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

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    3645
  • sponsor
    Cardresearch
Updated on 16 July 2021

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.

Description

In December 2019 a series of viral pneumonia cases were reported in the city of Wuhan, China and a new subtype of coronavirus has been identified as the causative agent of this condition. On February 11, 2000 the disease has been characterized as COVID-19 and on March 11 the World Health Organization (WHO) declared a state of worldwide pandemic. On January 25, 2021 there are 98,794,942 cases and 2,124,193 documented deaths (global case-fatality ratio of 2.15%).

To date, no early treatment has been identified as effective in combating this disease which has been identified as with high morbidity and mortality. Epidemiological data suggest that despite development of vaccines we will have hundreds od thousands of cases in the next two years.

Thus, we propose the repositioning of three drugs which experimentally have shown anti-inflammatory activity against SARS-CoV2 and some clinical evidence derived from observational studies on reducing complications if used early on the disease, before inflammatory cascade is fully activated.

Details
Condition SARS coronavirus, Severe Acute Respiratory Syndrome, COVID19
Treatment Placebo, Metformin Extended Release Oral Tablet, Peginterferon Lambda-1a, Ivermectin Tablets, Fluvoxamine Maleate 100 MG [Luvox], Ivermectin oral tablets or sublingual waffles, Doxazosin 2 Mg Oral Tablet, Ivermectin 06 mg Oral Tablet, Peginterferon Beta-1A Prefilled Syringe
Clinical Study IdentifierNCT04727424
SponsorCardresearch
Last Modified on16 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Negative SARS-CoV2 test
Flu-like symptom onset 08 days or more
Patients with COVID-19 being referred for hospitalization
Patients with acute respiratory conditions due to other causes
Dyspnea secondary to other acute and chronic respiratory causes or infections (eg: Decompensated COPD, acute bronchitis, pneumonia, primary pulmonary arterial hypertension)
> 14 days of vaccination for SARS-CoV-2
Patients with clinical evidence of moderate disease and/or hospitalization indication
Patients using serotonin reception inhibitors (Donepezil, Sertraline)
Use of the following medications in the last 14 days
Alpha-1 antagonists, Sotalol, Clonidine, Phosphodiesterase 5 inhibitors, Methyldopa, Prazosin, terasozin, Doxazosin)
Monoamine Oxide Inhibitors (MAOIs): Phenelzine, Tranylcypromine, Selegiline, Isocarboxazide, moclobemide
Use of antiretroviral agents
Patients with severe psychiatric disorders or major uncontrolled depression or controlled with any of the prohibited drugs (see above)
Pregnant or breastfeeding patients
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
History of severe ventricular cardiac arrhythmia (ventricular tachycardia, patients with ventricular fibrillation recovered) or Long QT Syndrome
Surgical procedure designed to occur during treatment or up to 04 days after the last dose of the study medication
Current daily and / or uncontrolled alcoholism
History of seizures in the last month or uncontrolled medical condition
Clinical history of Liver Cirrhosis or Child-Pugh C classification
Patients with known severe degenerative neurological diseases and / or diseases serious mental disorders
Inability of the patient or representative to give consent or adhere to the procedures proposed in the protocol
Inability to take oral medications
Known hypersensitivity and / or intolerance to Fluvoxamine, Ivermectin or Metformin
Inability to follow protocol-related procedures
Clear my responses

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