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Trial - NCT04726098


Column Value
Trial registration number NCT04726098
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04726098

First author
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

Manuel Taboada Muñiz, Ph.D.

Contact
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

manutabo@yahoo.es

Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-01-27

Recruitment status
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - age 18 years or older. - hospitalized covid-19 patients admitted to the hospital. - patients requiring supplemental oxygen. level 4 using the world health organization 7-point ordinal scale for clinical improvement - patients requiring corticosteroids (dexamethasone) according to hospital protocol.

Exclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- pregnancy or active lactation. - patient is expected to die in the next 48 hours. - known history of dexamethasone allergy or known contraindication to the use of corticosteroids. - daily use of corticosteroids in the past 15 days. - indication for corticosteroids use for other clinical conditions (e.g. refractory septic shock). - consent refusal for participating in the trial. - different level of 4 in level 4 using the world health organization 7-point ordinal scale for clinical improvement.

Number of arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Manuel Taboada Muñiz

Inclusion age min
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Spain

Type of patients
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

198

primary outcome
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Percentage of patients with treatment failure at day 11

Notes
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "High dose", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Low dose", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]