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History of Changes for Study: NCT04727424
Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms
Latest version (submitted July 3, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 26, 2021 None (earliest Version on record)
2 March 21, 2021 Outcome Measures, Arms and Interventions, Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
3 July 5, 2021 Arms and Interventions, Outcome Measures, Contacts/Locations, Study Design, Study Status, Study Identification, Eligibility, Conditions and Sponsor/Collaborators
4 January 15, 2022 Arms and Interventions, Study Status, References, Outcome Measures, Study Design, Contacts/Locations, Eligibility and Conditions
5 July 3, 2022 Arms and Interventions, References, Outcome Measures, Study Design, Study Description, Eligibility, Conditions, Study Status and Study Identification
Comparison Format:

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Changes (Side-by-Side) for Study: NCT04727424
March 21, 2021 (v2) -- July 5, 2021 (v3)

Changes in: Study Identification, Study Status, Sponsor/Collaborators, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: TOGETHER_2 TOGETHER_2
Brief Title: Repurposed Approved Therapies for Outpatient Treatment of Patients With Early-Onset COVID-19 and Mild Symptoms Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms
Official Title: A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Fluvoxamine, Ivermectin and Metformin in Reducing Hospitalization of Patients With Mild COVID-19 and a High Risk of Complications A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Fluvoxamine, Ivermectin, Doxasozin and Interferon Lambda 1A in Mild COVID-19 and High Risk of Complications
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2021 July 2021
Overall Status: RecruitingRecruiting
Study Start: January 19, 2021 January 19, 2021
Primary Completion: February 1, 2022 [Anticipated] February 1, 2022 [Anticipated]
Study Completion: March 1, 2022 [Anticipated] March 1, 2022 [Anticipated]
First Submitted: January 25, 2021 January 25, 2021
First Submitted that
Met QC Criteria:
January 26, 2021 January 26, 2021
First Posted: January 27, 2021 [Actual] January 27, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 21, 2021 July 5, 2021
Last Update Posted: March 24, 2021 [Actual] July 8, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Cardresearch Cardresearch
Responsible Party: Sponsor Sponsor
Collaborators: Cytel Inc.
McMaster University
Fastgrants
Eiger BioPharmaceuticals
RainWater Foundation
Open or close this module Oversight
U.S. FDA-regulated Drug: NoNo
U.S. FDA-regulated Device: NoNo
Data Monitoring: Yes Yes
Open or close this module Study Description
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, Metformin and Ivermectin in SARS-CoV-2 infections and observational studies have suggested a reduced complications in patients with COVID-19 disease. 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.
Detailed 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.

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.

Open or close this module Conditions
Conditions: Covid19
SARS-Associated Coronavirus
Covid19
SARS-Associated Coronavirus
Keywords: COVID-19
Randomized study
Fluvoxamine
Ivermectin
Metformin
COVID-19
Randomized study
Fluvoxamine
Ivermectin
Doxasozin
Peginterferon Lambda
Peginterferon Beta
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 3Phase 3
Interventional Study Model: Parallel Assignment Parallel Assignment

Patients will be randomly allocated to one of four treatment arms in a 1:1:1:1 ratio:

  1. Fluvoxamine
  2. Ivermectin
  3. Metformin
  4. Placebo. We will use a centralized random allocation schedule, generated by computer and implemented using an online remote access system. Randomization will be stratified by participating basic health unit.

Patients will be randomly allocated to one of six treatment arms in a 1:1:1:1:1:1 ratio:

  1. Fluvoxamine
  2. Ivermectin
  3. Doxazosin
  4. Peginterferon Lambda
  5. Peginterferon Beta
  6. Placebo We will use a centralized random allocation schedule, generated by computer and stratified by site and age.
Number of Arms: 46
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: RandomizedRandomized
Enrollment: 2724 [Anticipated] 3645 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Fluvoxamine Maleate

Fluvoxamine 100 mg oral tablets: One tablet right after randomization followed by 100 mg twice a day for the following 09 days Fluvoxamine 100 mg oral tablets:

One tablet right after randomization (Day 0) followed by 100 mg BID for the following 09 days

Drug: Fluvoxamine Maleate 100 MG [Luvox]
One tablet every 12 hours since randomization through day 09.
Active Comparator: Metformin HCL Doxasoxin

Metformin HCL 750 mg extended release tablets: one tablet right after randomization followed by 750 mg twice a day for the following 09 days Dosaxozin oral tablets (1 or 2 mg):

One tablet right after randomization (Day 0) until Day 3, when uptritation of tablets will happen as per protocol, up to 4 pills daily (08 mg/ day) ending on Day 13.

Drug: Metformin Extended Release Doxazosin 2 Mg Oral Tablet
One 750 mg extended release tablet every 12 hours since randomization through day 09. One to four tablets daily, as per uptritation schedule up to 08 mg/ day since randomization through day 13.
Active Comparator: Ivermectin

Ivermectin 06 mg oral tablets or 5, 10 and 20 mg sublingual waffle: Ivermectin 06 mg oral tablets:

Tablets or waffles started right after randomization using the dosing regimen of a medium (Day 0; 400mcg/ kg up to 90 kg weight dosing), administered once a day for three 03 consecutive days (including randomization day) days.

Drug: Ivermectin 06 mg Oral Tablet
Oral tablets administered once a day for three consecutive days (as of randomization day 0).
Drug: Ivermectin oral tablets or sublingual waffles
Tablets or waffles will be started right after randomization using the dosing regimen of a medium 400mcg/ kg up to 90 kg weight, administered once a day for three consecutive days (including randomization day).
Placebo Comparator: Placebo (talc) Placebo

Placebo SC normal saline syringe (single day dosing schedule):

Matching syringes containing 0,5 ml normal saline will be administered by SC route just after randomization Day 0 (single dose SC administration).

Placebo oral tablets: one tablet right after randomization followed by one tablet twice a day for the following 09 days;

OR

Placebo oral tablets or placebo sublingual waffles: Placebo oral tablets (3-day dosing schedule):

Matching tablets or waffles started right after randomization using the dosing regimen of a medium 400mcg/ kg up to 90 kg weight, administered once a day for three consecutive days (including randomization day, which is designed as Day 0).

OR

Placebo oral tablets (10-day dosing schedule):

Matching tablets started right 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)

OR

Placebo oral tablets (14-day dosing schedule):

Matching tablets started right after randomization (Day 0) until Day 3, when uptritation of tablets will happen as per protocol, up to 4 pills daily (08 mg/ day) ending on Day 13.

Drug: Placebo

Talc oral tablets:

One tablet every randomization since randomization through day 09

OR

talc oral tablets or placebo sublingual waffles: Matching tablets or waffles started right after randomization using the dosing regimen of a medium 400mcg/ kg up to 90 kg weight, administered once a day for three consecutive days (including randomization day).

Drug: Placebo

Placebo SC normal saline syringe (single day dosing schedule):

Matching syringes containing 0,5 ml normal saline will be administered by SC route just after randomization Day 0 (single dose SC administration).

OR

Placebo oral tablets (3-day dosing schedule):

Matching tablets started right after randomization using the dosing regimen of a medium 400mcg/ kg up to 90 kg weight, administered once a day for three consecutive days (including randomization day, which is designed as Day 0).

OR

Placebo oral tablets (10-day dosing schedule):

Matching tablets started right 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)

OR

Placebo oral tablets (14-day dosing schedule):

Matching tablets started right after randomization (Day 0) until Day 3, when uptritation of tablets will happen as per protocol, up to 4 pills daily (08 mg/ day) ending on Day 13.

Active Comparator: Peginterferon Lambda

Peginterferon Lambda 180 mcg syringe:

One syringe of Peginterferon Lambda will be administered by SC route just after randomization (Day 0 - single dose SC administration).

Drug: Peginterferon Lambda-1a
One syringe of 180 mcg of Peginterferon Lambda SC right after randomization Day 0 (single dose SC administration).
Active Comparator: Peginterferon Beta

Peginterferon Beta 125 mcg syringe:

One syringe of Peginterferon Beta 1A will be administered by SC route just after randomization (Day 0 - single dose SC administration).

Drug: Peginterferon Beta-1A Prefilled Syringe
One syringe of 125 mcg of Peginterferon Beta SC right after randomization Day 0 (single dose SC administration).
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of fluvoxamine, ivermectin and metformin in changing the need for emergency care AND observation for more than 06 hours due to the worsening of COVID-19;
[ Time Frame: 28 days ]

Evaluation of emergency visits and observation unit stay > 06 hours
Rate of fluvoxamine, ivermectin, doxasozin, peginterferon Lambda and peginterferon beta in changing the need for emergency care AND observation for more than 06 hours due to the worsening of COVID-19;
[ Time Frame: 28 days ]

Evaluation of emergency visits and observation unit stay > 06 hours
2. Rate of fluvoxamine, ivermectin and metformin in changing need for Hospitalization due to COVID-19 related complications, including lower respiratory tract infection (LRTI)
[ Time Frame: 28 days ]

Hospitalization due to COVID-19 progression
Rate of fluvoxamine, ivermectin, doxasozin, peginterferon lambda and peginterferon beta in changing need for Hospitalization due to COVID-19 progression and related complications, including lower respiratory tract infection (LRTI)
[ Time Frame: 28 days ]

Hospitalization due to COVID-19 progression and related complications
Secondary Outcome Measures:
1. Change in viral load on day 03 and 07 after randomization (first 600 enrolled participants)
[ Time Frame: Day 3 and Day 7 ]

Viral load
Change in viral load on day 03 and 07 after randomization (first 400 enrolled participants on the IV arms)
[ Time Frame: Day 3 and Day 7 ]

Viral load
2. Time to clinical changes (up to 28 days of randomization), defined as greater than 50% symptoms changing in reference to baseline symptoms)
[ Time Frame: Randomization through day 28 ]

time to > 50% clinical symptoms changes (self reported)
Time to clinical changes (up to 28 days of randomization), defined as greater than 50% symptoms changing in reference to baseline symptoms)
[ Time Frame: Randomization through day 28 ]

time to > 50% clinical symptoms changes as reported on baseline visit (self reported)
3. Time to clinical failure, defined as time to need for hospitalization due to the clinical progression of COVID-19
[ Time Frame: Randomization through day 28 ]

Time to hospitalization
Time to clinical failure, defined as time to need for hospitalization due to the clinical progression of COVID-19 or associated complications.
[ Time Frame: Randomization through day 28 ]

Time to hospitalization
4. Number of days with respiratory symptoms since randomization
[ Time Frame: Randomization through day 28 ]

Days with symptoms
Number of days with respiratory symptoms since randomization
[ Time Frame: Randomization through day 28 ]

Days with symptoms
5. Rate of all-cause hospitalizations
[ Time Frame: Randomization through day 28 ]

All cause hospitalizations
Rate of all-cause hospitalizations
[ Time Frame: Randomization through day 28 ]

All cause hospitalizations
6. Rate of COVID-19 related hospitalizations
[ Time Frame: Randomization through day 28 ]

COVID-19 hospitalizations
Rate of COVID-19 related hospitalizations
[ Time Frame: Randomization through day 28 ]

COVID-19 hospitalizations
7. All-Cause Death
[ Time Frame: Randomization through day 28 ]

Death all cause
Number of days on Mechanical Ventilator
[ Time Frame: Randomization through day 28 ]

Number of days on mechanical Ventilator
8. Cardiovascular death
[ Time Frame: Randomization through day 28 ]

Cardiovascular death
Number of Days on Intensive Care Unit
[ Time Frame: Randomization through day 28 ]

Number of days on Intensive Care Unit
9. Respiratory death
[ Time Frame: Randomization through day 28 ]

REspiratory death
Number of days on hospitalizations
[ Time Frame: Randomization through day 28 ]

Number of days on Hospitalization
10. Health and Functioning after COVID-19 disease
[ Time Frame: Day 14 and Day 28 ]

Self evaluation of health functioning post COVID using Promis Global Health Score. Short term scale is a 10 item patient-reported questionnaire using response options as a 5-point and one 11 point rating scale. Higher scores means better global health.
Health and Functioning after COVID-19 disease
[ Time Frame: Day 14 and Day 28 ]

Self evaluation of health functioning post COVID using Promis Global Health Score. Short term scale is a 10 item patient-reported questionnaire using response options as a 5-point and one 11 point rating scale. Higher scores means better global health.
11. WHO ordinal scale for clinical improvement
[ Time Frame: Randomization through day 28 ]

An 8 item Ordinal Scale for clinical status on COVID-19. Higher numbers means worse clinical status.
WHO ordinal scale for clinical improvement
[ Time Frame: Randomization through day 28 ]

An 8 item Ordinal Scale for clinical status on COVID-19. Higher numbers means worse clinical status.
12. Adverse Events
[ Time Frame: randomization through day 28 ]

Adverse events
Number os days on respiratory Symptoms
[ Time Frame: randomization through day 28 ]

Number of days on respiratory symptoms
13. Adherence of Study drug
[ Time Frame: Randomization through day 10 ]

Percentage of adherence on Study drug
Adherence of Study drug
[ Time Frame: Randomization through day 14 ]

Percentage of adherence on Study drug
Open or close this module Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: All All
Gender Based: Yes Yes
Gender will be assumed as patient self-reported Gender will be assumed as patient self-reported
Accepts Healthy Volunteers: NoNo
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. All patient need to have at lease ONE enhancement factor:
    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. Smoking
    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 at least 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
  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. Patients with history of SARS-CoV-2 vaccine shot;
  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. Acute Flu-Like condition presenting with at least ONE of the criteria below:
    1. Respiratory Rate> 28 / min;
    2. SaO2 <90% or <93% in nasal oxygen therapy at 10 l / min;
    3. PaO2 / FIO2 <300 mmHg
  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. Use of iodinated contrasts during start of treatment through D14;
    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. History of diabetic ketoacidosis or clinical condition that maintains persistent acidosis
  14. Surgical procedure or use of contrast 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 or sublingual medications;
  22. Inability to follow protocol-related procedures

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
Open or close this module Contacts/Locations
Central Contact Person: Gilmar Reis, MD, PhD
Telephone: +553132416574
Email: administrador@cardresearch.org
Gilmar Reis, MD, PhD
Telephone: +553132416574
Email: administrador@cardresearch.org
Central Contact Backup: Eduardo Santos, MD, PhD
Telephone: +553132416574
Email: duduaugusto1@yahoo.com.br
Eduardo Santos, MD, PhD
Telephone: +553132416574
Email: duduaugusto1@yahoo.com.br
Study Officials: Gilmar Reis, MD,PhD.
Study Chair
Cardresearch - Cardiologia Assistencial e de Pesquisa
Gilmar Reis, MD,PhD.
Study Chair
Cardresearch - Cardiologia Assistencial e de Pesquisa
Edward J Mills, FRCP
Study Director
McMaster University
Edward J Mills, FRCP
Study Director
McMaster University
Locations: Brazil, MG
City of Betim
[Recruiting]
Betim, MG, Brazil, 32550770
Contact:Contact: Daniela C Medeiros, MD,PhD
Contact:Contact: Tainara S Vieira
Hospital e Maternidade Santa Rita
[Recruiting]
Contagem, MG, Brazil, 32215000
Contact:Contact: Thiago S Ferreira, MD
City of Governador Valadares
[Recruiting]
Governador Valadares, MG, Brazil, 35010-000
Contact:Contact: Adhemar DF Neto, MD, PhD
Contact:Contact: Marina L Marques, SC
Brazil, MG
City of Ibirité
[Recruiting]
Ibirité, MG, Brazil, 30240528
Contact:Contact: Aline Milagres, RN
Contact:Contact: Carla Silva, SC hsfapesq@cardresearch.org
City of Ibirité
[Recruiting]
Ibirité, MG, Brazil, 30240528
Contact:Contact: Aline Milagres, RN
Contact:Contact: Carla Silva, SC hsfapesq@cardresearch.org
City of Nova Lima
[Recruiting]
Nova Lima, MG, Brazil, 34000000
Contact:Contact: Leticia F Costa, RN
Contact:Contact: Rosemary M Silva
City of Santa Luzia
[Recruiting]
Santa Luzia, MG, Brazil, 33105160
Contact:Contact: Eduardo Augusto SM Silva, MD, PhD
Contact:Contact: Vitoria HS Campos, SC
City of Sete Lagoas
[Recruiting]
Sete Lagoas, MG, Brazil, 35700-000
Contact:Contact: Vinicius Correa, MD
Contact:Contact: Castilho Vitor Quirino, SC vitor-quirino@hotmail.com
City of Sete Lagoas
[Recruiting]
Sete Lagoas, MG, Brazil, 35700-000
Contact:Contact: Vinicius A Correa, MD
Contact:Contact: Castilho Vitor Quirino, SC vitor-quirino@hotmail.com
Brazil, Minas GeraisBrazil, Minas Gerais
CARDRESEARCH - Cardiologia Assistencial e de Pesquisa
[Recruiting]
Belo Horizonte, Minas Gerais, Brazil, 30150240
Contact:Contact: Izabel Silva, SC 553132416574 coordpesq@cardresearch.org
Contact:Principal Investigator: Gilmar Reis, MD,PhD
CARDRESEARCH - Cardiologia Assistencial e de Pesquisa
[Recruiting]
Belo Horizonte, Minas Gerais, Brazil, 30150240
Contact:Contact: Izabel Silva, SC 553132416574 coordpesq@cardresearch.org
Contact:Principal Investigator: Gilmar Reis, MD,PhD
City of Brumadinho
[Recruiting]
Brumadinho, Minas Gerais, Brazil, 35.460-000
Contact:Contact: Eduardo Calegari, MD
Contact:Principal Investigator: Eduardo Calegari, MD
City of Brumadinho
[Recruiting]
Brumadinho, Minas Gerais, Brazil, 35.460-000
Contact:Contact: Eduardo D Calegari, MD
Contact:Principal Investigator: Eduardo Calegari, MD
Centro Universitário FIPMOC
[Recruiting]
Montes Claros, Minas Gerais, Brazil, 39.408-007
Contact:Contact: Ana Maria, MD
Contact:Principal Investigator: Ana Maria R Nogueira, MD
Contact:Sub-Investigator: Ana Paula FG Alvarenga, MD
Centro Universitário FIPMOC
[Recruiting]
Montes Claros, Minas Gerais, Brazil, 39.408-007
Contact:Contact: Ana Maria, MD
Contact:Principal Investigator: Ana Maria R Nogueira, MD
Contact:Sub-Investigator: Ana Paula FG Alvarenga, MD
Universidade Federal de Ouro Preto
[Not yet recruiting]
Ouro Preto, Minas Gerais, Brazil, 35400000
Contact:Contact: Leonardo Savassi, MD, PhD leosavassi@gmail.com
Contact:Principal Investigator: Leonardo Savassi, MD, PhD
Universidade Federal de Ouro Preto
[Recruiting]
Ouro Preto, Minas Gerais, Brazil, 35400000
Contact:Contact: Leonardo CM Savassi, MD, PhD leosavassi@gmail.com
Contact:Principal Investigator: Leonardo Savassi, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD: Yes
Patient tables and main data.
Yes
Patient tables and main data.
Supporting Information:
Statistical Analysis Plan (SAP)
Supporting Information:
Statistical Analysis Plan (SAP)
Time Frame:
As of protocol termination
Time Frame:
As of protocol termination
Access Criteria:
Upon request
Access Criteria:
Upon request
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