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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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, Metformin and Ivermectin in SARS-CoV-2 infections and observational studies have suggested a reduced complications in patients with COVID-19 disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardresearch
• Collaborators: Cytel Inc.; Eiger BioPharmaceuticals; Fastgrants; McMaster University; RainWater Foundation
• Treatments: Doxazosin; Fluvoxamine; Ivermectin; Metformin

Criteria

Inclusion Criteria:

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. Age > 50 years;

2. Diabetes mellitus requiring oral medication or insulin

3. Systemic arterial hypertension requiring at least 01 oral medication for BP control;

4. Known cardiovascular diseases (heart failure, congenital heart disease, valvar heart valve disease, coronary artery disease, cardiomyopathies)

5. Symptomatic lung disease (emphysema, chronic bronchitis)

6. Symptomatic asthma patients requiring chronic use of agents for control of symptoms.

7. Fever > 38 C at baseline

8. Obesity, defined as BMI> 30 kg / m2 body weight

9. Transplanted patients

10. Patient with stage IV chronic kidney disease or on dialysis.

11. Immunosuppressed patients/ using corticosteroid therapy (equivalent to maximum 10 mg of prednisone per day) and/ or immunosuppressive therapy)

12. Patients with a history of cancer in the last 05 years or undergoing treatment of a current cancer

13. Chronic renal disease KDIGO IV or End-Stage Renal Disease on chronic ambulatory renal replacement therapy

14. Patients with important limitation of daily activities due to: Dyspnea, chest pain myalgia (limited to 25% of all randomizations)

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

Exclusion Criteria:

1. Negative SARS-CoV2 test.

2. Flu-like symptom onset 08 days or more.

3. Patients with COVID-19 being referred for hospitalization;

4. > 14 days of vaccination for SARS-CoV-2.

5. Patients with acute respiratory conditions due to other causes;

6. Dyspnea secondary to other acute and chronic respiratory causes or infections (eg:

Decompensated COPD, acute bronchitis, pneumonia, primary pulmonary arterial hypertension)

7. Patients with clinical evidence of moderate disease and/or hospitalization indication

8. Patients using serotonin reception inhibitors (Donepezil, Sertraline)

9. Use of the following medications in the last 14 days:

1. Monoamine Oxide Inhibitors (MAOIs): Phenelzine, Tranylcypromine, Selegiline, Isocarboxazide, moclobemide;

2. Alpha-1 antagonists, Sotalol, Clonidine, Phosphodiesterase 5 inhibitors, Methyldopa, Prazosin, terasozin, Doxazosin).

3. Use of antiretroviral agents

10. Patients with severe psychiatric disorders or major uncontrolled depression or controlled with any of the prohibited drugs (see above);

11. Pregnant or breastfeeding patients;

12. History of severe ventricular cardiac arrhythmia (ventricular tachycardia, patients with ventricular fibrillation recovered) or Long QT Syndrome;

13. Known history of symptomatic orothosthatic hypotension, syncope, postural orthostatic tachycardia syndrome (POTS), Neurally-mediated syncope on the last 12 months, less than 12 weeks of cerebrovascular accident, myocardial infarction, cardiovascular intervention, moderate to severe mitral or aortic stenosis.

14. Surgical procedure designed to occur during treatment or up to 04 days after the last dose of the study medication;

15. Current daily and / or uncontrolled alcoholism;

16. History of seizures in the last month or uncontrolled medical condition;

17. Clinical history of Liver Cirrhosis or Child-Pugh C classification;

18. Patients with known severe degenerative neurological diseases and / or diseases serious mental disorders;

19. Inability of the patient or representative to give consent or adhere to the procedures proposed in the protocol;

20. Known hypersensitivity and / or intolerance to Fluvoxamine, Ivermectin or Metformin;

21. Inability to take oral medications;

22. Inability to follow protocol-related procedures