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Trial - NCT04332094


Column Value
Trial registration number NCT04332094
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04332094

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Pere Domingo, MD, PhD

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

pdomingo@santpau.cat

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-02

Recruitment status
Last imported at : May 8, 2023, midnight
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : May 8, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure. - understand and agree to abide by the study procedures. - adult #18 years of age at the time of inclusion in the study. - confirmation of sars-cov-2 infection by a microbiological test performed before randomization, no longer than 72 hours. - severity 3-4 according to the who 7-point ordinal scale.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- alt / ast> 5 times the normal limit - stage 4 chronic kidney disease (gfr <30) or requiring dialysis. - presence of comorbidities that imply a poor prognosis (according to clinical judgment). - advanced dementia. - pregnancy or breastfeeding. - anticipation of transfer to another center in the 12 hours at the beginning of the study. - allergy to study medication. - serious or active bacterial infections or documented sepsis by pathogens other than sars-cov-2. - streptococcus pneumoniae antigenuria positive before study start. - neutropenia <500 / mm3. - thrombocytopenia <100,000 / mm3. - history of diverticulosis. - ongoing skin infection (eg, pyodermitis). - transplanted patient under immunosuppressive treatment. - previous evidence of latent untreated tuberculosis.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Spain

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

276

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Need for mechanical ventilation in the Intensive Care Unit;In-hospital mortality

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

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

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1425, "treatment_name": "Azithromycin+hydroxychloroquine+tocilizumab", "treatment_type": "Antibiotics+antimalarials+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]