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TOFAcitinib in SARS-CoV2 Pneumonia

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04332042
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Università Politecnica delle Marche
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	SARS-COv2 Related Interstitial Pneumonia

Additional Details

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.

Arms & Interventions

Arms

Experimental: tofacitinib

Tofacitinib cp 5mg: 2pills twice a day for 14 days

Interventions

Drug: - Tofacitinib

Tofacitinib 10mg twice a day will be administered within 24h from hospital admission for 14 days

Contact a Trial Team

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