Trial Outcomes & Findings for Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19 (NCT NCT04425863)
NCT ID: NCT04425863
Last Updated: 2020-10-19
Results Overview
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)
Recruitment status
COMPLETED
Target enrollment
167 participants
Primary outcome timeframe
7 days
Results posted on
2020-10-19
Participant Flow
Recruitment at Eurnekian Public Hospital
Participant milestones
| Measure |
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.
|
Moderate Cases
This group includes patients diagnosed positive for COVID-19 via rtPCR an presenting either: 3 severe symptoms (i.e. fever above 38.5 °C, diarrhea with more than 3 daily depositions, flictenular conjuntivitis, strong desaturation of 92 % or less, tachypnea with FR higher than 25/minute) or 2 severe symptoms + 2 mild symptoms (as already described for mild cases).
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
135
|
12
|
20
|
|
Overall Study
COMPLETED
|
135
|
12
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Moderate Cases
This group includes patients diagnosed positive for COVID-19 via rtPCR an presenting either: 3 severe symptoms (i.e. fever above 38.5 °C, diarrhea with more than 3 daily depositions, flictenular conjuntivitis, strong desaturation of 92 % or less, tachypnea with FR higher than 25/minute) or 2 severe symptoms + 2 mild symptoms (as already described for mild cases).
|
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.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19
Baseline characteristics by cohort
| Measure |
Mild Cases
n=135 Participants
Patients diagnosed positive for COVID-19 and presenting only mild symptoms.
|
Moderate Cases
n=12 Participants
Patients diagnosed positive for COVID-19 and presenting either 3 severe symptoms or 2 severe symptoms + 2 mild symptoms
|
Severe Cases
n=20 Participants
Patients diagnosed positive for COVID-19 and presenting either 4 severe symptoms or 3 severe symptoms + not less than 2 mild symptoms or clinical symptoms of bilateral viral pneumonia
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.7 years
n=99 Participants
|
59.7 years
n=107 Participants
|
59.7 years
n=206 Participants
|
56.5 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
83 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
135 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
167 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
135 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
167 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Argentina
|
135 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
167 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 7 daysNumber 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)
Outcome measures
| Measure |
Mild Cases
n=135 Participants
Patients diagnosed positive for COVID-19 via rtPCR and presenting only mild symptoms. No clinical signs of viral pneumonia.
|
Moderate Cases
n=12 Participants
Patients diagnosed positive for COVID-19 and presenting either 3 severe symptoms or 2 severe symptoms + 2 mild symptoms. Clinical sign of viral pneumonia.
|
Severe Cases
n=20 Participants
Patient diagnosed positive for COVID-19 presenting 4 severe symptoms or 3 severe symptoms and not less than 2 mild symptoms. Clinical signs of bilateral viral pneumonia.
|
|---|---|---|---|
|
Patients Who Improved Their Condition or Did Not Worsen it
|
135 Participants
|
12 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: 14 daysNumber of patients needing ICU-treatment including mechanical ventilation after 2-week treatment
Outcome measures
| Measure |
Mild Cases
n=135 Participants
Patients diagnosed positive for COVID-19 via rtPCR and presenting only mild symptoms. No clinical signs of viral pneumonia.
|
Moderate Cases
n=12 Participants
Patients diagnosed positive for COVID-19 and presenting either 3 severe symptoms or 2 severe symptoms + 2 mild symptoms. Clinical sign of viral pneumonia.
|
Severe Cases
n=20 Participants
Patient diagnosed positive for COVID-19 presenting 4 severe symptoms or 3 severe symptoms and not less than 2 mild symptoms. Clinical signs of bilateral viral pneumonia.
|
|---|---|---|---|
|
ICU-treated Patients After 2-week Treatment
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 30 daysPatients who died within 30 days after enrollment
Outcome measures
| Measure |
Mild Cases
n=135 Participants
Patients diagnosed positive for COVID-19 via rtPCR and presenting only mild symptoms. No clinical signs of viral pneumonia.
|
Moderate Cases
n=12 Participants
Patients diagnosed positive for COVID-19 and presenting either 3 severe symptoms or 2 severe symptoms + 2 mild symptoms. Clinical sign of viral pneumonia.
|
Severe Cases
n=20 Participants
Patient diagnosed positive for COVID-19 presenting 4 severe symptoms or 3 severe symptoms and not less than 2 mild symptoms. Clinical signs of bilateral viral pneumonia.
|
|---|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 14 daysPatients who needed dose adjustment of any of the drugs involved in the treatment protocol
Outcome measures
| Measure |
Mild Cases
n=135 Participants
Patients diagnosed positive for COVID-19 via rtPCR and presenting only mild symptoms. No clinical signs of viral pneumonia.
|
Moderate Cases
n=12 Participants
Patients diagnosed positive for COVID-19 and presenting either 3 severe symptoms or 2 severe symptoms + 2 mild symptoms. Clinical sign of viral pneumonia.
|
Severe Cases
n=20 Participants
Patient diagnosed positive for COVID-19 presenting 4 severe symptoms or 3 severe symptoms and not less than 2 mild symptoms. Clinical signs of bilateral viral pneumonia.
|
|---|---|---|---|
|
Patients Needing Drug Dose Adjustment
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 14 daysPatient presenting serious adverse events
Outcome measures
| Measure |
Mild Cases
n=135 Participants
Patients diagnosed positive for COVID-19 via rtPCR and presenting only mild symptoms. No clinical signs of viral pneumonia.
|
Moderate Cases
n=12 Participants
Patients diagnosed positive for COVID-19 and presenting either 3 severe symptoms or 2 severe symptoms + 2 mild symptoms. Clinical sign of viral pneumonia.
|
Severe Cases
n=20 Participants
Patient diagnosed positive for COVID-19 presenting 4 severe symptoms or 3 severe symptoms and not less than 2 mild symptoms. Clinical signs of bilateral viral pneumonia.
|
|---|---|---|---|
|
Adverse Events
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Mild Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Severe Cases
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Mild Cases
n=135 participants at risk
Patients diagnosed positive for COVID-19 presenting only mild symptoms and no clinical signs of viral pneumonia.
|
Moderate Cases
n=12 participants at risk
Patients diagnosed positive for COVID-19 by rtPCR presenting 3 severe symptoms or 2 severe symptoms + 2 mild symptoms or clinical signs of viral pneumonia
|
Severe Cases
n=20 participants at risk
Patients diagnosed positive for COVID-19 by rtPCR presenting 4 severe symptoms or 3 severe symptoms + 2 mild symptoms or clinical signs of bilateral viral pneumonia
|
|---|---|---|---|
|
Infections and infestations
multiple organ failure
|
0.00%
0/135 • 2 months
|
0.00%
0/12 • 2 months
|
5.0%
1/20 • Number of events 1 • 2 months
|
Other adverse events
| Measure |
Mild Cases
n=135 participants at risk
Patients diagnosed positive for COVID-19 presenting only mild symptoms and no clinical signs of viral pneumonia.
|
Moderate Cases
n=12 participants at risk
Patients diagnosed positive for COVID-19 by rtPCR presenting 3 severe symptoms or 2 severe symptoms + 2 mild symptoms or clinical signs of viral pneumonia
|
Severe Cases
n=20 participants at risk
Patients diagnosed positive for COVID-19 by rtPCR presenting 4 severe symptoms or 3 severe symptoms + 2 mild symptoms or clinical signs of bilateral viral pneumonia
|
|---|---|---|---|
|
Gastrointestinal disorders
Hemorrhage
|
0.00%
0/135 • 2 months
|
0.00%
0/12 • 2 months
|
5.0%
1/20 • Number of events 1 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place