TOFAcitinib in SARS-CoV2 Pneumonia
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ClinicalTrials.gov Identifier: NCT04332042 |
Recruitment Status : Unknown
Verified April 2020 by Armando Gabrielli, Università Politecnica delle Marche.
Recruitment status was: Not yet recruiting
First Posted : April 2, 2020
Last Update Posted : April 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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SARS-COv2 Related Interstitial Pneumonia | Drug: Tofacitinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | prospective cohort study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | TOFAcitinib in Patients With Early Onset SARS-CoV2 Interstitial Pneumonia |
Estimated Study Start Date : | April 10, 2020 |
Estimated Primary Completion Date : | June 20, 2020 |
Estimated Study Completion Date : | July 10, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: tofacitinib
Tofacitinib cp 5mg: 2pills twice a day for 14 days
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Drug: Tofacitinib
Tofacitinib 10mg twice a day will be administered within 24h from hospital admission for 14 days |
- need of mechanical ventilation [ Time Frame: day 14 ]Rate of patients needing mechanical ventilation to maintain PaO2/FIO2>150 or, if PaO2 data not available, to maintain SO2>94% with FiO2 0,5.
- need of admission in intensive care unit [ Time Frame: day 14 ]Rate of patients needing admission to the intensive care unit for oro-tracheal intubation and/or evidence of Multiple Organ Disfunction
- death [ Time Frame: day 28 ]rate of patients dead
- rate of adverse events [ Time Frame: day 28 ]rate and type of adverse events

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332042
Italy | |
Ospedali Riuniti di Ancona | |
Ancona, Marche, Italy, 60126 | |
Contact: Armando Gabrielli, Prof +390712206104 a.gabrielli@staff.univpm.it | |
Principal Investigator: Armando Gabrielli, Prof | |
Sub-Investigator: Giovanni Pomponio, Dr |
Responsible Party: | Armando Gabrielli, Full Professor Internal Medicine, Università Politecnica delle Marche |
ClinicalTrials.gov Identifier: | NCT04332042 |
Other Study ID Numbers: |
TOFACoV |
First Posted: | April 2, 2020 Key Record Dates |
Last Update Posted: | April 2, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tofacitinib Pneumonia COVID-19 Lung Diseases, Interstitial Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Pneumonia, Viral |
Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |