TOFAcitinib in Patients With Early Onset SARS-CoV2 Interstitial Pneumonia
Latest Information Update: 10 Apr 2022
At a glance
- Drugs Tofacitinib (Primary)
- Indications COVID 2019 infections
- Focus Therapeutic Use
- 09 Apr 2020 According to a Pfizer media release, this study is planned to be initiated later this week and is supported by a Pfizer grant.
- 06 Apr 2020 New trial record
Most Recent Events
Trial Overview
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.
Primary Endpoints
need of mechanical ventilation
description: 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.
time_frame: day 14
Other Endpoints
need of admission in intensive care unit
description: Rate of patients needing admission to the intensive care unit for oro-tracheal intubation and/or evidence of Multiple Organ Disfunction
time_frame: day 14
death
description: rate of patients dead
time_frame: day 28
rate of adverse events
description: rate and type of adverse events
time_frame: day 28 [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | treatment | - |
Subjects
- Subject Type patients
-
Number
Planned: 50
- Sex male & female
- Age Group 18-65 years; adult
Patient 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
Patient 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
Identifiers
| Identifier | Owner |
|---|---|
| NCT04332042 | ClinicalTrials.gov: US National Institutes of Health |
| TOFACoV | - |
Organisations
- Affiliations Pfizer
Trial Dates
-
Initiation Dates
Planned : 10 Apr 2020
Actual : 10 Apr 2020
-
Primary Completion Dates
Planned : 20 Jun 2020
-
End Dates
Planned : 10 Jul 2020
Other Details
- Design cohort; open; prospective
- Phase of Trial Phase II
- Location Italy
- Focus Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| TofacitinibPrimary Drug | Oral | Pill |
tofacitinib
Tofacitinib cp 5mg: 2pills twice a day for 14 days
Drug: Tofacitinib (Tofacitinib 10mg twice a day will be administered within 24h from hospital admission for 14 days)
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
|
Armando Gabrielli, Prof
+390712206104
show details
a.gabrielli@staff.univpm.it |
Ospedali Riuniti di Ancona | Italy |
| Giovanni Pomponio, Dr | Ospedali Riuniti di Ancona | Italy |
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| Ospedali Riuniti di Ancona | Ancona, Marche | Italy |
| Università Politecnica delle Marche |
-
|
-
|
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 10 Apr 2022 | Other trial event | Last checked against ClinicalTrials.gov: US National Institutes of Health record. Updated 10 Apr 2022 |
| 10 Apr 2022 | Other trial event | According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified April 2020). Updated 10 Apr 2022 |
| 09 Apr 2020 | Other trial event | According to a Pfizer media release, this study is planned to be initiated later this week and is supported by a Pfizer grant. Updated 13 Apr 2020 |
| 06 Apr 2020 | New trial record | New trial record Updated 06 Apr 2020 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Pfizer. Pfizer Advances Battle Against COVID-19 on Multiple Fronts. Media-Rel 2020;.
Media Release
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