Status:
COMPLETED
Randomized Clinical Trial of Intranasal Dexamethasone as an Adjuvant in Patients With COVID-19
Lead Sponsor:
Edda Sciutto Conde
Collaborating Sponsors:
Hospital General de México Dr. Eduardo Liceaga
Instituto Nacional de Cardiologia Ignacio Chavez
Conditions:
Covid19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04513184
Start Date
November 5 2021
End Date
November 13 2021
Last Update
December 14 2022
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital General de Mexico Dr. Eduardo Liceaga
Mexico City, Mexico City, Mexico, 06720
2
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Mexico City, Mexico, 14080
3
El Instituto Nacional de Neurologia Y Neurocirugia Manuel Velasco Suarez
Mexico City, Mexico City, Mexico, 14269