Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19)

• Status: Recruiting
• Trial end date: 2021-07-15
• Target enrollment: 0
• Participant gender: All

Summary

The investigators propose a prospective, randomized, double-blind, placebo-controlled study, conducted in two phases. The purpose of the study is to evaluate the safety and efficacy of methotrexate in a cholesterol-rich non-protein nanoparticle (MTX -LDE) in adults diagnosed with mild Coronavirus-19(COVID-19) disease.

A total of 100 patients will be randomized to receive MTX-LDE or placebo each 7 days, up to 3 times, during in hospital treatment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Collaborator: Hospital Santa Marcelina
• Treatments: Methotrexate

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.