A Phase 3 interventional study of Ivermectin in COVID-19, sponsored by Afyonkarahisar Health Sciences University. Completed at 4 sites in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Afyonkarahisar Health Sciences University · Phase 3, Interventional, and Treatment
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.
Patients with severe COVID-19 pneumonia were included in the study. Two groups, the study group and the control group, took part in the study.
Ivermectin 200 mcg/kg/day for five days (9 mg between 36-50 kg, 12 mg between 51-65 kg, 15 mg between 66-79 kg and 200 microgram/kg in > 80 kg) in the form of a solution prepared for enteral use added to the reference treatment protocol -hydroxychloroquine (2x400mg loading dose followed by 2x200mg, po, 5 days) + favipiravir (2x1600mg loading dose followed by 2x600mg maintenance dose, po, total 5 days) + azithromycin (first day 500mg followed by 4 days 250mg/day, po, total 5 days)- of patients included in the study group. Patients in the control group were given only reference treatment with 3 other drugs without ivermectin.
The mutations in 29 pairs of primers in mdr1/abcab1 gene by sequencing analysis using Sanger method, and the haplotypes and mutations of the CYP3A4 gene that cause the function losing were investigated among the patients who meet criteria and who were included in the study group according to randomization. Mutation screening was done when the first dose of the research drug ivermectin was given, ivermectin treatment was not continued in patients with mutations detected as a result of genetic examination and these patients were excluded from the study.
Patients were followed for 5 additional days after treatment. At the end of the treatment and follow-up period (At the end of 10th day), clinical response and changes in oxygenation and laboratory parameters were evaluated.
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Patients with at least one of the criteria below were accepted as patients with severe COVID-19 pneumonia;
Exclusion Criteria:
Patients with the following characteristics were excluded from the study.
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 control and study group, respectively. Hydroxychloroquine, favipiravir and azithromycin (HFA) standard treatment protocol were given to the control group as recommended in the "COVID-19 (SARS-CoV-2 Infection) Guide" prepared by the Republic of Turkey Ministry of Health.
In addition to HFA treatment, ivermectin 200 micrograms/kg/day (9mg between 36-50 kg, 12mg between 51-65 kg, 15mg between 66-79 kg and 200 micrograms/kg in \> 80 kg) in the form of a solution prepared for enteral use was added (HFA+I) to the treatment protocol of the study group's for five days. Blood sample was taken with the first dose of ivermectin and haplotype analysis was performed in ABCB1 and CYP3A4 genes in the whole study group.
Drug: Ivermectin
Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under "Good Manufacturing Practices" (GMP) certification conditions.
Also known as: Hydroxychloroquine, favipiravir and azithromycin
Gender Distribution of the Patients
The gender of patients (Male/female) in both groups were recorded at the time of inclusion.
Time frame: At the first day of the study
Age Distribution of the Patients
The age of the patients (years) in both groups were recorded at the time of inclusion.
Time frame: At the first day of the study
Percentage of Patients With Accompanying Diseases
At the beginning of the study, the patients were asked whether there were any of the following accompanying diseases and the percentage of patients with accompanying disease in both groups were recorded: * Diabetes mellitus * Hypertension * Coronary artery disease * Cardiac failure * Chronic obstructive pulmonary disease * Malignancy * Immunodeficiency
Time frame: At the first day of the study
Percentage of Patients With Baseline Clinical Symptoms
At the beginning of the study, the patients were asked whether there were any of the following clinical symptoms and the percentage of patients with any of the clinical symptoms in both groups were recorded: * Fever * Cough * Sore throat * Dispnea * Headache * Weakness * Myalgia * Diarrhea * Nausea or vomiting
Time frame: At the first day of the study
Body Temperature Means of the Patients
At the beginning of the study, the body temperatures (as degree celcius) of the patients were measured and the mean body temperature values of both groups were recorded.
Time frame: At the first day of the study
Heart Rate Means of the Patients
At the beginning of the study, the heart rates (as per minute) of the patients were measured and the mean heart rate values of both groups were recorded.
Time frame: At the first day of the study
Respiratory Rate Means of the Patients
At the beginning of the study, the respiratory rates (as per minute) of the patients were measured and the mean respiratory rate values of both groups were recorded.
Time frame: At the first day of the study
Systolic and Diastolic Pressure Means of the Patients
At the beginning of the study, the systolic and diastolic pressures (as mmHg) of the patients were measured and the mean systolic and diastolic pressure values of both groups were recorded.
Time frame: At the first day of the study
Number of Participants With Clinical Response
The presence of at least two of the following criteria in patients at the end of 5th day were accepted as "clinical response": Extubation in mechanically ventilated patients, respiratory rate \<26/min, SpO2 level in room air \>90%, PaO2/FiO2 \>300 in patients receiving oxygen, presence of at least two of the 2-point reduction criteria in "Sequential Organ Failure Assessment (SOFA)" score.
Time frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)
Changes in Oxygen Saturation (SpO2) Values
Baseline SpO2 values of the patients were recorded in both groups. Then, their treatments were started and SpO2 values at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in SpO2 values on the 1st, 3rd and 5th days after the basal value calculated graphically, the change in the SpO2 value at the end of the 5th day (primary endpoint) with the baseline value was compared statistically (the results were given as p value).
Time frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)
Changes in the Ratio of Partial Pressure of Oxygen (PaO2) to Fraction of Inspired Oxygen (FiO2) (PaO2/FiO2)
Baseline PaO2/FiO2 ratios of the patients were recorded in both groups. Then, their treatments were started and PaO2/FiO2 ratios at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in PaO2/FiO2 ratios on the 1st, 3rd and 5th days after the basal ratio was calculated graphically, the change in the PaO2/FiO2 ratio at the end of the 5th day (primary endpoint) with the baseline value was compared statistically (the results were given as p value).
Time frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)
Changes in Serum Lymphocyte Counts
Baseline Serum Lymphocyte counts (cell/mm\^3) of the patients were recorded in both groups. Then, their treatments were started and Serum Lymphocyte counts at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in Serum Lymphocyte counts on the 1st, 3rd and 5th days after the basal level was calculated graphically, the change in the Serum Lymphocyte count at the end of the 5th day (primary endpoint) with the baseline count was compared statistically (the results were given as p value).
Time frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)
Changes in the Ratio of Polymorphonuclear Leukocyte Count to Lymphocyte Count (PNL/L)
Baseline PNL/L ratio of the patients were recorded in both groups. Then, their treatments were started and PNL/L ratios at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in PNL/L ratios on the 1st, 3rd and 5th days after the basal level was calculated graphically, the change in the PNL/L ratio at the end of the 5th day (primary endpoint) with the baseline ratio was compared statistically (the results were given as p value).
Time frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)
Changes in Serum Ferritin Levels
Baseline serum ferritin levels (mg/dL) of the patients were recorded in both groups. Then, their treatments were started and serum ferritin levels at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in serum ferritin levels on the 1st, 3rd and 5th days after the basal level was calculated graphically, the change in the serum ferritin level at the end of the 5th day (primary endpoint) with the baseline level was compared statistically (the results were given as p value).
Time frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)
Changes in Serum D-dimer Levels
Baseline serum D-dimer levels (mg/L) of the patients were recorded in both groups. Then, their treatments were started and serum D-dimer levels at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in serum D-dimer levels on the 1st, 3rd and 5th days after the basal level was calculated graphically, the change in the serum D-dimer level at the end of the 5th day (primary endpoint) with the baseline level was compared statistically (the results were given as p value).
Time frame: From starting to the end of ivermectin therapy (0 to the end of 5th day)
Genetic Examination of Haplotypes and Mutations That Cause Function Losing for Ivermectin Metabolism
A blood sample was taken from the patients included in the study group, after taking or during the first dose of ivermectin. From the blood samples, haplotypes and mutations that cause the function losing were investigated by performing sequence analysis of multidrug resistance 1 (MDR1)/ABCB1 and CYP3A4 genes with Sanger method. In case of detection of mutation, the patient were excluded from the study and if observed, side effects of ivermectin were noted.
Time frame: At the first day of ivermectin therapy (1st day)
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Adverse effects of ivermectin and drugs other than ivermectin (Hydroxychloroquine, favipiravir, azithromycin) were evaluated in the patients in the study group and and the number of participants were noted. Adverse effects of drugs other than ivermectin (Hydroxychloroquine, favipiravir, azithromycin) were evaluated in the patients in the control group and and the number of participants were noted.
Time frame: At the first 5 days of study
Number of Participants With Clinical Response
The presence of at least two of the following criteria in patients on the 10th day were accepted as "clinical response": Respiration rate between 22-24/min, SpO2 level in room air \>95%, absence of oxygen requirement, observation of radiological improvement in control lung tomography and no need for intensive care.
Time frame: 10 days (5 days ivermectin therapy plus 5 days follow-up)
Mortality
The number of died patients were evaluated in study and control groups
Time frame: Through study completion, an average of 3 months
Changes in Oxygen Saturation (SpO2) Values
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). SpO2 values at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in SpO2 values on the 6th, 8th and 10th days was calculated graphically, the change in the SpO2 value at the end of the 10th day (secondary endpoint) with the baseline value was compared statistically (the results were given as p value).
Time frame: From 6th to the end of 10th day
Changes in the Ratio of Partial Pressure of Oxygen (PaO2) to Fraction of Inspired Oxygen (FiO2) (PaO2/FiO2)
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). PaO2/FiO2 ratios at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in PaO2/FiO2 ratios on the 6th, 8th and 10th days was calculated graphically, the change in the PaO2/FiO2 ratio at the end of the 10th day (secondary endpoint) with the baseline ratio was compared statistically (the results were given as p value).
Time frame: From 6th to the end of 10th day
Changes in Serum Lymphocyte Counts
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). Serum lymphocyte counts (cell/mm\^3) at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in serum lymphocyte counts on the 6th, 8th and 10th days was calculated graphically, the change in the serum lymphocyte count at the end of the 10th day (secondary endpoint) with the baseline value was compared statistically (the results were given as p value).
Time frame: From 6th to the end of 10th day
Changes in the Ratio of Polymorphonuclear Leukocyte Count to Lymphocyte Count (PNL/L)
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). PNL/L ratios at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in PNL/L ratios on the 6th, 8th and 10th days was calculated graphically, the change in the PNL/L ratio at the end of the 10th day (secondary endpoint) with the baseline value was compared statistically (the results were given as p value).
Time frame: From 6th to the end of 10th day
Changes in Serum Ferritin Levels
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). Serum ferritin levels (mg/dL) at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in serum ferritin levels on the 6th, 8th and 10th days was calculated graphically, the change in the serum ferritin level at the end of the 10th day (secondary endpoint) with the baseline value was compared statistically (the results were given as p value).
Time frame: From 6th to the end of 10th day
Changes in Serum D-dimer Levels
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). Serum D-dimer levels (mg/L) at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in Serum D-dimer levels on the 6th, 8th and 10th days was calculated graphically, the change in the serum D-dimer level at the end of the 10th day (secondary endpoint) with the baseline value was compared statistically (the results were given as p value).
Time frame: From 6th to the end of 10th day
Rate of COVID-19 Polymerase Chain Reaction (PCR) Test Negativity
At the end of the follow-up period (10th day), patients in the study and control group were investigated by PCR test for SARS-CoV-2 and the negative results were recorded as percentage for both groups.
Time frame: At the end of 10th day
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Adverse effects of ivermectin and drugs other than ivermectin (Hydroxychloroquine, favipiravir, azithromycin) were evaluated in the patients in the study group and and the number of participants were noted. Adverse effects of drugs other than ivermectin (Hydroxychloroquine, favipiravir, azithromycin) were evaluated in the patients in the control group and and the number of participants were noted.
Time frame: From the 6th day of study to the 10th day of study
| Milestone | Control Group | Study Group |
|---|---|---|
| Started | 30 | 36 |
| Completed | 30 | 30 |
| Not completed | 0 | 6 |
| Withdrew: Mutation disrupting ivermectin metabolism was found in 6 patients | 0 | 6 |
The gender of patients (Male/female) in both groups were recorded at the time of inclusion.
| Participants | Control Group | Study Group |
|---|---|---|
| Male | 19 | 21 |
| Female | 11 | 9 |
The age of the patients (years) in both groups were recorded at the time of inclusion.
| Years | Control Group | Study Group |
|---|---|---|
| Age Distribution of the Patients | 66.23 ± 13.31 | 58.17 ± 11.52 |
At the beginning of the study, the patients were asked whether there were any of the following accompanying diseases and the percentage of patients with accompanying disease in both groups were recorded: * Diabetes mellitus * Hypertension * Coronary artery disease * Cardiac failure * Chronic obstructive pulmonary disease * Malignancy * Immunodeficiency
| Participants | Control Group | Study Group |
|---|---|---|
| Diabetes Mellitus | 10 | 9 |
| Hypertension | 12 | 15 |
| Coronary artery disease | 8 | 5 |
| Cardiac failure | 1 | 0 |
| Chronic obstructive pulmonary disease | 3 | 6 |
| Malignancy | 1 | 0 |
| Immunodeficiency | 1 | 0 |
At the beginning of the study, the patients were asked whether there were any of the following clinical symptoms and the percentage of patients with any of the clinical symptoms in both groups were recorded: * Fever * Cough * Sore throat * Dispnea * Headache * Weakness * Myalgia * Diarrhea * Nausea or vomiting
| Participants | Control Group | Study Group |
|---|---|---|
| Fever | 13 | 15 |
| Cough | 14 | 16 |
| Sore throat | 1 | 3 |
| dyspnea | 19 | 23 |
| Headache | 2 | 5 |
| Weakness | 11 | 13 |
| Myalgia | 7 | 9 |
| Diarrhea | 0 | 1 |
| Nausea or vomiting | 0 | 1 |
At the beginning of the study, the body temperatures (as degree celcius) of the patients were measured and the mean body temperature values of both groups were recorded.
| Degree celcius | Control Group | Study Group |
|---|---|---|
| Body Temperature Means of the Patients | 36.8 ± 0.8 | 36.9 ± 0.7 |
At the beginning of the study, the heart rates (as per minute) of the patients were measured and the mean heart rate values of both groups were recorded.
| beats per minute | Control Group | Study Group |
|---|---|---|
| Heart Rate Means of the Patients | 92 ± 18 | 88 ± 12 |
At the beginning of the study, the respiratory rates (as per minute) of the patients were measured and the mean respiratory rate values of both groups were recorded.
| breaths per minute | Control Group | Study Group |
|---|---|---|
| Respiratory Rate Means of the Patients | 24.7 ± 0.7 | 24 ± 5 |
At the beginning of the study, the systolic and diastolic pressures (as mmHg) of the patients were measured and the mean systolic and diastolic pressure values of both groups were recorded.
| mmHg | Control Group | Study Group |
|---|---|---|
| Systolic pressure | 124.61 ± 15.37 | 124.39 ± 15.60 |
| Diastolic pressure | 73.43 ± 8.47 | 75.64 ± 9.79 |
The presence of at least two of the following criteria in patients at the end of 5th day were accepted as "clinical response": Extubation in mechanically ventilated patients, respiratory rate \<26/min, SpO2 level in room air \>90%, PaO2/FiO2 \>300 in patients receiving oxygen, presence of at least two of the 2-point reduction criteria in "Sequential Organ Failure Assessment (SOFA)" score.
| Participants | Control Group | Study Group |
|---|---|---|
| Number of Participants With Clinical Response | 11 | 14 |
Baseline SpO2 values of the patients were recorded in both groups. Then, their treatments were started and SpO2 values at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in SpO2 values on the 1st, 3rd and 5th days after the basal value calculated graphically, the change in the SpO2 value at the end of the 5th day (primary endpoint) with the baseline value was compared statistically (the results were given as p value).
| percentage of peripheral capillary O2 | Control Group | Study Group |
|---|---|---|
| Baseline | 89.67 ± 5.09 | 89.93 ± 6.51 |
| TD1 | 90.50 ± 7.47 | 92.85 ± 4.86 |
| TD3 | 91.90 ± 4.97 | 93.07 ± 4.12 |
| TD5 | 93.00 ± 3.25 | 93.52 ± 4.36 |
Baseline PaO2/FiO2 ratios of the patients were recorded in both groups. Then, their treatments were started and PaO2/FiO2 ratios at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in PaO2/FiO2 ratios on the 1st, 3rd and 5th days after the basal ratio was calculated graphically, the change in the PaO2/FiO2 ratio at the end of the 5th day (primary endpoint) with the baseline value was compared statistically (the results were given as p value).
| Ratio | Control Group | Study Group |
|---|---|---|
| Baseline | 197.44 ± 102.31 | 158.83 ± 88.15 |
| TD1 | 181.83 ± 99.62 | 147.31 ± 74.15 |
| TD3 | 174.77 ± 94.74 | 147.74 ± 83.30 |
| TD5 | 180.13 ± 95.43 | 178.94 ± 98.21 |
Baseline Serum Lymphocyte counts (cell/mm\^3) of the patients were recorded in both groups. Then, their treatments were started and Serum Lymphocyte counts at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in Serum Lymphocyte counts on the 1st, 3rd and 5th days after the basal level was calculated graphically, the change in the Serum Lymphocyte count at the end of the 5th day (primary endpoint) with the baseline count was compared statistically (the results were given as p value).
| cell/mm^3 | Control Group | Study Group |
|---|---|---|
| Baseline | 1010 ± 438 | 932 ± 483 |
| TD1 | 1034 ± 450 | 928 ± 607 |
| TD3 | 977 ± 575 | 1021 ± 648 |
| TD5 | 968 ± 477 | 1273 ± 822 |
Baseline PNL/L ratio of the patients were recorded in both groups. Then, their treatments were started and PNL/L ratios at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in PNL/L ratios on the 1st, 3rd and 5th days after the basal level was calculated graphically, the change in the PNL/L ratio at the end of the 5th day (primary endpoint) with the baseline ratio was compared statistically (the results were given as p value).
| Ratio | Control Group | Study Group |
|---|---|---|
| Baseline | 7.48 ± 6.41 | 8.77 ± 8.35 |
| TD1 | 7.74 ± 7.47 | 10.82 ± 8.55 |
| TD3 | 9.26 ± 7.58 | 9.02 ± 13.08 |
| TD5 | 9.88 ± 8.45 | 7.16 ± 4.97 |
Baseline serum ferritin levels (mg/dL) of the patients were recorded in both groups. Then, their treatments were started and serum ferritin levels at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in serum ferritin levels on the 1st, 3rd and 5th days after the basal level was calculated graphically, the change in the serum ferritin level at the end of the 5th day (primary endpoint) with the baseline level was compared statistically (the results were given as p value).
| mg/dL | Control Group | Study Group |
|---|---|---|
| Baseline | 747.05 ± 800.54 | 682.75 ± 470.08 |
| TD1 | 783.03 ± 827.10 | 834.94 ± 624.12 |
| TD3 | 881.17 ± 779.95 | 875.90 ± 694.52 |
| TD5 | 1028.24 ± 777.08 | 875.12 ± 1193.06 |
Baseline serum D-dimer levels (mg/L) of the patients were recorded in both groups. Then, their treatments were started and serum D-dimer levels at the end of the 1st (TD1), 3rd (TD3) and 5th days (TD5) were also recorded. The end of the 5th day was accepted as the primary endpoint. While the change in serum D-dimer levels on the 1st, 3rd and 5th days after the basal level was calculated graphically, the change in the serum D-dimer level at the end of the 5th day (primary endpoint) with the baseline level was compared statistically (the results were given as p value).
| mg/L | Control Group | Study Group |
|---|---|---|
| Baseline | 1.32 ± 2.04 | 1.25 ± 1.71 |
| TD1 | 2.80 ± 5.66 | 1.40 ± 1.73 |
| TD3 | 4.14 ± 9.91 | 3.24 ± 11.60 |
| TD5 | 3.58 ± 8.27 | 5.85 ± 5.28 |
A blood sample was taken from the patients included in the study group, after taking or during the first dose of ivermectin. From the blood samples, haplotypes and mutations that cause the function losing were investigated by performing sequence analysis of multidrug resistance 1 (MDR1)/ABCB1 and CYP3A4 genes with Sanger method. In case of detection of mutation, the patient were excluded from the study and if observed, side effects of ivermectin were noted.
| Participants | Control Group | Study Group |
|---|---|---|
| Mutation positive | 0 | 6 |
| Mutation negative | 0 | 30 |
Adverse effects of ivermectin and drugs other than ivermectin (Hydroxychloroquine, favipiravir, azithromycin) were evaluated in the patients in the study group and and the number of participants were noted. Adverse effects of drugs other than ivermectin (Hydroxychloroquine, favipiravir, azithromycin) were evaluated in the patients in the control group and and the number of participants were noted.
| Participants | Control Group | Study Group |
|---|---|---|
| Nausea and vomiting | 2 | 0 |
| Increase in liver function tests | 1 | 0 |
The presence of at least two of the following criteria in patients on the 10th day were accepted as "clinical response": Respiration rate between 22-24/min, SpO2 level in room air \>95%, absence of oxygen requirement, observation of radiological improvement in control lung tomography and no need for intensive care.
| Participants | Control Group | Study Group |
|---|---|---|
| Number of Participants With Clinical Response | 16 | 22 |
The number of died patients were evaluated in study and control groups
| Participants | Control Group | Study Group |
|---|---|---|
| Mortality | 9 | 6 |
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). SpO2 values at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in SpO2 values on the 6th, 8th and 10th days was calculated graphically, the change in the SpO2 value at the end of the 10th day (secondary endpoint) with the baseline value was compared statistically (the results were given as p value).
| percentage of peripheral capillary O2 | Control Group | Study Group |
|---|---|---|
| Baseline | 89.67 ± 5.09 | 89.93 ± 6.51 |
| FD1 | 92.43 ± 2.86 | 94.54 ± 2.21 |
| FD3 | 92.91 ± 2.71 | 94.24 ± 2.76 |
| FD5 | 93.00 ± 3.93 | 95.35 ± 2.72 |
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). PaO2/FiO2 ratios at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in PaO2/FiO2 ratios on the 6th, 8th and 10th days was calculated graphically, the change in the PaO2/FiO2 ratio at the end of the 10th day (secondary endpoint) with the baseline ratio was compared statistically (the results were given as p value).
| Ratio | Control Group | Study Group |
|---|---|---|
| Baseline | 197.44 ± 102.31 | 158.83 ± 88.15 |
| FD1 | 204.28 ± 109.51 | 199.83 ± 85.02 |
| FD3 | 211.75 ± 127.62 | 227.43 ± 103.71 |
| FD5 | 220.78 ± 127.26 | 236.33 ± 85.66 |
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). Serum lymphocyte counts (cell/mm\^3) at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in serum lymphocyte counts on the 6th, 8th and 10th days was calculated graphically, the change in the serum lymphocyte count at the end of the 10th day (secondary endpoint) with the baseline value was compared statistically (the results were given as p value).
| cell/mm^3 | Control Group | Study Group |
|---|---|---|
| Baseline | 1010 ± 438 | 932 ± 483 |
| FD1 | 916 ± 411 | 1403 ± 869 |
| FD3 | 1086 ± 880 | 1668 ± 819 |
| FD5 | 1256 ± 710 | 1698 ± 1438 |
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). PNL/L ratios at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in PNL/L ratios on the 6th, 8th and 10th days was calculated graphically, the change in the PNL/L ratio at the end of the 10th day (secondary endpoint) with the baseline value was compared statistically (the results were given as p value).
| Ratio | Control Group | Study Group |
|---|---|---|
| Baseline | 7.48 ± 6.41 | 8.77 ± 8.35 |
| FD1 | 10.49 ± 7.10 | 6.90 ± 11.84 |
| FD3 | 9.66 ± 10.99 | 5.81 ± 9.99 |
| FD5 | 6.19 ± 4.85 | 7.34 ± 8.09 |
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). Serum ferritin levels (mg/dL) at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in serum ferritin levels on the 6th, 8th and 10th days was calculated graphically, the change in the serum ferritin level at the end of the 10th day (secondary endpoint) with the baseline value was compared statistically (the results were given as p value).
| mg/dL | Control Group | Study Group |
|---|---|---|
| Baseline | 747.05 ± 800.54 | 682.75 ± 470.08 |
| FD1 | 1076.88 ± 704.05 | 628.45 ± 580.10 |
| FD3 | 1097.57 ± 595.22 | 433.48 ± 641.82 |
| FD5 | 1206.90 ± 782.84 | 494.71 ± 349.78 |
In both groups, after the treatment period was completed (first 5 days, primary endpoint), patients were followed up for 5 more days (follow-up period). Serum D-dimer levels (mg/L) at the end of 6th (FD1), 8th (FD3) and 10th day (FD5) were also recorded. The end of the 10th day was accepted as the secondary endpoint. While the change in Serum D-dimer levels on the 6th, 8th and 10th days was calculated graphically, the change in the serum D-dimer level at the end of the 10th day (secondary endpoint) with the baseline value was compared statistically (the results were given as p value).
| mg/L | Control Group | Study Group |
|---|---|---|
| Baseline | 1.32 ± 2.04 | 1.25 ± 1.71 |
| FD1 | 3.45 ± 6.60 | 1.37 ± 2.53 |
| FD3 | 1.63 ± 1.38 | 0.89 ± 2.45 |
| FD5 | 1.49 ± 2.28 | 0.71 ± 0.96 |
At the end of the follow-up period (10th day), patients in the study and control group were investigated by PCR test for SARS-CoV-2 and the negative results were recorded as percentage for both groups.
| Participants | Control Group | Study Group |
|---|---|---|
| Rate of COVID-19 Polymerase Chain Reaction (PCR) Test Negativity | 3 | 14 |
Adverse effects of ivermectin and drugs other than ivermectin (Hydroxychloroquine, favipiravir, azithromycin) were evaluated in the patients in the study group and and the number of participants were noted. Adverse effects of drugs other than ivermectin (Hydroxychloroquine, favipiravir, azithromycin) were evaluated in the patients in the control group and and the number of participants were noted.
| Participants | Control Group | Study Group |
|---|---|---|
| Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 0 | 0 |
Collected over From the beginning of the study to the end of the 10th day. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 9/30 (30%) | 0/30 (0%) | 3/30 (10%) |
| Study Group | 6/30 (20%) | 0/30 (0%) | 0/30 (0%) |
| Participants With Mutations | 0/6 (0%) | 5/6 (83.3%) | 0/6 (0%) |
| Event | Control Group | Study Group | Participants With Mutations |
|---|---|---|---|
| EncephalopathyNervous system disorders | 0/30 | 0/30 | 5/6 |
| Event | Control Group | Study Group | Participants With Mutations |
|---|---|---|---|
| Nausea and vomitingGastrointestinal disorders | 2/30 | 0/30 | 0/6 |
| Increase in liver function testsGastrointestinal disorders | 1/30 | 0/30 | 0/6 |
36 patients were included in the study group. But, 6 patients in the study group were excluded from the study and analysis because ivermectin treatments were terminated due to the detection of a mutation that impairs ivermectin metabolism. As a result, overall number of baseline participants in the study group was 30.
| Age, Customized(years) | Control Group | Study Group | Total |
|---|---|---|---|
| Mean | 66.23 ± 13.31 | 58.17 ± 11.52 | 62.20 ± 13.00 |
| Sex: Female, Male(Participants) | Control Group | Study Group | Total |
|---|---|---|---|
| Female | 11 | 9 | 20 |
| Male | 19 | 21 | 40 |
| Race (NIH/OMB)(Participants) | Control Group | Study Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 30 | 30 | 60 |
| Region of Enrollment(participants) | Control Group | Study Group | Total |
|---|---|---|---|
| Turkey | 30 | 30 | 60 |
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Afyonkarahisar Health Sciences University