TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With COVID-19 Interstitial Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-10-31

Brief Summary

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Multifocal interstitial pneumonia represents the most common cause of admission in intensive care units and death in SARS-CoV2 infections. In our Hospital, similarly to what reported in literature, up to 25% of admitted patients with pneumonitis requires mechanical ventilation or oro-tracheal intubation within 5-10 days. No established treatment is available for this condition. Preliminary evidence is accumulating about the efficacy of an aggressive treatment of the corona virus-induced inflammation and, in particular, investigators believe that blocking JAK1 is clinically rewarding in down-regulating IL-6 driven inflammation in patients with corona-virus infection. Thus, investigators designed a randomized controlled trial to test the hypothesis that adding Tofacitinib to the standard treatment in the early phase of COVID related pneumonitis could prevent the development of severe respiratory failure needing mechanical ventilation.

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Detailed Description

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Conditions

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Pneumonitis, Interstitial COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter open label randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tofacitinib+HYQ

Tofacitinib 10mg cp twice a day + Hydroxychloroquine 200mg cp three times a day, both for 14 days

Group Type EXPERIMENTAL

Tofacitinib

Intervention Type DRUG

Jak-1/3 inhibitor

Hydroxychloroquine

Intervention Type DRUG

Standard Therapy

Hydroxychloroquine

Hydroxychloroquine 200mg cp three times a day for 14 days

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type DRUG

Standard Therapy

Interventions

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Tofacitinib

Jak-1/3 inhibitor

Intervention Type DRUG

Hydroxychloroquine

Standard Therapy

Intervention Type DRUG

Other Intervention Names

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Xeljanz

Eligibility Criteria

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Inclusion Criteria

* SARS-CoV2 Infection diagnosed by rt-PCR
* CT-scan confirmed interstitial pneumonia
* Hospital admission from less than 24h
* P/F ratio \>150 mmHg
* 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)
* QTc \> 470 ms or \>500 ms in wide QRS patients
* Severe History of Chronic Ischemic Heart Disease, defined as history of Major Adverse Cardiovascular Event and/or recent (one year) revascularization.
* History of recurrent Deep Venous Thrombosis and Pulmonary Embolism or established thrombophilic conditions (e.g. history of anti-phospholipid antibodies, …)
* Active Bacterial or Fungal Infection
* Hematological cancer
* Metastatic or intractable cancer
* Pre-existent neurodegenerative disease
* Severe Hepatic Impairment,
* History of acute diverticular disease or intestinal perforation
* HBsAg positive and/or HBV-DNA positive patients
* Severe Renal Failure (Creatinine Clearance \<30ml/h)
* Active Herpes zoster infection
* Patients with active or latent TB
* Severe anemia (Hb\<9g/dl)
* Lymphocyte count below 750/mcl
* Neutrophil count below 1000/mcl
* Platelet count below 50000/mcl
* Pregnancy or Lactation
* History of intolerance to the experimental drugs or excipients
* Degenerative maculopathy or other relevant retinal disease
* Inability to give informed consent (severe transitory or permanent mental impairment, incapacitation)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No