Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT04390061
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04390061
Study Brief:
Protocol Section:
NCT04390061