Randomized Clinical Trial of Intranasal Dexamethasone as an Adjuvant in Patients With COVID-19

Edda Sciutto Conde

Status and phase: Completed; Phase 2

Conditions: Covid19

Treatments: Drug: Nasal Dexamethasone; Drug: IV Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04513184

DI/20/407/04/36

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Standard therapy (ST) only

Active Comparator group

Description:

Control. Standard care and treatment only

Treatment:

Drug: IV Dexamethasone

DXM

Experimental group

Description:

Nasal dexamethasone plus Standard care and treatment

Treatment:

Drug: Nasal Dexamethasone