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IVERMECTIN Aspirin Dexametasone and Enoxaparin as Treatment of Covid 19

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. Identifier: NCT04425863
Recruitment Status : Active, not recruiting
First Posted : June 11, 2020
Last Update Posted : June 23, 2020
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

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EVALUATION of Ivermectin Aspirin Dexametasone and Enoxaparin as Treatment of covid19
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Ivermectin has been reported to be a SARS-CoV-2 inhibitor. This activity is believed to be due to the dependence of many different RNA viruses on IMPα / β1 during infection. These reports suggested that the inhibitory activity of ivermectin nuclear transport may be effective against SARS-CoV-2, since they demonstrate that ivermectin has antiviral action against the clinical isolate of SARS-CoV-2 in vitro, with a single dose capable to control viral replication in 24-48 hours. in vitro
Drug: Ivermectin 5 MG/ML
Oral use, to be repeated a week later

Primary Outcome Measures :
  1. Illness development [ Time Frame: 7 days ]
    Considering healing and/or reducing symptoms and severity of initial presentation

  2. Reduction of need ICU admission [ Time Frame: 14 days ]
    Keeping the patient(s) out of ICU, as they do not need mechanical ventilation and/or special intensive care

  3. Reduction of mortality rate [ Time Frame: 30 days ]
    Preventing patient from dying

Secondary Outcome Measures :
  1. Optimyzing doses of drugs used in the clinical trial [ Time Frame: 14 days ]
    potential need of reducing or augmenting doses

  2. Adverse effects [ Time Frame: 14 days ]
    Outcome of adverse effects to one or more drugs used in the clinical trial

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT04425863

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Hospital Eurnekian
Buenos Aires, Argentina, 1802
Sponsors and Collaborators
Eurnekian Public Hospital
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Study Chair: Alfredo Secchi, M.D. President Ethical Commitee, Hospital Eurnekian
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Responsible Party: Hector E Carvallo, Principal investigator, Eurnekian Public Hospital Identifier: NCT04425863    
Other Study ID Numbers: IDEA
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 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:
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Antiparasitic Agents
Anti-Infective Agents