https://clinicaltrials.gov/ct2/show/results/NCT04646109
例如血氧饱和度，实验组显著高于对照组：
20.Secondary Outcome
| Title | Changes in Oxygen Saturation (SpO2) Values |
|---|---|
 Description |
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 |
Outcome Measure Data Analysis Population Description[Not Specified]
| Arm/Group Title | Control Group | Study Group |
|---|---|---|
| Arm/Group Description: |
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. Ivermectin: Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under "Good Manufacturing Practices" (GMP) certification conditions. |
| Overall Number of Participants Analyzed | 30 | 30 |
| Mean (Standard Deviation)
Unit of Measure: percentage of peripheral capillary O2
|
||
| 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) |
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Control Group, Study Group |
|---|---|---|
| Comments | [Not Specified] | |
| Type of Statistical Test | Superiority | |
| Comments | [Not Specified] | |
| Statistical Test of Hypothesis | P-Value | 0.03 |
| Comments | A p<0.05 value was considered statistically significant | |
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | [Not Specified] | |
