| Study name |
Randomised clinical trial of intranasal dexamethasone as an adjuvant in patients with COVID‐19 |
| Methods |
Trial design: multicentre, double‐masked (participant, care provider), RCT
Sample size: 60
Setting: inpatient
Language: Spanish, English
Number of centres: 3
Type of intervention (treatment/prevention): treatment |
| Participants |
Inclusion criteria
18 to 75 years old Positive diagnosis of SARS‐CoV‐2 by real‐time RT‐PCR in oropharyngeal sample ≥ 7 days after the start of the infection Hospitalised patients with moderate to severe respiratory complications that have not 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 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 PaO2: FiO2 at ≤ 300 mmHg
Exclusion criteria
Patients participating in another research protocol Patients receiving oral or IV 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
|
| Interventions |
Details of intervention
Treatment details of control group (e.g. dose, route of administration): 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 randomisation
Concomitant therapy: no information |
| Outcomes |
Primary outcome
Evaluation of the clinical status of patients after randomisation, defined as a 2‐point improvement in the WHO 7‐point Ordinal Scale Time of clinical improvement (time frame: 10 days after randomisation)
|
| Starting date |
14 July 2020 |
| Contact information |
Graciela A Cárdenas‐Hernández, PhD: +525556063822 ext 2012
Email: gracielacardenas@yahoo.com.mx |
| Notes |
Recruitment status: recruiting
Prospective completion date: primary completion date 30 March 2021 estimated study completion date 31 July 2021
Date last update was posted: 12 November 2020
Sponsor/funding: Edda Sciutto Conde |
