The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

The PATCH trial (Prevention And Treatment of COVID-19 with Hydroxychloroquine) is funded investigator-initiated trial that includes 3 cohorts. Cohort 1: a double-blind placebo controlled trial of high dose HCQ as a treatment for home bound COVID-19 positive patients; Cohort 2: a randomized study testing different doses of HCQ in hospitalized patients; Cohort 3: a double blind placebo controlled trial of low dose HCQ as a preventative medicine in health care workers.

Key facts

Study ID

NCT04329923

Run by

Ravi Amaravadi, MD

People needed

173

Starts

2020-04-09

Expected to finish

2020-11-13

Last updated by the study team

2020-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥ 18 years old (Sub-studies 2 and 3)
• Competent and capable to provide informed consent
• Have access to a smart device such as a cell phone, tablet, laptop computer with necessary data/internet accessibility
• Subjects meeting the following criteria by Sub-Study
• Sub-Study 1:
• Age ≥40 years since the risk of prolonged disease that progresses to severe COVID-19 disease increases with age.
• PCR-positive for the SARS-CoV2 virus
• (Fever, and cough, or Fever and shortness of breath,
• ≤4 days since the first symptoms of COVID-19 and date of testing
• Not taking azithromycin
• Not requiring hospitalization and is sent home for quarantine.
• Must live within 30 miles of HUP or Penn Presbytarian Medical Center to facilitate drop-off of medication
• Must own a working computer, or smartphone and have internet access
• Must be willing to fill out a daily symptom diary
• Must be available for a daily phone call,
• Must take their own temperature twice a day
• Must be willing to report the observed symptoms and development of COVID-19 in the co-inhabitants of the residence at which the quarantine will be served.
• Sub-Study 2 Hospitalized non-ICU service patients.
• PCR-positive for SARS-CoV-2
• Patients admitted to a floor bed at Hospital of the University of Pennsylvania or Penn Presbyterian.
• One or more of the following risk factors for progression to severe disease including: immunocompromising conditions, structural lung disease, hypertension, coronary artery disease, diabetes, age > 60, ferritin > 850, CRP > 6, D-dimer > 1000 Sub-Study 3 Health Care Worker Prevention
• Emergency Medicine or Infectious Disease Team physician or nurse at HUP or PPMC
• ≥20 hours per week of clinical work scheduled in the coming 2 months during the COVID-19 pandemic
• No fever, cough, or shortness of breath in the past 2 weeks
• Willing to report compliance with HCQ in the form of a diary

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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