Intranasal dexamethasone : a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients
© 2022. The Author(s)..
BACKGROUND: By end December of 2021, COVID-19 has infected around 276 million individuals and caused over 5 million deaths worldwide. Infection results in dysregulated systemic inflammation, multi-organ dysfunction, and critical illness. Cells of the central nervous system are also affected, triggering an uncontrolled neuroinflammatory response. Low doses of glucocorticoids, administered orally or intravenously, reduce mortality among moderate and severe COVID-19 patients. However, low doses administered by these routes do not reach therapeutic levels in the CNS. In contrast, intranasally administered dexamethasone can result in therapeutic doses in the CNS even at low doses.
METHODS: This is an approved open-label, multicenter, randomized controlled trial to compare the effectiveness of intranasal versus intravenous dexamethasone administered in low doses to moderate and severe COVID-19 adult patients. The protocol is conducted in five health institutions in Mexico City. A total of 120 patients will be randomized into two groups (intravenous vs. intranasal) at a 1:1 ratio. Both groups will be treated with the corresponding dexamethasone scheme for 10 days. The primary outcome of the study will be clinical improvement, defined as a statistically significant reduction in the NEWS-2 score of patients with intranasal versus intravenous dexamethasone administration. The secondary outcome will be the reduction in mortality during hospitalization.
CONCLUSIONS: This protocol is currently in progress to improve the efficacy of the standard therapeutic dexamethasone regimen for moderate and severe COVID-19 patients.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04513184 . Registered November 12, 2020. Approved by La Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) with identification number DI/20/407/04/36. People are currently being recruited.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
|---|---|
| Enthalten in: |
Trials - 23(2022), 1 vom: 14. Feb., Seite 148 |
| Sprache: |
Englisch |
|---|
| Links: |
|---|
| Themen: |
7S5I7G3JQL |
|---|
| Anmerkungen: |
Date Completed 16.02.2022 Date Revised 07.12.2022 published: Electronic ClinicalTrials.gov: NCT04513184 Citation Status MEDLINE |
|---|
| doi: |
10.1186/s13063-022-06075-5 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM336969376 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM336969376 | ||
| 003 | DE-627 | ||
| 005 | 20231225233342.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2022 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1186/s13063-022-06075-5 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1123.xml |
| 035 | |a (DE-627)NLM336969376 | ||
| 035 | |a (NLM)35164840 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Cárdenas, Graciela |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Intranasal dexamethasone |b a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 16.02.2022 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04513184 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022. The Author(s). | ||
| 520 | |a BACKGROUND: By end December of 2021, COVID-19 has infected around 276 million individuals and caused over 5 million deaths worldwide. Infection results in dysregulated systemic inflammation, multi-organ dysfunction, and critical illness. Cells of the central nervous system are also affected, triggering an uncontrolled neuroinflammatory response. Low doses of glucocorticoids, administered orally or intravenously, reduce mortality among moderate and severe COVID-19 patients. However, low doses administered by these routes do not reach therapeutic levels in the CNS. In contrast, intranasally administered dexamethasone can result in therapeutic doses in the CNS even at low doses | ||
| 520 | |a METHODS: This is an approved open-label, multicenter, randomized controlled trial to compare the effectiveness of intranasal versus intravenous dexamethasone administered in low doses to moderate and severe COVID-19 adult patients. The protocol is conducted in five health institutions in Mexico City. A total of 120 patients will be randomized into two groups (intravenous vs. intranasal) at a 1:1 ratio. Both groups will be treated with the corresponding dexamethasone scheme for 10 days. The primary outcome of the study will be clinical improvement, defined as a statistically significant reduction in the NEWS-2 score of patients with intranasal versus intravenous dexamethasone administration. The secondary outcome will be the reduction in mortality during hospitalization | ||
| 520 | |a CONCLUSIONS: This protocol is currently in progress to improve the efficacy of the standard therapeutic dexamethasone regimen for moderate and severe COVID-19 patients | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov NCT04513184 . Registered November 12, 2020. Approved by La Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) with identification number DI/20/407/04/36. People are currently being recruited | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Dexamethasone | |
| 650 | 4 | |a Inflammation | |
| 650 | 4 | |a Intranasal administration | |
| 650 | 4 | |a Neuroinflammation | |
| 650 | 7 | |a Dexamethasone |2 NLM | |
| 650 | 7 | |a 7S5I7G3JQL |2 NLM | |
| 700 | 1 | |a Chávez-Canales, María |e verfasserin |4 aut | |
| 700 | 1 | |a Espinosa, Ana María |e verfasserin |4 aut | |
| 700 | 1 | |a Jordán-Ríos, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Malagon, Daniel Anica |e verfasserin |4 aut | |
| 700 | 1 | |a Murillo, Manlio Fabio Márquez |e verfasserin |4 aut | |
| 700 | 1 | |a Araujo, Laura Victoria Torres |e verfasserin |4 aut | |
| 700 | 1 | |a Campos, Ricardo Leopoldo Barajas |e verfasserin |4 aut | |
| 700 | 1 | |a Wong-Chew, Rosa María |e verfasserin |4 aut | |
| 700 | 1 | |a González, Luis Esteban Ramirez |e verfasserin |4 aut | |
| 700 | 1 | |a Cresencio, Karent Ibet |e verfasserin |4 aut | |
| 700 | 1 | |a Velázquez, Enrique García |e verfasserin |4 aut | |
| 700 | 1 | |a de la Cerda, Mariana Rodriguez |e verfasserin |4 aut | |
| 700 | 1 | |a Leyva, Yoana |e verfasserin |4 aut | |
| 700 | 1 | |a Hernández-Ruiz, Joselin |e verfasserin |4 aut | |
| 700 | 1 | |a Hernández-Medel, María Luisa |e verfasserin |4 aut | |
| 700 | 1 | |a León-Hernández, Mireya |e verfasserin |4 aut | |
| 700 | 1 | |a Quero, Karen Medina |e verfasserin |4 aut | |
| 700 | 1 | |a Monciváis, Anahí Sánchez |e verfasserin |4 aut | |
| 700 | 1 | |a Díaz, Sergio Hernández |e verfasserin |4 aut | |
| 700 | 1 | |a Martínez, Ignacia Rosalia Zeron |e verfasserin |4 aut | |
| 700 | 1 | |a Martínez-Cuazitl, Adriana |e verfasserin |4 aut | |
| 700 | 1 | |a Salazar, Iván Noé Martínez |e verfasserin |4 aut | |
| 700 | 1 | |a Sarmiento, Eduardo Beltrán |e verfasserin |4 aut | |
| 700 | 1 | |a Peña, Aldo Figueroa |e verfasserin |4 aut | |
| 700 | 1 | |a Hernández, Patricia Saraí |e verfasserin |4 aut | |
| 700 | 1 | |a Reynoso, Rafel Ignacio Aguilar |e verfasserin |4 aut | |
| 700 | 1 | |a Reyes, Daniela Murillo |e verfasserin |4 aut | |
| 700 | 1 | |a Del Río Ambriz, Luis Rodrigo |e verfasserin |4 aut | |
| 700 | 1 | |a Bonilla, Rogelio Antonio Alfaro |e verfasserin |4 aut | |
| 700 | 1 | |a Cruz, Jocelyn |e verfasserin |4 aut | |
| 700 | 1 | |a Huerta, Leonor |e verfasserin |4 aut | |
| 700 | 1 | |a Fierro, Nora Alma |e verfasserin |4 aut | |
| 700 | 1 | |a Hernández, Marisela |e verfasserin |4 aut | |
| 700 | 1 | |a Pérez-Tapia, Mayra |e verfasserin |4 aut | |
| 700 | 1 | |a Meneses, Gabriela |e verfasserin |4 aut | |
| 700 | 1 | |a Espíndola-Arriaga, Erick |e verfasserin |4 aut | |
| 700 | 1 | |a Rosas, Gabriela |e verfasserin |4 aut | |
| 700 | 1 | |a Chinney, Alberto |e verfasserin |4 aut | |
| 700 | 1 | |a Mendoza, Sergio Rosales |e verfasserin |4 aut | |
| 700 | 1 | |a Hernández-Aceves, Juan Alberto |e verfasserin |4 aut | |
| 700 | 1 | |a Cervantes-Torres, Jaquelynne |e verfasserin |4 aut | |
| 700 | 1 | |a Rodríguez, Anai Fuentes |e verfasserin |4 aut | |
| 700 | 1 | |a Alor, Roxana Olguin |e verfasserin |4 aut | |
| 700 | 1 | |a Francisco, Sandra Ortega |e verfasserin |4 aut | |
| 700 | 1 | |a Salazar, Evelyn Alvarez |e verfasserin |4 aut | |
| 700 | 1 | |a Besedovsky, Hugo |e verfasserin |4 aut | |
| 700 | 1 | |a Romano, Marta C |e verfasserin |4 aut | |
| 700 | 1 | |a Bobes, Raúl J |e verfasserin |4 aut | |
| 700 | 1 | |a Jung, Helgi |e verfasserin |4 aut | |
| 700 | 1 | |a Soldevila, Gloria |e verfasserin |4 aut | |
| 700 | 1 | |a López-Alvarenga, Juan |e verfasserin |4 aut | |
| 700 | 1 | |a Fragoso, Gladis |e verfasserin |4 aut | |
| 700 | 1 | |a Laclette, Juan Pedro |e verfasserin |4 aut | |
| 700 | 1 | |a Sciutto, Edda |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Trials |d 2006 |g 23(2022), 1 vom: 14. Feb., Seite 148 |w (DE-627)NLM161320430 |x 1745-6215 |7 nnns |
| 773 | 1 | 8 | |g volume:23 |g year:2022 |g number:1 |g day:14 |g month:02 |g pages:148 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1186/s13063-022-06075-5 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 23 |j 2022 |e 1 |b 14 |c 02 |h 148 | ||