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:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT04610567
Eligibility Criteria:
Inclusion Criteria:
* Patients who were hospitalized with confirmed COVID-19
* Mild Coronavirus-19 disease (WHO Coronavirus-19 scale \< 5)
* Fewer than 14 days since symptom onset.
* Female patient is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile.
* Female patient is of childbearing potential must has a negative pregnancy test.
* Signing the study informed consent.
Exclusion Criteria:
* Need for oxygen supplementation \>4 L/min via nasal cannula or ≥40% via Venturi mask.
* Need for oxygen supplementation via high-flow nasal cannula.
* Need for invasive mechanical ventilation.
* Extent of pulmonary involvement \> 50% by CT scan.
* Chronic renal failure (estimated glomerular filtration rate \<30 mL/min/1.73 m2)
* History of liver cirrhosis (Bilirubins levels \> 3mg/dl)
* History of heart failure ( Ejection fraction \<40%)
* History of Steven-Johnson disease
* History of stroke in the last 6 months
* History of sickle cell disease
* Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers.
* Prior history of chronic hepatitis B or C infection and known HIV positive.
* Patient undergoing chemotherapy for cancer
* Sepsis caused by fungal or multidrug resistant gram-negative bacteria
* Known allergy to methotrexate.
* Body mass index(BMI) \> 40 or \<18.5
* Pregnancy or breastfeeding.
* Patients enrolled in other clinical trials in the last 12 months
* Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04610567
Study Brief:
Protocol Section:
NCT04610567