Trials / Terminated
TerminatedNCT04363827
Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)
PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 155 (actual)
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hydroxychloroquine | Hydroxychloroquine |
Timeline
- Start date
- 2020-05-14
- Primary completion
- 2021-09-30
- Completion
- 2021-09-30
- First posted
- 2020-04-27
- Last updated
- 2025-03-10
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04363827. Inclusion in this directory is not an endorsement.