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

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ClinicalTrials.gov Identifier: NCT04513184
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborators:
Hospital General de México Dr. Eduardo Liceaga
Instituto Nacional de Cardiologia Ignacio Chavez
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Information provided by (Responsible Party):
Edda Sciutto Conde, Universidad Nacional Autonoma de Mexico

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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: IV Dexamethasone Drug: Nasal Dexamethasone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized, controlled trial adult patients with confirmed COVID-19 infection
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Intranasal Dexamethasone as an Adjuvant in Patients With COVID-19
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
Active Comparator: Standard therapy (ST) only
Control. Standard care and treatment only
Drug: IV Dexamethasone
6 mg from Day 1 to 10 after randomization
Other Name: ST

Experimental: DXM
Nasal dexamethasone plus Standard care and treatment
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.
Other Name: Nasal DXM




Primary Outcome Measures :
  1. Time of clinical improvement [ Time Frame: 10 days after randomization ]
    Evaluation of the clinical status of patients after randomization, defined as a two point improvement in the WHO 7-point Ordinal Scale


Secondary Outcome Measures :
  1. Time-to-death from all causes [ Time Frame: 28 days after randomization ]
    All-cause mortality rates at 28 days after randomization

  2. Time free from mechanical ventilation [ Time Frame: 10 days after randomization ]
    Ventilator-free days, defined as alive and not requiring mechanical ventilation, at 10 days after randomization.

  3. Viral load [ Time Frame: 10 days after randomization ]
    Virological measurements, including proportions with detection of viral RNA over time and measurements of viral RNA titer area under the curve (AUC).

  4. Length of hospital stay [ Time Frame: 10 days after randomization ]
    Length of hospital stay in days



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513184


Contacts
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Contact: Graciela A Cárdenas-Hernández, PhD +525556063822 ext 2012 gracielacardenas@yahoo.com.mx
Contact: María Chavez-Canales, PhD 525527282179 maria@iibiomedicas.unam.mx

Locations
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Mexico
Hospital General de Mexico Dr. Eduardo Liceaga Recruiting
Mexico City, Cdmx, Mexico, 06720
Contact: Ana María H Espinosa-García, PhD    5527892000 ext 1683    anaesga@hotmail.com   
Contact: Joselín Hernández-Ruiz, PhD    5527892000 ext 1683    hernandezjoselin@hotmail.com   
Instituto Nacional de Cardiología Ignacio Chávez Recruiting
Mexico City, Cdmx, Mexico, 14080
Contact: María Chávez-Canales, PhD    525527282179    maria@iibiomedicas.unam.mx   
El Instituto Nacional de Neurologia Y Neurocirugia Manuel Velasco Suarez Not yet recruiting
Mexico City, Cdmx, Mexico, 14269
Contact: Graciela Cárdenas-Hernández, PhD    525556063822 ext 2012    gracielacardenas@yahoo.com.mx   
Sponsors and Collaborators
Edda Sciutto Conde
Hospital General de México Dr. Eduardo Liceaga
Instituto Nacional de Cardiologia Ignacio Chavez
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Investigators
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Principal Investigator: Edda Sciutto, PhD Instituto de Investigaciones Biomédicas, UNAM
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Responsible Party: Edda Sciutto Conde, Researcher, Universidad Nacional Autonoma de Mexico
ClinicalTrials.gov Identifier: NCT04513184    
Other Study ID Numbers: DI/20/407/04/36
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information exchange for research purposes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Upon study completion, by request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edda Sciutto Conde, Universidad Nacional Autonoma de Mexico:
Dexamethasone
SARS CoV-2 infection
COVID-19
Severe Acute Respiratory Syndrome
Nasal administration
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action