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Recruiting Phase 3 NCT04727424

Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms

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Trial Parameters

Condition Covid19
Sponsor Cardresearch
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 7,819
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-01-19
Completion 2024-06-01
Interventions
Spirulin PlatensisBudesonide PowderFluoxetine 20 MG

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Brief Summary

The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in patients with early-onset disease and mild symptoms. Experimental studies have demonstrated a potential anti-inflammatory role of Fluvoxamine, Fluoxetine, Budesonide and Spirulin Platensis in SARS-CoV-2 infections and observational studies have suggested a reduced complications in patients with COVID-19 disease.

Eligibility Criteria

A - Inclusion Criteria (except fluoxetine + budesonide and paracetamol arms): 1. Patients over 18 years old with the ability to provide free and informed consent 2. Acute Flu-Like symptoms \< 07 days. 3. Patients with at least ONE enhancement criteria: 1. The. Age \> 50 years old (does not need any of the other criteria) 2. Diabetes mellitus requiring oral medication or insulin 3. Systemic arterial hypertension requiring at least 01 oral medication for treatment 4. Known cardiovascular diseases (heart failure, congenital heart disease, valvular disease, coronary artery disease, cardiomyopathies under treatment, clinically manifest heart diseases with clinical repercussions) 5. Symptomatic and/or treated lung disease (emphysema, fibrosing diseases) 6. Patients with symptomatic asthma requiring chronic use of agents to control symptoms. 7. Obesity, defined as BMI \> 30 kg/m2 in weight and height information provided by the patient; 8. Transplant patients 9. Patient with stage IV chronic

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