumonia related to SARS-CoV2 infection. Tofacitinib, a JAK1/3-Inhibitor, could mitigate alveolar inflammation by blocking IL-6 signal. The aim of this prospective single cohort open study is to test the hypotesis that early administration of tofacitinib in patients with symptomatic pneumonia could reduce pulmonary flogosis, preventing function deterioration and the need of mechanical ventilation and/or admission in intensive care units.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Università Politecnica delle Marche
• Treatments: Tofacitinib

Criteria

Inclusion Criteria:

• SARS-CoV2 Infection diagnosed by rt-PCR

• Rx or CT-scan confirmed interstitial pneumonia

• Hospital admission from less than 24h

• Written Informed Consent

Exclusion Criteria:

• Age <18 ys or >65

• Patients in mechanical ventilation at time of admission

• Severe Hearth failure (NYHA 3 or 4)

• Severe History of Chronic Ischemic Hearth Disease, defined as history of Major Adverse Cardiovascular Event and/or recent (one year) revascularization.

• History of recurrent Deep Venous Thrombosis and Pulmonary Embolism

• Active Bacterial or Fungal Infection

• Hematological cancer

• Metastatic or intractable cancer

• Pre-existent neurodegenerative disease

• Severe Hepatic Impairment

• Severe Renal Failure (Creatinine Clearance <30ml/h)

• Active Herpes zoster infection

• Severe anemia (Hb<9g/dl)

• Lymphocyte count below 750/mcl

• Neutrophil count below 1000/mcl

• Platelet count below 50000/mcl

• Pregnancy or Lactation

• Inability to give informed consent (severe transitory or permanent mental impairment, incapacitation)