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

NCT ID: NCT04513184

Last Updated: 2022-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-05
• Study Completion Date: 2021-11-13

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.

Conditions

Covid19

Keywords

Dexamethasone; SARS CoV-2 infection; COVID-19; Severe Acute Respiratory Syndrome; Nasal administration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard therapy (ST) only

Control. Standard care and treatment only

Group Type: ACTIVE_COMPARATOR

IV Dexamethasone

Intervention Type: DRUG

6 mg from Day 1 to 10 after randomization

DXM

Nasal dexamethasone plus Standard care and treatment

Group Type: EXPERIMENTAL

Nasal Dexamethasone

Intervention Type: DRUG

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.

Interventions

IV Dexamethasone

6 mg from Day 1 to 10 after randomization

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

ST; Nasal DXM

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General de México Dr. Eduardo Liceaga

OTHER_GOV

Sponsor Role: collaborator

Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role: collaborator

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

OTHER

Sponsor Role: collaborator

Edda Sciutto Conde

OTHER

Sponsor Role: lead

Responsible Party

Edda Sciutto Conde

Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Edda Sciutto, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigaciones Biomédicas, UNAM

Locations

Hospital General de Mexico Dr. Eduardo Liceaga

Mexico City, Mexico City, Mexico

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Mexico City, Mexico

El Instituto Nacional de Neurologia Y Neurocirugia Manuel Velasco Suarez

Mexico City, Mexico City, Mexico

Countries

Mexico

References

Cardenas G, Chavez-Canales M, Espinosa AM, Jordan-Rios A, Malagon DA, Murillo MFM, Araujo LVT, Campos RLB, Wong-Chew RM, Gonzalez LER, Cresencio KI, Velazquez EG, de la Cerda MR, Leyva Y, Hernandez-Ruiz J, Hernandez-Medel ML, Leon-Hernandez M, Quero KM, Moncivais AS, Diaz SH, Martinez IRZ, Martinez-Cuazitl A, Salazar INM, Sarmiento EB, Pena AF, Hernandez PS, Reynoso RIA, Reyes DM, Del Rio Ambriz LR, Bonilla RAA, Cruz J, Huerta L, Fierro NA, Hernandez M, Perez-Tapia M, Meneses G, Espindola-Arriaga E, Rosas G, Chinney A, Mendoza SR, Hernandez-Aceves JA, Cervantes-Torres J, Rodriguez AF, Alor RO, Francisco SO, Salazar EA, Besedovsky H, Romano MC, Bobes RJ, Jung H, Soldevila G, Lopez-Alvarenga J, Fragoso G, Laclette JP, Sciutto E. Intranasal dexamethasone: a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients. Trials. 2022 Feb 14;23(1):148. doi: 10.1186/s13063-022-06075-5.

Reference Type: DERIVED

PMID: 35164840 (View on PubMed)

Other Identifiers

DI/20/407/04/36

Identifier Type: -

Identifier Source: org_study_id