Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19 (IDEA)
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ClinicalTrials.gov Identifier: NCT04425863 |
Recruitment Status :
Completed
First Posted : June 11, 2020
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
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Condition or disease | Intervention/treatment |
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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. |

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 |
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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.
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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)
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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
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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 |
- 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)
- ICU-treated Patients After 2-week Treatment [ Time Frame: 14 days ]Number of patients needing ICU-treatment including mechanical ventilation after 2-week treatment
- Mortality [ Time Frame: 30 days ]Patients who died within 30 days after enrollment
- Patients Needing Drug Dose Adjustment [ Time Frame: 14 days ]Patients who needed dose adjustment of any of the drugs involved in the treatment protocol
- Adverse Events [ Time Frame: 14 days ]Patient presenting serious adverse events

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.
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 |
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

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
Argentina | |
Hospital Eurnekian | |
Buenos Aires, Argentina, 1802 |
Study Chair: | Alfredo Secchi, M.D. | President Ethical Commitee, Hospital Eurnekian |
Documents provided by Hector E Carvallo, Eurnekian Public Hospital:
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 |
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 |
COVID 19 IVERMECTIN ASPIRIN DEXAMETASONE ENOXAPARIN |
COVID-19 Severe Acute Respiratory Syndrome Pneumonia Respiratory Tract Infections Infections Pneumonia, Viral Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract 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 |