Phase 3
N=66
Ivermectin for Severe COVID-19 Management
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04646109 ↗Enrolled (actual)
66
Serious AEs
7.6%
Results posted
Jan 2021
Primary outcome: Primary: Gender Distribution of the Patients — 19; 21; 11; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ivermectin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Afyonkarahisar Health Sciences University
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gender Distribution of the Patients |
19; 21; 11; 9 | — |
| PRIMARY Age Distribution of the Patients |
66.23; 58.17 | — |
| PRIMARY Percentage of Patients With Accompanying Diseases |
10; 9; 12; 15; 8; 5 | — |
| PRIMARY Percentage of Patients With Baseline Clinical Symptoms |
13; 15; 14; 16; 1; 3 | — |
| PRIMARY Body Temperature Means of the Patients |
36.8; 36.9 | — |
| PRIMARY Heart Rate Means of the Patients |
92; 88 | — |
| PRIMARY Respiratory Rate Means of the Patients |
24.7; 24 | — |
| PRIMARY Systolic and Diastolic Pressure Means of the Patients |
124.61; 124.39; 73.43; 75.64 | — |
| PRIMARY Number of Participants With Clinical Response |
16; 22 | 0.10 |
| PRIMARY Changes in Oxygen Saturation (SpO2) Values |
89.67; 89.93; 92.43; 94.54; 92.91; 94.24 | 0.03 sig |
| PRIMARY Changes in the Ratio of Partial Pressure of Oxygen (PaO2) to Fraction of Inspired Oxygen (FiO2) (PaO2/FiO2) |
197.44; 158.83; 204.28; 199.83; 211.75; 227.43 | 0.39 |
| PRIMARY Changes in Serum Lymphocyte Counts |
1010; 932; 916; 1403; 1086; 1668 | 0.24 |
| PRIMARY Changes in the Ratio of Polymorphonuclear Leukocyte Count to Lymphocyte Count (PNL/L) |
7.48; 8.77; 10.49; 6.90; 9.66; 5.81 | 0.56 |
| PRIMARY Changes in Serum Ferritin Levels |
747.05; 682.75; 1076.88; 628.45; 1097.57; 433.48 | 0.005 sig |
| PRIMARY Changes in Serum D-dimer Levels |
1.32; 1.25; 3.45; 1.37; 1.63; 0.89 | 0.03 sig |
| PRIMARY Genetic Examination of Haplotypes and Mutations That Cause Function Losing for Ivermectin Metabolism |
0; 6; 0; 30 | — |
| PRIMARY Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |
0; 0 | — |
| SECONDARY Number of Participants With Clinical Response |
16; 22 | 0.10 |
| SECONDARY Mortality |
9; 6 | 0.37 |
| SECONDARY Changes in Oxygen Saturation (SpO2) Values |
89.67; 89.93; 92.43; 94.54; 92.91; 94.24 | 0.03 sig |
| SECONDARY Changes in the Ratio of Partial Pressure of Oxygen (PaO2) to Fraction of Inspired Oxygen (FiO2) (PaO2/FiO2) |
197.44; 158.83; 204.28; 199.83; 211.75; 227.43 | 0.39 |
| SECONDARY Changes in Serum Lymphocyte Counts |
1010; 932; 916; 1403; 1086; 1668 | 0.24 |
| SECONDARY Changes in the Ratio of Polymorphonuclear Leukocyte Count to Lymphocyte Count (PNL/L) |
7.48; 8.77; 10.49; 6.90; 9.66; 5.81 | 0.56 |
| SECONDARY Changes in Serum Ferritin Levels |
747.05; 682.75; 1076.88; 628.45; 1097.57; 433.48 | 0.005 sig |
| SECONDARY Changes in Serum D-dimer Levels |
1.32; 1.25; 3.45; 1.37; 1.63; 0.89 | 0.03 sig |
| SECONDARY Rate of COVID-19 Polymerase Chain Reaction (PCR) Test Negativity |
3; 14 | 0.01 sig |
| SECONDARY Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |
0; 0 | — |
Summary
In this multicenter study; it was aimed to investigate the effectiveness and safety of ivermectin use in the treatment of patients with severe COVID-19 pneumonia that have no mutations which alter ivermectin metabolism and cause side effects.
Eligibility Criteria
Inclusion Criteria
- Patients who were hospitalised with a pre-diagnosis of "severe COVID-19 pneumonia" and thereafter diagnosis of COVID-19 was also confirmed microbiologically with PCR positivity in respiratory tract samples were included into the study. They were randomized to the study and control group, respectively.
Patients with at least one of the criteria below were accepted as patients with severe COVID-19 pneumonia;
- Presence of tachypnea ≥ 30/minute, SpO2 level 2
Exclusion Criteria
- Patients with the following characteristics were excluded from the study.
- Pediatric patients; <18 years of old
- Patients with chronic liver or kidney disease
- Pregnant women
- Patients with known ivermectin allergy
Data sourced from ClinicalTrials.gov (NCT04646109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.