Clinical trial NCT04513184: Randomized Clinical Trial of Intranasal Dexamethasone as an Adjuvant in Patients With COVID-19
Official title: Randomized Clinical Trial of Intranasal Dexamethasone as an Adjuvant in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Keywords: Dexamethasone
SARS CoV-2 infection
COVID-19
Severe Acute Respiratory Syndrome
Nasal administration
Lead sponsor: Universidad Nacional Autonoma de Mexico
Sponsor class: OTHER
Collaborators: name: Hospital General de México Dr. Eduardo Liceaga
name: Instituto Nacional de Cardiologia Ignacio Chavez
name: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
First posted: 2020-08-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, controlled trial adult patients with confirmed COVID-19 infection
Primary purpose: TREATMENT

Brief summary: This Clinical Trial evaluates nasal administration of Dexamethasone as an adjuvant treatment strategy for non-critically ill hospitalized participants with SARS CoV-2 infection.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Positive diagnosis of SARS-CoV-2 by real-time RT-PCR in oropharyngeal sample.
* 7 days or more after the start of the infection
* Hospitalized patients with moderate to severe respiratory complications that do not have received mechanical ventilation.
* Patients receiving standard therapy at the Hospital General de México Eduardo Liceaga.
* Signing of the informed consent form
* Patients of both sexes (non-pregnant female) 18 years of age or older will be eligible if they have a positive diagnostic sample by RT-PCR, pneumonia confirmed by chest imaging and oxygen saturation (SaO2) \< 93% at ambient air or a ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2) (PaO2: FiO2) at 300 mg Hg or less

Exclusion Criteria:

* Patients participating in another research protocol.
* Patients receiving oral or intravenous glucocorticoids
* Immunosuppressed patients (including HIV infection)
* Glaucoma patients.
* Patients with allergy to dexamethasone.
* Pregnant or lactating women
* Concomitant autoimmune diseases
* Refusal by the patient or family to participate in the study

Primary outcomes:
measure: Time of clinical improvement
timeFrame: 10 days after randomization
Secondary outcomes:
measure: Time-to-death from all causes
timeFrame: 28 days after randomization
measure: Time free from mechanical ventilation
timeFrame: 10 days after randomization
measure: Viral load
timeFrame: 10 days after randomization
measure: Length of hospital stay
timeFrame: 10 days after randomization
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General de Mexico Dr. Eduardo Liceaga
state: Cdmx
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiología Ignacio Chávez
state: Cdmx
city: Mexico City
country: Mexico
facility: El Instituto Nacional de Neurologia Y Neurocirugia Manuel Velasco Suarez
state: Cdmx
Study officials:
affiliation: Instituto de Investigaciones Biomédicas, UNAM
name: Edda Sciutto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.