Randomized Clinical Trial of Intranasal Dexamethasone as an Adjuvant in Patients With COVID-19
- Registration Number
- NCT04513184
- Lead Sponsor
- Edda Sciutto Conde
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard therapy (ST) only IV Dexamethasone Control. Standard care and treatment only DXM Nasal Dexamethasone Nasal dexamethasone plus Standard care and treatment
- Primary Outcome Measures
Name Time Method Time of clinical improvement 10 days after randomization Evaluation of the clinical status of patients after randomization, defined as a two point improvement in the WHO 7-point Ordinal Scale
- Secondary Outcome Measures
Name Time Method Time free from mechanical ventilation 10 days after randomization Ventilator-free days, defined as alive and not requiring mechanical ventilation, at 10 days after randomization.
Viral load 10 days after randomization Virological measurements, including proportions with detection of viral RNA over time and measurements of viral RNA titer area under the curve (AUC).
Length of hospital stay 10 days after randomization Length of hospital stay in days
Time-to-death from all causes 28 days after randomization All-cause mortality rates at 28 days after randomization
Trial Locations
- Locations (3)
Instituto Nacional de Cardiología Ignacio Chávez
🇲🇽Mexico City, Cdmx, Mexico
El Instituto Nacional de Neurologia Y Neurocirugia Manuel Velasco Suarez
🇲🇽Mexico City, Cdmx, Mexico
Hospital General de Mexico Dr. Eduardo Liceaga
🇲🇽Mexico City, Cdmx, Mexico