Open, randomized, adaptive and phase III clinical trial study to evaluate the efficacy of various pharmacological alternatives in the treatment of severe infection in COVID-19 pediatric patients
Description of the Study:
- Title: Randomized Clinical Trial to Evaluate the Efficacy of different Treatments in Patients with COVID-19 who Require Hospitalization.
- Principal Investigator: Ana Méndez Echevarría.
- Centers of Implementation: Hospital La Paz, Hospital 12 de Octubre, Hospital Gregorio Marañón, Hospital Clínico Santiago de Compostela, Hospital La Fe, Hospital Vall d’Hebron, Hospital Sant Joan de Déu, Hospital Virgen del Rocío and Hospital Materno-Infantil Málaga.
- Study Population: any child from 1 month to 18 years of age who requires admission for infection confirmed by SARS-CoV-2 with PCR or rapid test and is subsidiary of treatment according to medical criteria.
- Study Type: Randomized controlled clinical trial.
- Design: Adaptive. At the present time, the treatment under evaluation is hydroxychloroquine vs hydroxychloroquine plus azithromycin.
Objectives of the Study:
Principal Objective: Provide reliable estimates of the effects of different antiviral treatments on hospital mortality.
More about this Study:
Added value: The adaptive design of this study allows treatment arms to be added / removed while the trial is ongoing and based on the results that are obtained within of the essay or in the literature COVID-19.
Hospital Universitario La Paz: Hospital Universitario La Paz is a public hospital center, dependent on the Community of Madrid, located in the north of Madrid. Since the inauguration of the Hospital General in July 1964, its appearance has changed and grown to become the great hospital complex that we know today, made up of a network of 17 buildings and four large hospitals: the General Hospital, the Maternal Hospital, the Children’s Hospital and the Traumatology and Rehabilitation Hospital.