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Covid19Phase 2NCT04513184

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

A Phase 2 study testing IV Dexamethasone and Nasal Dexamethasone in people with Covid19, run by Edda Sciutto Conde at 3 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Covid19
What is being tested?
IV Dexamethasone and Nasal Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
3 sitesMexico
Study dates
5 Nov 2021to 13 Nov 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Mexico3 sites

  • Hospital General de Mexico Dr. Eduardo Liceaga

    Mexico City, Mexico City, 06720

  • Instituto Nacional de Cardiología Ignacio Chávez

    Mexico City, Mexico City, 14080

  • El Instituto Nacional de Neurologia Y Neurocirugia Manuel Velasco Suarez

    Mexico City, Mexico City, 14269

Other trials in Mexico

About this study

This Clinical Trial evaluates nasal administration of Dexamethasone as an adjuvant treatment strategy for non-critically ill hospitalized participants with SARS CoV-2 infection.

Read the 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
Being tested
IV Dexamethasone, Nasal Dexamethasone
Keywords
Dexamethasone, SARS CoV-2 infection, COVID-19, Severe Acute Respiratory Syndrome, Nasal administration
Medical subject headings
COVID-19, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IV DexamethasoneDrug

    Also called ST

    6 mg from Day 1 to 10 after randomization

  • Nasal DexamethasoneDrug

    Also called Nasal DXM

    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.

Study groups in NCT04513184
Study groupRoleWhat they receive
Standard therapy (ST) onlyActive comparatorControl. Standard care and treatment only
Receives: Drug: IV Dexamethasone
DXMExperimentalNasal dexamethasone plus Standard care and treatment
Receives: Drug: Nasal Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 10 days after randomization

Secondary outcomes (4)

  1. Time-to-death from all causes

    All-cause mortality rates at 28 days after randomization

    Measured: 28 days after randomization

  2. Time free from mechanical ventilation

    Ventilator-free days, defined as alive and not requiring mechanical ventilation, at 10 days after randomization.

    Measured: 10 days after randomization

  3. Viral load

    Virological measurements, including proportions with detection of viral RNA over time and measurements of viral RNA titer area under the curve (AUC).

    Measured: 10 days after randomization

  4. Length of hospital stay

    Length of hospital stay in days

    Measured: 10 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2020
  2. Study start5 Nov 2021
  3. Primary completion12 Nov 2021
  4. Study completion13 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, randomized, controlled trial adult patients with confirmed COVID-19 infection
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04513184
Sponsor's protocol ID
DI/20/407/04/36
Status last verified
Dec 2022
First submitted
12 Aug 2020
Last updated
14 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Information exchange for research purposes

Publications

  • 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, Sarmiento EB, Reynoso RIA, Reyes DM, Del Rio Ambriz LR, Hernandez JSG, Cruz J, Ferrer SIV, Huerta L, Fierro NA, Hernandez M, Perez-Tapia M, Meneses G, Rosas G, Hernandez-Aceves JA, Cervantes-Torres J, Valdez RA, Rodriguez AF, Espindola-Arriaga E, Ortiz M, Salazar EA, Barba CC, Besedovsky H, Romano MC, Jung H, Bobes RJ, Soldevila G, Lopez-Alvarenga JC, Fragoso G, Laclette JP, Sciutto E. Intranasal Versus Intravenous Dexamethasone to Treat Hospitalized COVID-19 Patients: A Randomized Multicenter Clinical Trial. Arch Med Res. 2024 Feb;55(2):102960. doi: 10.1016/j.arcmed.2024.102960. Epub 2024 Jan 29.

    PubMed 38290199

  • 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.

    PubMed 35164840

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IV Dexamethasone and Nasal Dexamethasone in people with Covid19, run by Edda Sciutto Conde at 3 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of clinical improvement (time frame: 10 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04513184, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.

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