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

NCT04513184 | Completed Phase 2 DMC

• 1 other identifier: DI/20/407/04/36
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time-to-death from all causes

  28 days after randomization

• Time free from mechanical ventilation

  10 days after randomization

• Viral load

  10 days after randomization

• Length of hospital stay

  10 days after randomization

Study Arms (2)

Standard therapy (ST) only

ACTIVE COMPARATOR

Control. Standard care and treatment only

Drug: IV Dexamethasone

DXM

EXPERIMENTAL

Nasal dexamethasone plus Standard care and treatment

Drug: Nasal Dexamethasone

Interventions

IV Dexamethasone DRUG

6 mg from Day 1 to 10 after randomization

Also known as: ST

Standard therapy (ST) only

Nasal Dexamethasone 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.

Also known as: Nasal DXM

DXM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive diagnosis of SARS-CoV-2 by real-time RT-PCR in oropharyngeal sample.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edda Sciutto Conde: lead
• Hospital General de México Dr. Eduardo Liceaga: collaborator
• Instituto Nacional de Cardiologia Ignacio Chavez: collaborator
• El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez: collaborator

Study Sites (3)

Hospital General de Mexico Dr. Eduardo Liceaga

Mexico City, Mexico City, 06720, Mexico

Location

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Mexico City, 14080, Mexico

Location

El Instituto Nacional de Neurologia Y Neurocirugia Manuel Velasco Suarez

Mexico City, Mexico City, 14269, Mexico

Location

Related Publications (1)

• 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.

  PMID: 35164840 DERIVED

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Edda Sciutto, PhD

  Instituto de Investigaciones Biomédicas, UNAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Model Details: Multicenter, randomized, controlled trial adult patients with confirmed COVID-19 infection

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 14, 2020
• Study Start: November 5, 2021
• Primary Completion: November 12, 2021
• Study Completion: November 13, 2021
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Upon study completion, by request

Locations

ME (3)