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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513184
• Other study ID #: DI/20/407/04/36
• Status: Completed
• Phase: Phase 2
• Start date: November 5, 2021
• Est. completion date: November 13, 2021

Study information

• Verified date: December 2022
• Source: Universidad Nacional Autonoma de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 13, 2021
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• IV Dexamethasone
6 mg from Day 1 to 10 after randomization
• Nasal Dexamethasone
0.12 mg/kg/daily for 3 days from day 1, followed by 0.06 mg/kg/daily from day 4 to 10 after randomization.

Locations

Country	Name	City	State
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	Instituto Nacional de Cardiología Ignacio Chávez	Mexico City	Cdmx

Sponsors (4)

Lead Sponsor	Collaborator
Edda Sciutto Conde	El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez, Hospital General de México Dr. Eduardo Liceaga, Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of clinical improvement	Evaluation of the clinical status of patients after randomization, defined as a two point improvement in the WHO 7-point Ordinal Scale	10 days after randomization
Secondary	Time-to-death from all causes	All-cause mortality rates at 28 days after randomization	28 days after randomization
Secondary	Time free from mechanical ventilation	Ventilator-free days, defined as alive and not requiring mechanical ventilation, at 10 days after randomization.	10 days after randomization
Secondary	Viral load	Virological measurements, including proportions with detection of viral RNA over time and measurements of viral RNA titer area under the curve (AUC).	10 days after randomization
Secondary	Length of hospital stay	Length of hospital stay in days	10 days after randomization