COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04727424

Gilmar Reis, MD, PhD

administrador@cardresearch.org

2021-01-27

Recruiting

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

a - inclusion criteria (except fluoxetine + budesonide and paracetamol arms): patients over 18 years old with the ability to provide free and informed consent acute flu-like symptoms < 07 days. patients with at least one enhancement criteria: age > 50 years. diabetes mellitus requiring oral medication or insulin. systemic arterial hypertension requiring at least 01 oral medication for bp control. known cardiovascular diseases (heart failure, congenital heart disease, valvar heart valve disease, coronary artery disease, cardiomyopathies). symptomatic lung disease (emphysema, chronic bronchitis). symptomatic asthma patients requiring chronic use of agents for control of symptoms. fever > 38 c at baseline. obesity, defined as bmi> 30 kg / m2 body weight. transplanted patients. patient with stage iv chronic kidney disease or on dialysis. immunosuppressed patients/ using corticosteroid therapy (equivalent to maximum 10 mg of prednisone per day) and/ or immunosuppressive therapy). patients with a history of cancer in the last 05 years or undergoing treatment of a current cancer. chronic renal disease kdigo iv or end-stage renal disease on chronic ambulatory renal replacement therapy. patients with important limitation of daily activities due to: dyspnea, chest pain myalgia (limited to 25% of all randomizations). patient with positive rapid test for sars-cov2 antigen performed on occasion of the screening or patient with a positive sars-cov2 diagnostic test within 07 days of the onset of symptoms. willingness to use the proposed investigative treatment and follow the protocol-related procedures foreseen in the research. specific inclusion criteria for the fluvoxamine arm: present significant dyspnea, arterial hypotension, severe dehydration or spo2 between 85 to 93% in room air at admission and medical decision to discharge patient home, with an observation period at er not exceeding 12 hours. b - inclusion criteria for the fluoxetine + budesonide combination arm (07 days of treatment - partnership with the "anticov consortium"): patients over 18 years of age with the ability to provide free and informed consent. patients treated at a basic health unit of the unified health system (sus) or patients treated at emergency care units of the sus or supplementary medicine with an acute clinical condition compatible with covid 19. patients over 18 years of age and a history of at least one of the following criteria. diabetes mellitus, heart disease, chronic kidney disease, chronic obstructive pulmonary disease, cerebrovascular diseases or patients considered to be underweight or overweight according to the investigator's judgment (bmi ≤ 16 or bmi > 25). or individuals aged ≥ 60 years without co-morbidities. covid-19 confirmed by molecular or antigenic test for sars-cov-2 within up to 24 hours prior to screening and a maximum of 2 days after sample collection. viral syndrome with or without pneumonia and arterial o2 saturation > 94%. signing the free and informed consent form before any research procedures. willingness to use the proposed investigational treatment and follow the procedures provided for in the research.

diagnostic test for negative sars-cov2 associated with acute flu symptoms (patient with a negative test collected early and becomes positive a few days later is eligible, as long as it is < 07 days since the onset of flu symptoms). patients with an acute respiratory condition compatible with covid-19 treated in the primary care network and with a decision to be hospitalized. patients with acute respiratory symptoms due to other causes. dyspnea secondary to other acute and chronic respiratory causes or infections (eg, decompensated copd, acute bronchitis, pneumonia other than viral, primary pulmonary arterial hypertension). patients requiring hospitalization due to covid-19 or spo2 ≤ 93%. note: patients allocated to the fluvoxamine arm alone may be included if spo2 is below 94%, with no evidence of acute respiratory failure, provided that the attending physician decides to discharge the unit and continue treatment on an outpatient basis. exclusion criteria applicable to injectable medication arms: a. patients on chronic use of prednisone, prednisolone or other corticosteroids with doses > 10 mg/day equivalent to prednisone. exclusion criteria applicable to 07-day treatment arms: abnormal findings on physical examination: respiratory rate ≥ 25 sisters; blood pressure < 90/60 mmhg or > 160/100 mmhg; weight < 45 kg; recent episodes of vomiting within the last 24 hours or recurrent diarrhea or serum potassium below 3.5 meq/l. severe organ damage that requires resuscitation and ongoing treatment. chronic corticosteroid use with equivalent prednisone doses of > 40 mg/day immunosuppressive treatment in progress history of known pulmonary arterial hypertension or pulmonary fibrosis patients who have received a previous dose of sars-cov-2 vaccine use of serotonin reuptake inhibitors (all). exclusion criteria applicable to 10-day treatment arms: chronic use of serotonin reuptake inhibitors other than sertraline chronic corticosteroid use with equivalent prednisone doses of > 40 mg/day; continued use of monoamine oxidative inhibitors (maoi): phenelzine, tranylcypromine, selegiline, isocarboxazid, moclobemide. patients with severe psychiatric disorders - schizophrenia, uncontrolled bipolar disorders, major depression with suicidal ideation. pregnant or breastfeeding patients. history of severe ventricular cardiac arrhythmia (ventricular tachycardia, recovered ventricular fibrillation patients) or long qt syndrome. known history of decompensated heart failure (nyha iii or iv), recent myocardial infarction (event < 90 days of screening), unstable angina, recent coronary bypass surgery (procedure < 90 days of screening), recent stroke ( event < 90 days from screening), symptomatic carotid disease, or moderate to severe mitral or aortic stenosis. surgical procedure or hospitalization planned (for other indications) to occur during treatment or up to 5 days after the last dose of study medication. current daily and/or uncontrolled alcohol consumption, which, in the investigator's view, could compromise participation in the study. history of seizures in the last month or uncontrolled seizures. clinical history of moderate to severe hepatic impairment or hepatic cirrhosis with child-pugh c classification. patients with known serious degenerative neurological diseases and/or serious mental illnesses as assessed by the investigator. inability of the patient or representative to give consent or adhere to the procedures proposed in the protocol. any clinical conditions, including psychiatric conditions, which, in the investigator's view, could prevent the use of research drugs. known hypersensitivity and/or intolerance to fluvoxamine, budesonide, pegylated interferon lambda and fluoxetine. use of drugs which have a known interaction with fluvoxamine, budesonide, pegylated interferon lambda and fluoxetine. inability to use the drugs and formulations provided for in this research.

6

Cardresearch

18

100

Brazil

Mild disease at enrollment

1: Mild disease at enrollment

6246

Rate of fluvoxamine + budesonide, fluoxetine + budesonide, peginterferon Lambda and fluvoxamine in changing the COVID-19 associated mortality.;Rate of fluvoxamine + budesonide, fluoxetine + budesonide, peginterferon Lambda and fluvoxamine in changing the need for Hospitalization due to COVID-19 progression and related complications, including lower respiratory tract infection (LRTI);Rate of fluvoxamine + budesonide, fluoxetine + budesonide, peginterferon Lambda, fluvoxamine in changing the need for emergency care AND observation for more than 06 hours due to the worsening of COVID-19;

None

Phase 3

[{"arm_notes": "nan", "treatment_id": 242, "treatment_name": "Budesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 520, "treatment_name": "Fluoxetine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 522, "treatment_name": "Fluvoxamine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1846, "treatment_name": "Peginterferon lambda", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]