TOFAcitinib in SARS-CoV2 Pneumonia

Università Politecnica delle Marche

Status and phase

Unknown

Phase 2

Conditions

SARS-COv2 Related Interstitial Pneumonia

Treatments

Drug: Tofacitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT04332042

TOFACoV

Details and patient eligibility

About

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.

Full description

Interstitial Pneumonia is the main complication of SARS-CoV2 infection. Immune system hyperactivation, leading to alveolar inflammation, is the main mechanism in determining lung damage. Evidence are accumulating about the pivotal role played by IL-6 in this disease. Preliminary evidence, indeed, point out the efficacy of an IL-6 receptor inhibitor in improving clinical conditions in a proportion of rapidly deteriorating patients. Our hypotesis is that a precocious inhibition of IL-6 signal, by the administration of tofacitinib (JAK 1/3 Inhibitor), could hinder the progression to more severe grades of lung inflammation leading to pulmonary function deterioration. In a prospective single cohort open study, 50 patients admitted in Hospital due to SARS-CoV 2 symptomatic interstitial pneumonia, but not requiring mechanical ventilation, will be enrolled. Tofacitinb will be administered every day for 14 days, starting within 24 h from the admission. The primary outcome is to evaluate the effect of this drug on the rate of patients who will need mechanical ventilation. Safety in this population will also be actively monitored.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)