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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Fluvoxamine Plus Budesonide, Fluoxetine Plus Budesonide and Spirulin Platensis, in High Risk Patients With Mild COVID-19

Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms (NCT04727424) is a Phase 3 interventional studying Covid19 and SARS-Associated Coronavirus, sponsored by Cardresearch. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Covid19, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 7,819 participants makes this one of the larger Covid19 trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

A - Inclusion Criteria (except fluoxetine + budesonide and paracetamol arms): 1. Patients over 18 years old with the ability to provide free and willing to sign a consent form 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 kidney disease or on dialysis. 10. Patient with temperature measured at screening \> 38º C. 11. Patients with at least one of the following symptoms: Cough, Dyspnea, Ventilator-dependent chest pain or myalgias with limitation of daily activities (Criterion limited to 25% of randomizations) 12. Immunosuppressed patients/using corticosteroid therapy (equivalent to a maximum of 10 mg of prednisone per day) and/or immunosuppressive therapy) 13. Patients with a history of cancer in the last 5 years or currently undergoing oncological treatment 4. 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. 5. Willingness to use the proposed investigative treatment and follow the protocol-related procedures foreseen in the research. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 kidney disease or on dialysis. 10. Patient with temperature measured at screening \> 38º C. 11. Patients with at least one of the following symptoms: Cough, Dyspnea, Ventilator-dependent chest pain or myalgias with limitation of daily activities (Criterion limited to 25% of randomizations) 12. Immunosuppressed patients/using corticosteroid therapy (equivalent to a maximum of 10 mg of prednisone per day) and/or immunosuppressive therapy) 13. Patients with a history of cancer in the last 5 years or currently undergoing oncological treatment 4. 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. 5. Willingness to use the proposed investigative treatment and follow the protocol-related procedures foreseen in the research. 6. Signing the Free and Informed Consent Form before any research procedures B - Inclusion criteria for the Fluoxetine + Budesonide combination arm (07 days of treatment - partnership with the "ANTICOV Consortium"): 1. Patients over 18 years of age with the ability to provide free and informed consent. 2. 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. 3. Patients over 18 years of age and a history of at least ONE of the following criteria. 1. 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 2. Individuals aged ≥ 60 years without co-morbidities. 4\) 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. 5\) Viral syndrome with or without pneumonia and arterial O2 saturation \> 94%. 6\) Signing the Free and Informed Consent Form before any research procedures. 7\) Willingness to use the proposed investigational treatment and follow the procedures provided for in the research. Exclusion Criteria: 1. Negative diagnostic test for SARS-CoV2 associated with acute flu-like symptoms (patients with a negative test taken early and becoming positive a few days later are eligible, as long as they are \< 07 days from the onset of flu-like symptoms); 2. Patients with an acute respiratory condition compatible with COVID-19 treated in the primary care network and with a decision to be hospitalized; 3. Patients with acute respiratory symptoms due to other causes; 4. Dyspnea secondary to other acute and chronic respiratory causes or infections (e.g. decompensated COPD, Acute bronchitis, Pneumonia other than viral, Primary pulmonary arterial hypertension); 5. Patients requiring hospitalization due to COVID-19 or SpO2 ≤ 93%. 6. Exclusion criteria applicable to the 7-day treatment arms: 1. Abnormal findings on physical examination: Respiratory rate ≥ 25 irm; blood pressure \< 90/ 60 mmHg or \> 160/ 100 mmHg; Weight \< 45 kg; recent episodes of vomiting in the last 24 hours or diarrhea \> 3 episodes in the last 24 hours or serum potassium below 3.5 mEq/L. 2. Serious injury to any organ that requires resuscitation and continuous treatment. 3. Use of chronic systemic corticosteroid therapy with prednisone equivalent doses of \> 40 mg/day 4. Ongoing immunosuppressive treatment 5. History of known pulmonary arterial hypertension or pulmonary fibrosis 6. Patients previously vaccinated with two doses for SARS-CoV-2, with the last dose administered less than 180 days after screening; Patients with a single dose of Janssen SARS-CoV-2 vaccine received (except Janssen vaccine) and unvaccinated patients can participate regardless of the period. 7. Use of serotonin reuptake inhibitors (all) 8. Patients vaccinated for SARS-CoV-2 (complete vaccination - 02 doses) within 06 months of the last dose before randomization or patients who received a "booster" dose at any time before randomization. 9. For any new antiviral included in the study, prior treatment with the antiviral, presence of contraindication to its use or concomitant intake of medication prohibited for its use. 10. Enrolled in other clinical trials with unregistered medicines or with a registered medicine that may interact with any of the study PIs or contraindicated as concomitant treatment in the last 3 months before screening. 7. Exclusion criteria applicable to the 10-day treatment arm: A. Chronic use of serotonin reuptake inhibitors other than sertraline B. Chronic use of corticosteroid therapy with prednisone equivalent doses of \> 40 mg/day 8. Exclusion criteria applicable to the 14-day treatment arm: Patients with phenylketonuria; 9. Continued use of monoamine oxidation inhibitors (MAOIs): Phenelzine, Tranylcypromine, Selegiline, Isocarboxazid, moclobemide; 10. Patients with severe psychiatric disorders - schizophrenia, uncontrolled bipolar disorders, major depression with suicidal ideation. 11. Pregnant or breastfeeding patients; 12. History of severe ventricular cardiac arrhythmia (Ventricular Tachycardia, recovered ventricular fibrillation patients) or Long QT Syndrome; 13. Known history of decompensated heart failure (NYHA III or IV), recent myocardial infarction (event \< 90 days from screening), unstable angina, recent coronary bypass surgery (procedure \< 90 days from screening), recent stroke ( event \< 90 days from screening), symptomatic carotid disease, or mitral or aortic stenosis of moderate to severe intensity; 14. Surgical procedure or hospitalization planned (for other indications) to occur during treatment or up to 5 days after the last dose of study medication; 15. Current daily and/or uncontrolled alcohol consumption, which in the investigator's view could compromise participation in the study; 16. History of seizures in the last month or uncontrolled seizures; 17. Clinical history of moderate to severe hepatic impairment or liver cirrhosis with Child-Pugh classification C; 18. Patients with known severe degenerative neurological diseases and/or serious mental illnesses as assessed by the investigator; 19. Inability of the patient or representative to give consent or adhere to the procedures proposed in the protocol; 20. Any clinical conditions, including psychiatric conditions, which in the investigator's view could be an impediment to the use of research medications; 21. Known hypersensitivity and/or intolerance to Spirulin Platensis, Budesonide, Fluvoxamine and Fluoxetine; 22. Use of medications which have a known interaction with Spirulin platensis, Budesonide, Fluvoxamine and Fluoxetine; 23. Inability to use the medications and formulations provided for in this research;

Treatments Being Tested

DIETARY_SUPPLEMENT

Spirulin Platensis

Two tablets every 12 hours since randomization through day 09 following randomization

DRUG

Budesonide Powder

One Fluvoxamine tablet every 12 hours since randomization through day 09. PLUS 01 Budesonide powder (inhalation) every 12 hours since randomization through day 09.

DRUG

Fluoxetine 20 MG

Two Fluoxetine tablets every day starting just after randomization through day 07. PLUS 01 Budesonide powder (inhalation) every 12 hours since randomization through day 07.

DRUG

Placebo

Placebo oral tablets (10-day schedule): Matching tablets started after randomization using the dosing regimen of 01 tablet every 12 hs starting at Randomization Day (Day 0) until end of Day 09 (total of 10 day schedule) PLUS Placebo Inhalation Therapy: One dosing (inhalation puff) right after randomization (Day 0) followed by one puff BID for the following 09 days OR Paracetamol (07-day schedule - active comparator): Paracetamol 500 mg tablets started after randomization using the dosing regimen of 01 tablet BID starting at Rand. Day (Day 0) until end of Day 06 (total of 07 days schedule - ANTICOV Arm) OR Matching tablets started after randomization using the dosing regimen of 02 tablets every 12 hs starting at Randomization Day (Day 0) until end of Day 09 (total of 10 day schedule)

Locations (12)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

CARDRESEARCH - Cardiologia Assistencial e de Pesquisa
Belo Horizonte, Minas Gerais, Brazil
City of Betim
Betim, Minas Gerais, Brazil
City of Brumadinho
Brumadinho, Minas Gerais, Brazil
Hospital e Maternidade Santa Rita
Contagem, Minas Gerais, Brazil
City of Governador Valadares
Governador Valadares, Minas Gerais, Brazil
City of Ibirité
Ibirité, Minas Gerais, Brazil
City of Igarapé
Igarapé, Minas Gerais, Brazil
Centro Universitário FIPMOC
Montes Claros, Minas Gerais, Brazil
City of Nova Lima
Nova Lima, Minas Gerais, Brazil
Universidade Federal de Ouro Preto
Ouro Preto, Minas Gerais, Brazil
City of Santa Luzia
Santa Luzia, Minas Gerais, Brazil
City of Sete Lagoas
Sete Lagoas, Minas Gerais, Brazil

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04727424), the sponsor (Cardresearch), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04727424 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04727424?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04727424?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04727424. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04727424. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.