Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial
Objectives: The primary objective is to determine the effect of a daily dose of ivermectin administered in three consecutive days to non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of SARS-CoV-2 RNA by PCR from nasopharyngeal swabs at day seven post-treatment in...
| Autores: | , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2021 |
| País: | España |
| Institución: | Universidad de Navarra |
| Repositorio: | Dadun. Depósito Académico Digital de la Universidad de Navarra |
| Idioma: | inglés |
| OAI Identifier: | oai:dadun.unav.edu:10171/115300 |
| Acceso en línea: | https://hdl.handle.net/10171/115300 |
| Access Level: | acceso abierto |
| Palabra clave: | COVID-19 Randomized controlled trial Protocol SARS-CoV-2 PCR Early treatment Ivermectin Antiviral Immunomodulatory Peru |
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Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trialGarcia, P.J. (Patricia J.)|||/items/f10ef114-39fd-4e49-bc75-e5be976071b0Mundaca, H. (Hansel)|||/items/e6fce9f7-0b77-4b71-98a6-e669a8604a72Ugarte-Gil, C. (Cesar)|||/items/3db534ef-f47e-4ea7-a6d5-463d42b2b2ccLeon, P. (Patricia)|||/items/0e2474ff-17cc-4a69-80e9-75d2b3d21c07Malaga, G. (German)|||/items/01612d24-6bde-4f9b-aeae-af75873feb96Chaccour-Díaz, C.J. (Carlos Javier)|||/items/94d62c6d-ac64-42ab-b253-feb88e916983Carcamo, C.P. (Cesar P.)|||/items/a42d10ac-736d-4c23-ae12-48dd17d18e6eCOVID-19Randomized controlled trialProtocolSARS-CoV-2PCREarly treatmentIvermectinAntiviralImmunomodulatoryPeruObjectives: The primary objective is to determine the effect of a daily dose of ivermectin administered in three consecutive days to non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of SARS-CoV-2 RNA by PCR from nasopharyngeal swabs at day seven post-treatment initiation. The secondary objectives are: 1. To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab on days 4, 7, 14 and 21 post-treatment initiation 2. To assess the efficacy of ivermectin on the improvement of symptoms 3. To assess the proportion of seroconversions at day 21 4. To assess the safety of ivermectin at the proposed dose 5. To determine the magnitude of the immune response against SARS-CoV-2 6. To assess correlation of the presence of intestinal helminths on participants on baseline and day 14 with COVID-19 progression and treatment.BioMed CentralDadun. Depósito Académico Digital Universidad de Navarra20212021-01-0120212021-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/115300reponame:Dadun. Depósito Académico Digital de la Universidad de Navarrainstname:Universidad de NavarraInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:dadun.unav.edu:10171/1153002026-06-21T12:47:57Z |
| dc.title.none.fl_str_mv |
Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial |
| title |
Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial |
| spellingShingle |
Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial Garcia, P.J. (Patricia J.)|||/items/f10ef114-39fd-4e49-bc75-e5be976071b0 COVID-19 Randomized controlled trial Protocol SARS-CoV-2 PCR Early treatment Ivermectin Antiviral Immunomodulatory Peru |
| title_short |
Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial |
| title_full |
Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial |
| title_fullStr |
Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial |
| title_full_unstemmed |
Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial |
| title_sort |
Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial |
| dc.creator.none.fl_str_mv |
Garcia, P.J. (Patricia J.)|||/items/f10ef114-39fd-4e49-bc75-e5be976071b0 Mundaca, H. (Hansel)|||/items/e6fce9f7-0b77-4b71-98a6-e669a8604a72 Ugarte-Gil, C. (Cesar)|||/items/3db534ef-f47e-4ea7-a6d5-463d42b2b2cc Leon, P. (Patricia)|||/items/0e2474ff-17cc-4a69-80e9-75d2b3d21c07 Malaga, G. (German)|||/items/01612d24-6bde-4f9b-aeae-af75873feb96 Chaccour-Díaz, C.J. (Carlos Javier)|||/items/94d62c6d-ac64-42ab-b253-feb88e916983 Carcamo, C.P. (Cesar P.)|||/items/a42d10ac-736d-4c23-ae12-48dd17d18e6e |
| author |
Garcia, P.J. (Patricia J.)|||/items/f10ef114-39fd-4e49-bc75-e5be976071b0 |
| author_facet |
Garcia, P.J. (Patricia J.)|||/items/f10ef114-39fd-4e49-bc75-e5be976071b0 Mundaca, H. (Hansel)|||/items/e6fce9f7-0b77-4b71-98a6-e669a8604a72 Ugarte-Gil, C. (Cesar)|||/items/3db534ef-f47e-4ea7-a6d5-463d42b2b2cc Leon, P. (Patricia)|||/items/0e2474ff-17cc-4a69-80e9-75d2b3d21c07 Malaga, G. (German)|||/items/01612d24-6bde-4f9b-aeae-af75873feb96 Chaccour-Díaz, C.J. (Carlos Javier)|||/items/94d62c6d-ac64-42ab-b253-feb88e916983 Carcamo, C.P. (Cesar P.)|||/items/a42d10ac-736d-4c23-ae12-48dd17d18e6e |
| author_role |
author |
| author2 |
Mundaca, H. (Hansel)|||/items/e6fce9f7-0b77-4b71-98a6-e669a8604a72 Ugarte-Gil, C. (Cesar)|||/items/3db534ef-f47e-4ea7-a6d5-463d42b2b2cc Leon, P. (Patricia)|||/items/0e2474ff-17cc-4a69-80e9-75d2b3d21c07 Malaga, G. (German)|||/items/01612d24-6bde-4f9b-aeae-af75873feb96 Chaccour-Díaz, C.J. (Carlos Javier)|||/items/94d62c6d-ac64-42ab-b253-feb88e916983 Carcamo, C.P. (Cesar P.)|||/items/a42d10ac-736d-4c23-ae12-48dd17d18e6e |
| author2_role |
author author author author author author |
| dc.contributor.none.fl_str_mv |
Dadun. Depósito Académico Digital Universidad de Navarra |
| dc.subject.none.fl_str_mv |
COVID-19 Randomized controlled trial Protocol SARS-CoV-2 PCR Early treatment Ivermectin Antiviral Immunomodulatory Peru |
| topic |
COVID-19 Randomized controlled trial Protocol SARS-CoV-2 PCR Early treatment Ivermectin Antiviral Immunomodulatory Peru |
| description |
Objectives: The primary objective is to determine the effect of a daily dose of ivermectin administered in three consecutive days to non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of SARS-CoV-2 RNA by PCR from nasopharyngeal swabs at day seven post-treatment initiation. The secondary objectives are: 1. To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab on days 4, 7, 14 and 21 post-treatment initiation 2. To assess the efficacy of ivermectin on the improvement of symptoms 3. To assess the proportion of seroconversions at day 21 4. To assess the safety of ivermectin at the proposed dose 5. To determine the magnitude of the immune response against SARS-CoV-2 6. To assess correlation of the presence of intestinal helminths on participants on baseline and day 14 with COVID-19 progression and treatment. |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2021 2021-01-01 2021 2021-01-01 |
| dc.type.none.fl_str_mv |
journal article http://purl.org/coar/resource_type/c_6501 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
| format |
article |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/10171/115300 |
| url |
https://hdl.handle.net/10171/115300 |
| dc.language.none.fl_str_mv |
Inglés eng |
| language_invalid_str_mv |
Inglés |
| language |
eng |
| dc.rights.none.fl_str_mv |
open access http://purl.org/coar/access_right/c_abf2 |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 |
| eu_rights_str_mv |
openAccess |
| dc.format.none.fl_str_mv |
application/pdf |
| dc.publisher.none.fl_str_mv |
BioMed Central |
| publisher.none.fl_str_mv |
BioMed Central |
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reponame:Dadun. Depósito Académico Digital de la Universidad de Navarra instname:Universidad de Navarra |
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Universidad de Navarra |
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Dadun. Depósito Académico Digital de la Universidad de Navarra |
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Dadun. Depósito Académico Digital de la Universidad de Navarra |
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15,811543 |