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Study of the efficacy and safety of the new drug "Efesovir" in comparison with the drug "Remdesivir" in the treatment of patients hospitalized with COVID-19.
The hypothesis of clinical study is the clinical efficacy of new drug "Efesovir" is 10% to 30% higher than of "Remdesivir".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efesovir | Experimental | The patients of experimental arm take study drug Efesovir twice a day as an antiviral therapy in dose 0.125 ml / kg. Daily dose of Efesovir: 0.250 ml / kg. Duration of treatment is 5 - 10 days, depending on the severity of the disease. |
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| Remdesivir | Active Comparator | The patients are treated with the antiviral drug "Remdesivir" in dose 200 mg intravenously on the 1st day, then by 100 mg intravenously daily for 5 - 10 days, depending on the severity of the disease. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efesovir | Drug | Antiviral therapy of COVID19 with Efesovir oral solution in dose 0.125 ml / kg two times per day. Duration of treatment is 5 - 10 days, depending on the severity of the disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate | Clinical Response Rate is calculated as the number of trial subjects with effective treatment over the total number of subjects multiplied by 100. It is calculated in each study group. Measured in percents. The outcome is estimated among randomized subjects completed clinical study with the protocol requirements (per protocol population (PPP)). Clinical response is evaluated as effective treatment if: all signs and symptoms of COVID19 are resolved or improved with no worsening or appearance of new signs and symptoms; there is no requirement for additional antiviral of antibacterial therapy; chest roentgenograms (CT scans) are improved. The outcome is assessed in day 21 from the start of Study Drug treatment (visits 13). | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Early Clinical Response Rate | Early clinical response rate defined as complete resolution or significant improvement of at least 2 of 4 leading baseline signs and symptoms within 72 hours after the start of Study (Referent) Drug treatment. It is estimated in the Intent to Treat (ITT) population. The outcome is measured in percents. | 72 hours (3 days) of study drug treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marina Lankina, PhD | Contact | +77057064410 | m-lankina@list.ru | |
| Gulshara Akhmetova, PhD | Contact | +77085348842 | akhmetovagk@yandex.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semey Medical University | Semey | East Kazakhstan | 071407 | Kazakhstan |
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| Label | URL |
|---|---|
| Yuldasheva, G., R. Argirova and A. Ilin. "A quantum-chemical model of the inhibition HIV-1 integrase action by iodine complex compounds and lithium halogenides." Journal of AIDS and Clinical Research 6 (2015): 1-6. DOI:10.4172/2155-6113.1000465 Corpus | View source |
| Yuldasheva, G. , Zhidomirov, G. and Ilin, A. (2011) A quantum-chemical model of the inhibition mechanism of viral DNA HIV-1 replication by Iodine complexcompounds. Natural Science, 3, 573-579. doi: 10.4236/ns.2011.37080 | View source |
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all individual participant Data (IPD )that underlie results in a publication
2022
written request
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C000599496 | pharmaceutical FS-1 |
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Participants are assigned to the one of two parallel groups: 1) treated with study drug "Efesovir"; 2) treated with referent drug "Remdesivir".
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no masking, open label
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| Early Clinical Response Rate in pneumonia | The outcome is estimated in patients with pneumonia due to coronavirus infection (modified ITT population). It is defined as complete resolution or significant improvement of at least 2 of 4 main clinical symptoms of pneumonia (cough, shortness of breath, chest pain, sputum) within 72 hours after the start of Study (or Referent) Drug treatment. The outcome is measured in percents. The percentage of subjects with an early clinical response to pneumonia in the compared groups is statistically estimated. | 72 hours (3 days) of study drug treatment |
| Percentage of clinically stable patients | Percentage of patients at Day 3 who are clinically stable. Clinical stability defined as:
| 72 hours (3 days) of study drug treatment |
| Survival rate | Percentage of participants surviving at day 21. The indicator is calculated as the number of live subjects at the last visit (day 21) divided by the total number of study subjects in the group multiplied by 100. The outcome is estimated among subjects who completed the study in compliance with the protocol (per protocol population (PPP)). | 21 days |
| Clinical Status Change | The clinical status is determined by the ordinal scale:
Clinical status is assessed in ITT population. The outcome is recorded at all visits, starting from the day of randomization. A decrease in points indicates the effectiveness of treatment. When the indicator changes during the day, the worst score of the day is recorded. Statistical analysis is performed on the Day 7 from the start Study Drug treatment, comparing with the score at randomization. | 7 days |
| Adverse Events (AE) | The safety of Study Drug (Referent Drug) will be assessed by adverse event and serious adverse event monitoring. | up to 21 days |
| Thyroid gland function | Changes in laboratory parameters of thyroid gland function (hormones) at the last visit in comparison with the baseline data (thyroid stimulating hormone (TSH), free triiodothyronine (FT3)). | Day 21 |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |