The effect of etiopathogenetic therapy of COVID-19 on the severity of the disease: results of a multicenter double-blind placebo-controlled randomized trial
Aim. The search for etiopathogenetic agents to prevent the development of severe and extremely severe COVID-19 remains relevant. A placebo-controlled randomized clinical trial was conducted to evaluate the efficacy and safety of the antibody-based biological drug (Raphamin). Materials and methods. 7...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | Russian |
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"Consilium Medicum" Publishing house
2023-12-01
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| Series: | Терапевтический архив |
| Subjects: | |
| Online Access: | https://ter-arkhiv.ru/0040-3660/article/viewFile/623522/139238 |
| _version_ | 1797376557699825664 |
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| author | Vladimir V. Nikiforov Vladimir A. Petrov Anatoly A. Stremoukhov Marina G. Avdeeva Yury G. Shvarts Irina E. Kravchenko Irina V. Nikolaeva Svetlana E. Ushakova Oksana N. Belousova Natal'ia A. Eremina Svetlana V. Teplykh Ekaterina V. Mel'nikova Natal'ia E. Kostinа |
| author_facet | Vladimir V. Nikiforov Vladimir A. Petrov Anatoly A. Stremoukhov Marina G. Avdeeva Yury G. Shvarts Irina E. Kravchenko Irina V. Nikolaeva Svetlana E. Ushakova Oksana N. Belousova Natal'ia A. Eremina Svetlana V. Teplykh Ekaterina V. Mel'nikova Natal'ia E. Kostinа |
| author_sort | Vladimir V. Nikiforov |
| collection | DOAJ |
| description | Aim. The search for etiopathogenetic agents to prevent the development of severe and extremely severe COVID-19 remains relevant. A placebo-controlled randomized clinical trial was conducted to evaluate the efficacy and safety of the antibody-based biological drug (Raphamin).
Materials and methods. 785 outpatients 18–75 y.o. with laboratory confirmed mild COVID-19 were included within 24 hours from the disease onset. 771 patients were randomized to the group Raphamin (n=382) and the Placebo group (n=389). The study drug/placebo was prescribed for 5 days. The rate of progression to a more severe degree of COVID-19 by day 28 as well as the time to sustained clinical recovery and the frequency of hospitalization were evaluated. Safety was assessed taking into account adverse events, vital signs and laboratory parameters.
Results. The number of cases of progression to a more severe degree of COVID-19 in participants receiving Raphamin was 59 (15.5%) [52 (14.6%)] versus placebo – 89 (22.9%) [85 (23.7%)], ITT and [PP] analysis data are presented. The odds ratio between groups was OR=0.6157 [OR=0.5494], 95% confidence interval 0.4276–0.8866 [0.3750–0.8048], which meant a reduction in the chance of progression to a more severe degree by 38.4% [45.1%] or 1.48 [1.62] times; p=0.0088 [p=0.0019]. The time to sustained recovery in the Raphamin group was 4.5±2.4 [4.6±2.4] days, versus placebo – 5.8±4.7 [6.0±4.8] days; p=0.0025 [p=0.0036]. No adverse events with a certain relationship were registered.
Conclusion. Raphamin reduces the risk of progression to a more severe degree of the COVID-19 and significantly shortens the duration of clinical symptoms. |
| first_indexed | 2024-03-08T19:40:18Z |
| format | Article |
| id | doaj.art-5536203adb4e4dc7874f20f741c51566 |
| institution | Directory Open Access Journal |
| issn | 0040-3660 2309-5342 |
| language | Russian |
| last_indexed | 2024-03-08T19:40:18Z |
| publishDate | 2023-12-01 |
| publisher | "Consilium Medicum" Publishing house |
| record_format | Article |
| series | Терапевтический архив |
| spelling | doaj.art-5536203adb4e4dc7874f20f741c515662023-12-25T08:46:10Zrus"Consilium Medicum" Publishing houseТерапевтический архив0040-36602309-53422023-12-01951195896410.26442/00403660.2023.11.20247978391The effect of etiopathogenetic therapy of COVID-19 on the severity of the disease: results of a multicenter double-blind placebo-controlled randomized trialVladimir V. Nikiforov0https://orcid.org/0000-0002-2205-9674Vladimir A. Petrov1https://orcid.org/0000-0002-8580-933XAnatoly A. Stremoukhov2https://orcid.org/0000-0002-4393-3543Marina G. Avdeeva3https://orcid.org/0000-0002-4979-8768Yury G. Shvarts4https://orcid.org/0000-0002-5205-7311Irina E. Kravchenko5https://orcid.org/0000-0003-4408-7542Irina V. Nikolaeva6https://orcid.org/0000-0003-0104-5895Svetlana E. Ushakova7https://orcid.org/0000-0002-8903-0948Oksana N. Belousova8https://orcid.org/0000-0001-6862-0829Natal'ia A. Eremina9https://orcid.org/0000-0002-6395-1730Svetlana V. Teplykh10https://orcid.org/0000-0003-1997-7279Ekaterina V. Mel'nikova11https://orcid.org/0000-0003-3352-5949Natal'ia E. Kostinа12https://orcid.org/0000-0002-5128-5005Pirogov Russian National Research Medical UniversityObninsk Institute for Nuclear Power Engineering – branch of National Research Nuclear University „MEPhI“Russian Medical Academy of Continuous Professional EducationKuban State Medical UniversityRazumovsky Saratov State Medical UniversityKazan State Medical UniversityKazan State Medical UniversityKuvaevs Ivanovo Clinical HospitalBelgorod State UniversityClinical Hospital RZhD Medicina„Professor clinic“ LLC„Medical center for diagnostics and prevention “ LLCVoronezh Regional Clinic Hospital №1Aim. The search for etiopathogenetic agents to prevent the development of severe and extremely severe COVID-19 remains relevant. A placebo-controlled randomized clinical trial was conducted to evaluate the efficacy and safety of the antibody-based biological drug (Raphamin). Materials and methods. 785 outpatients 18–75 y.o. with laboratory confirmed mild COVID-19 were included within 24 hours from the disease onset. 771 patients were randomized to the group Raphamin (n=382) and the Placebo group (n=389). The study drug/placebo was prescribed for 5 days. The rate of progression to a more severe degree of COVID-19 by day 28 as well as the time to sustained clinical recovery and the frequency of hospitalization were evaluated. Safety was assessed taking into account adverse events, vital signs and laboratory parameters. Results. The number of cases of progression to a more severe degree of COVID-19 in participants receiving Raphamin was 59 (15.5%) [52 (14.6%)] versus placebo – 89 (22.9%) [85 (23.7%)], ITT and [PP] analysis data are presented. The odds ratio between groups was OR=0.6157 [OR=0.5494], 95% confidence interval 0.4276–0.8866 [0.3750–0.8048], which meant a reduction in the chance of progression to a more severe degree by 38.4% [45.1%] or 1.48 [1.62] times; p=0.0088 [p=0.0019]. The time to sustained recovery in the Raphamin group was 4.5±2.4 [4.6±2.4] days, versus placebo – 5.8±4.7 [6.0±4.8] days; p=0.0025 [p=0.0036]. No adverse events with a certain relationship were registered. Conclusion. Raphamin reduces the risk of progression to a more severe degree of the COVID-19 and significantly shortens the duration of clinical symptoms.https://ter-arkhiv.ru/0040-3660/article/viewFile/623522/139238covid-19reducing severe covid-19raphaminetiopathogenetic therapy covid-19 |
| spellingShingle | Vladimir V. Nikiforov Vladimir A. Petrov Anatoly A. Stremoukhov Marina G. Avdeeva Yury G. Shvarts Irina E. Kravchenko Irina V. Nikolaeva Svetlana E. Ushakova Oksana N. Belousova Natal'ia A. Eremina Svetlana V. Teplykh Ekaterina V. Mel'nikova Natal'ia E. Kostinа The effect of etiopathogenetic therapy of COVID-19 on the severity of the disease: results of a multicenter double-blind placebo-controlled randomized trial Терапевтический архив covid-19 reducing severe covid-19 raphamin etiopathogenetic therapy covid-19 |
| title | The effect of etiopathogenetic therapy of COVID-19 on the severity of the disease: results of a multicenter double-blind placebo-controlled randomized trial |
| title_full | The effect of etiopathogenetic therapy of COVID-19 on the severity of the disease: results of a multicenter double-blind placebo-controlled randomized trial |
| title_fullStr | The effect of etiopathogenetic therapy of COVID-19 on the severity of the disease: results of a multicenter double-blind placebo-controlled randomized trial |
| title_full_unstemmed | The effect of etiopathogenetic therapy of COVID-19 on the severity of the disease: results of a multicenter double-blind placebo-controlled randomized trial |
| title_short | The effect of etiopathogenetic therapy of COVID-19 on the severity of the disease: results of a multicenter double-blind placebo-controlled randomized trial |
| title_sort | effect of etiopathogenetic therapy of covid 19 on the severity of the disease results of a multicenter double blind placebo controlled randomized trial |
| topic | covid-19 reducing severe covid-19 raphamin etiopathogenetic therapy covid-19 |
| url | https://ter-arkhiv.ru/0040-3660/article/viewFile/623522/139238 |
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