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Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19 (IDEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04425863
Recruitment Status : Completed
First Posted : June 11, 2020
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Hector E Carvallo, Eurnekian Public Hospital

Brief Summary:
The associated use of Ivermectin, aspirin, dexamethasone, and enoxaparin (in different combinations and doses) will reduce the impact of COVID infection 19, the need of admission to the intensive care unit, and mortality.

Condition or disease Intervention/treatment
Severe Acute Respiratory Syndrome Ventilation Pneumonitis Drug: Ivermectin 5 MG/ML oral solution, Aspirin 250 mg tablets Other: Ivermectin 5 mg/mL oral solution, Dexamethasone 4-mg injection, Aspirin 250 mg tablets Other: Ivermectin 5 MG/ML oral solution, Dexamethasone 4-mg injection, Enoxaparin injection. Inpatient treatment with mechanical ventilation in ICU.

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Study Type : Observational
Actual Enrollment : 167 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of covid19
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 30, 2020


Group/Cohort Intervention/treatment
Mild cases
This group includes patients diagnosed positive for COVID-19 via rtPCR and presenting only mild symptoms such as: fever not above 38.5 °C; isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (93 - 96 %), dyspnea without matter, polymyoarthralgias, persistent headache, abdominal pain.
Drug: Ivermectin 5 MG/ML oral solution, Aspirin 250 mg tablets
24 mg oral Ivermectin on days 0 and 7 and 1 Aspirin tablet daily for 30 days. Outpatient treatment.
Other Name: Outpatient treatment

Moderate cases
This group includes patients diagnosed positive for COVID-19 via rtPCR and presenting either: 3 severe symptoms (i.e. fever above 38.5 °C, diarrhea with more than 3 daily depositions, flictenular conjunctivitis, strong desaturation (92% or less), tachypnea (FR> 25 / minute) or 2 severe symptoms + 2 mild symptoms (fever not above 38.5 °C; isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (93 - 96 %), dyspnea without matter, polymyoarthralgias, persistent headache, abdominal pain)
Other: Ivermectin 5 mg/mL oral solution, Dexamethasone 4-mg injection, Aspirin 250 mg tablets
36 mg oral Ivermectin on days 0 and 7; 1 daily injection of 4-mg Dexamethasone until discharge, 1 Aspirin tablet daily for 30 days. Inpatient treatment in ward care, including Low flow washed oxygen or oxygen concentrator
Other Name: Inpatient treatment in ward care

Severe cases
This group includes patients diagnosed positive for COVID-19 via rtPCR and presenting either: 4 severe symptoms or 3 severe symptoms and not less than 2 mild symptoms or clinical signs of bilateral viral pneumonia
Other: Ivermectin 5 MG/ML oral solution, Dexamethasone 4-mg injection, Enoxaparin injection. Inpatient treatment with mechanical ventilation in ICU.
48 mg oral Ivermectin on days 0 and 7; 1 daily injection of 4-mg Dexamethasone until discharge, Enoxaparin 100 IU/kg (ca. 1 mg/kg) daily until transfer to ward care. Then continue with inpatient treatment in ward care.
Other Name: Inpatient treatment in ICU




Primary Outcome Measures :
  1. Patients Who Improved Their Condition or Did Not Worsen it [ Time Frame: 7 days ]
    Number of patients who did not go to a more severe stage of disease or die (i.e. they neither go from mild to moderate or severe, nor go from moderate to severe or die, if they had been already enrolled in a severe condition)

  2. ICU-treated Patients After 2-week Treatment [ Time Frame: 14 days ]
    Number of patients needing ICU-treatment including mechanical ventilation after 2-week treatment

  3. Mortality [ Time Frame: 30 days ]
    Patients who died within 30 days after enrollment

  4. Patients Needing Drug Dose Adjustment [ Time Frame: 14 days ]
    Patients who needed dose adjustment of any of the drugs involved in the treatment protocol

  5. Adverse Events [ Time Frame: 14 days ]
    Patient presenting serious adverse events



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients bothe genders, ages 5 or up, non pregnant, capable of accepting participation in trial (granted by signed premission), and affected by COVID 19
Criteria

Inclusion Criteria:

patients with positive oral/nasal swabs

Exclusion Criteria:

Children under 5 years old Pregnant women Previous reports of allergy to any of the drugs used in the clinical trial


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04425863


Locations
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Argentina
Hospital Eurnekian
Buenos Aires, Argentina, 1802
Sponsors and Collaborators
Eurnekian Public Hospital
Investigators
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Study Chair: Alfredo Secchi, M.D. President Ethical Commitee, Hospital Eurnekian
  Study Documents (Full-Text)

Documents provided by Hector E Carvallo, Eurnekian Public Hospital:
Publications:
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Responsible Party: Hector E Carvallo, Principal investigator, Eurnekian Public Hospital
ClinicalTrials.gov Identifier: NCT04425863    
Other Study ID Numbers: IDEA
First Posted: June 11, 2020    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Personal data will remain secret. Only clinical descriptions (age, gender, co-morbidities, evolution, outcomes will be released

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hector E Carvallo, Eurnekian Public Hospital:
COVID 19 IVERMECTIN ASPIRIN DEXAMETASONE ENOXAPARIN
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Pneumonia
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Aspirin
Ivermectin
Dexamethasone
Dexamethasone acetate
Enoxaparin
Pharmaceutical Solutions
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors