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Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19) — PROTECT  

COVID19 Clinical Trial

Official title:
PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)

Clinical Trial Summary

This is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early phase COVID-19 population (Group 2). The participants will be randomised to receive either: Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).

Clinical Trial Description

This is an open label, superiority, cluster-randomized Italian interventional clinical trial, evaluating the role of Hydroxychloroquine versus observation only in preventing infection to COVID-19 or treating early phase COVID-19 patients. Each index case is randomised to either Arm A: Hydroxychloroquine or Arm B: observation in a 2:1 ratio on an open label basis. Participants in the same cluster receive the same intervention. Study population is constituted by: Group 1: Severe Acute Respiratory Syndrome (SARS) - Corona Virus (CoV)-2-exposed subjects , as household members/contacts of COVID-19 patients. Group 2: Patients with COVID-19 asymptomatic or paucisymptomatic in home situation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04363827
Study type Interventional
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 14, 2020
Completion date September 2021
View Details
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