Status:
UNKNOWN
TOFAcitinib Plus Hydroxycloroquine vs Hydroxycloroquine in Patients With COVID-19 Interstitial Pneumonia
Lead Sponsor:
Università Politecnica delle Marche
Collaborating Sponsors:
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Ospedale Civile Santo Spirito, Pescara
Conditions:
Pneumonitis, Interstitial
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04390061
Start Date
June 1 2020
End Date
October 1 2020
Last Update
May 15 2020
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