Covid19 Clinical Trial
— Nano-COVID19Official title:
Two Phases Clinical Trial to Evaluate Safety and Efficacy of Methotrexate Associated to LDL Like Nanoparticles (LDE-MTX) in the Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease.
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 15, 2021 |
Est. primary completion date | March 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Heart Institute (InCor) - University of São Paulo Medical School, São Paulo, Brazil | São Paulo | SP |
Brazil | Hospital Santa Marcelina | São Paulo | SP |
Brazil | Institute Prevent Senior | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Hospital Santa Marcelina |
Brazil,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of hospital stay | Compare the duration of hospital stay between groups | 30 days after randomization | |
Secondary | Number of participants requiring mechanical ventilation | The secondary outcome is the need for mechanical ventilation between groups | 15 days after randomization | |
Secondary | Number of participants requiring vasoactive drugs | The secondary outcome is the need for vasoactive drugs between groups | 15 days after randomization | |
Secondary | Number of participants requiring renal replacement therapy | The secondary outcome is the need for renal replacement therapy between groups | 15 days after randomization | |
Secondary | Incidence of secondary infection | The secondary outcome is the incidence of secondary infection between groups | 15 days after randomization | |
Secondary | Sequential Organ Failure Assessment (SOFA) score | The secondary outcome is the comparison of Sequential Organ Failure Assessment (SOFA) score between groups | Baseline and change from baseline to 15 days after randomization | |
Secondary | World Health Organization (WHO) COVID-19 score | The secondary outcome is the comparison of World Health Organization (WHO) COVID-19 clinical score between groups | Baseline and change from baseline to 15 days after randomization | |
Secondary | Interleukin 6 (IL-6) | The secondary outcome is the comparison of IL-6 levels between groups | Baseline and change from baseline to 15 days after randomization | |
Secondary | Dimer-D | The secondary outcome is the comparison of dimer-D levels between groups | Baseline and change from baseline to 15 days after randomization | |
Secondary | Chest CT scan | The secondary outcome is the comparison of chest CT scan between groups | Baseline and change from baseline to 15 days after randomization | |
Secondary | Incidence and severity of laboratory alterations | The secondary outcome is the comparison of red blood cells; white blood cells;Platelets; Urea;Creatinine levels between groups | 30 days after randomization | |
Secondary | Clinical side effects | Compare the incidence of clinical significant symptoms (new and persistent stomatitis, vomiting, diarrhea, alopecia, neurotoxicity, bradycardia, hypotension, local pain) reported between groups. | 30 days after randomization | |
Secondary | Other adverse events | Compare the incidence of other adverse events (not expected) between groups | 30 days after randomization |
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