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

• Status: Recruiting
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Edda Sciutto Conde
• Collaborators: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez; Hospital General de México Dr. Eduardo Liceaga; Instituto Nacional de Cardiologia Ignacio Chavez; Instituto Nacional de Neurologia y Neurocirugia Manuel Velazco Suarez
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

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