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| Name | Class |
|---|---|
| Hospital General de México Dr. Eduardo Liceaga | OTHER_GOV |
| Instituto Nacional de Cardiologia Ignacio Chavez | OTHER |
| El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez | OTHER |
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This Clinical Trial evaluates nasal administration of Dexamethasone as an adjuvant treatment strategy for non-critically ill hospitalized participants with SARS CoV-2 infection.
Approximately 30% of the admitted patients with Covid-19 require admission to the intensive care unit for respiratory assistance, ranging from a high flow nasal cannula to invasive ventilation. These patients are affected by respiratory dysfunctions and even dysfunction of the brain respiratory control centers. Additionally, exacerbated inflammation leads to endothelial and coagulation disorders that aggravate the course of the illness. No effective therapy has yet been found to treat forms SARS-CoV-2 bass. One of the adjunctive therapeutic alternatives addressed is the use of intravenously administered glucocorticoids (GC), aimed at reducing exacerbated peripheral inflammation. They have been used at early stages of infection in high doses and with controversial results. In our laboratory at the Biomedical Research Institute from the National Autonomous University of Mexico (UNAM), we have shown that dexamethasone, a GC (DXM) administered intranasally, reaches the central nervous system through the olfactory nerve (alike various pathogens, including coronaviruses) and reduces neuroinflammation more effectively than when applied intravenously. Additionally, biodistribution studies indicate that the DXM is detectable from the first minute after its application, both in the central nervous system and in the respiratory system. The objective of this study is to evaluate the safety, efficacy and tolerability of dexamethasone in patients hospitalized with SARS-CoV-2 with moderate-severe forms, with an without the requirement of mechanic ventilation, including syndrome of acute respiratory distress or pneumonia (as diagnosed by CAT) with alveolar / interstitial lung involvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy (ST) only | Active Comparator | Control. Standard care and treatment only |
|
| DXM | Experimental | Nasal dexamethasone plus Standard care and treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Dexamethasone | Drug | 6 mg from Day 1 to 10 after randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time of clinical improvement | Evaluation of the clinical status of patients after randomization, defined as a two point improvement in the WHO 7-point Ordinal Scale | 10 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-death from all causes | All-cause mortality rates at 28 days after randomization | 28 days after randomization |
| Time free from mechanical ventilation | Ventilator-free days, defined as alive and not requiring mechanical ventilation, at 10 days after randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edda Sciutto, PhD | Instituto de Investigaciones Biomédicas, UNAM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Mexico Dr. Eduardo Liceaga | Mexico City | Mexico City | 06720 | Mexico | ||
| Instituto Nacional de CardiologÃa Ignacio Chávez |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35164840 | Derived | Cardenas G, Chavez-Canales M, Espinosa AM, Jordan-Rios A, Malagon DA, Murillo MFM, Araujo LVT, Campos RLB, Wong-Chew RM, Gonzalez LER, Cresencio KI, Velazquez EG, de la Cerda MR, Leyva Y, Hernandez-Ruiz J, Hernandez-Medel ML, Leon-Hernandez M, Quero KM, Moncivais AS, Diaz SH, Martinez IRZ, Martinez-Cuazitl A, Salazar INM, Sarmiento EB, Pena AF, Hernandez PS, Reynoso RIA, Reyes DM, Del Rio Ambriz LR, Bonilla RAA, Cruz J, Huerta L, Fierro NA, Hernandez M, Perez-Tapia M, Meneses G, Espindola-Arriaga E, Rosas G, Chinney A, Mendoza SR, Hernandez-Aceves JA, Cervantes-Torres J, Rodriguez AF, Alor RO, Francisco SO, Salazar EA, Besedovsky H, Romano MC, Bobes RJ, Jung H, Soldevila G, Lopez-Alvarenga J, Fragoso G, Laclette JP, Sciutto E. Intranasal dexamethasone: a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients. Trials. 2022 Feb 14;23(1):148. doi: 10.1186/s13063-022-06075-5. |
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Information exchange for research purposes
Upon study completion, by request
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Multicenter, randomized, controlled trial adult patients with confirmed COVID-19 infection
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| Nasal Dexamethasone | Drug | 0.12 mg/kg/daily for 3 days from day 1, followed by 0.06 mg/kg/daily from day 4 to 10 after randomization. |
|
|
| 10 days after randomization |
| Viral load | Virological measurements, including proportions with detection of viral RNA over time and measurements of viral RNA titer area under the curve (AUC). | 10 days after randomization |
| Length of hospital stay | Length of hospital stay in days | 10 days after randomization |
| Mexico City |
| Mexico City |
| 14080 |
| Mexico |
| El Instituto Nacional de Neurologia Y Neurocirugia Manuel Velasco Suarez | Mexico City | Mexico City | 14269 | Mexico |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |