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Trial - NCT04610567


Column Value
Trial registration number NCT04610567
Full text link
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04610567

First author
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Raul Maranhão, MD;PhD

Contact
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

raul.maranhao@incor.usp.br

Registration date
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-10-30

Recruitment status
Last imported at : Jan. 6, 2023, 8 p.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

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
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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.

Number of arms
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

University of Sao Paulo General Hospital

Inclusion age min
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 16, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Brazil

Type of patients
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

primary outcome
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Duration of hospital stay

Notes
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1/Phase 2

Arms
Last imported at : Oct. 31, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "15mg or 30 mg", "treatment_id": 796, "treatment_name": "Methotrexate-lde", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "30mg", "treatment_id": 796, "treatment_name": "Methotrexate-lde", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]