Actively Recruiting
Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms
Led by Cardresearch · Updated on 2024-05-08
7819
Participants Needed
12
Research Sites
179 weeks
Total Duration
On this page
Sponsors
C
Cardresearch
Lead Sponsor
C
Cytel Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older able to provide informed consent
- Acute flu-like symptoms lasting less than 7 days
- Presence of at least one risk factor: age over 50, diabetes requiring medication, hypertension treated with medication, known cardiovascular disease, symptomatic lung disease or asthma, obesity (BMI > 30), transplant, chronic kidney disease stage IV or dialysis, temperature over 38ºC at screening, certain symptoms (cough, dyspnea, chest pain, myalgias), immunosuppression or corticosteroid use (up to 10 mg prednisone equivalent), history of cancer within 5 years or current cancer treatment
- Positive SARS-CoV-2 antigen or diagnostic test within 7 days of symptom onset
- Willingness to use study treatments and follow study procedures
- Signed informed consent form
You will not qualify if you...
- Negative SARS-CoV-2 test with acute flu-like symptoms (unless later positive within 7 days of symptoms)
- Acute respiratory illness expected to require hospitalization
- Respiratory symptoms caused by other conditions
- Dyspnea due to other respiratory diseases or infections
- Hospitalization required or oxygen saturation ≤ 93%
- Abnormal vital signs or serious organ injury requiring intensive treatment (specific to 7-day treatment arms)
- Use of high-dose corticosteroids (>40 mg prednisone equivalent daily) or ongoing immunosuppressive therapy
- History of pulmonary hypertension or pulmonary fibrosis
- Recent complete COVID-19 vaccination within 6 months or booster dose prior to randomization
- Use of serotonin reuptake inhibitors (except sertraline for some arms)
- Participation in other clinical trials with interacting medications within 3 months
- Phenylketonuria (for 14-day treatment arm)
- Use of monoamine oxidase inhibitors
- Severe psychiatric disorders
- Pregnant or breastfeeding
- History of severe cardiac arrhythmias or certain heart diseases
- Planned surgery or hospitalization during treatment or shortly after
- Uncontrolled alcohol use
- Recent or uncontrolled seizures
- Severe liver disease or cirrhosis
- Severe neurological or mental illnesses
- Inability to consent or follow study procedures
- Hypersensitivity or intolerance to study medications
- Use of medications interacting with study drugs
- Inability to use study medications and formulations provided
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
CARDRESEARCH - Cardiologia Assistencial e de Pesquisa
Belo Horizonte, Minas Gerais, Brazil, 30150240
Actively Recruiting
2
City of Betim
Betim, Minas Gerais, Brazil, 32550770
Actively Recruiting
3
City of Brumadinho
Brumadinho, Minas Gerais, Brazil, 35.460-000
Not Yet Recruiting
4
Hospital e Maternidade Santa Rita
Contagem, Minas Gerais, Brazil, 32215000
Actively Recruiting
5
City of Governador Valadares
Governador Valadares, Minas Gerais, Brazil, 35010-000
Actively Recruiting
6
City of Ibirité
Ibirité, Minas Gerais, Brazil, 30240528
Actively Recruiting
7
City of Igarapé
Igarapé, Minas Gerais, Brazil, 32900-000
Actively Recruiting
8
Centro Universitário FIPMOC
Montes Claros, Minas Gerais, Brazil, 39.408-007
Actively Recruiting
9
City of Nova Lima
Nova Lima, Minas Gerais, Brazil, 34000000
Actively Recruiting
10
Universidade Federal de Ouro Preto
Ouro Preto, Minas Gerais, Brazil, 35400000
Actively Recruiting
11
City of Santa Luzia
Santa Luzia, Minas Gerais, Brazil, 33105160
Actively Recruiting
12
City of Sete Lagoas
Sete Lagoas, Minas Gerais, Brazil, 35700-000
Actively Recruiting
Research Team
G
Gilmar Reis, MD, PhD
CONTACT
E
Eduardo Santos, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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