Clinical trial NCT04329923: The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)
Official title: The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 3 cohorts. All partcipants in of each the cohorts are randomized to one of two arms
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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
* Patients must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.

Exclusion Criteria \<18 years of age

* Prisoners or other detained persons
* Allergy to hydroxychloroquine Pregnant or lactating or positive pregnancy test
* Receiving any treatment drug for 2019-ncov within 14 days prior to screening evaluation (off label, compassionate use or trial related).
* Co-enrollment onto another COVID-19 study is not allowed unless there is approval by the Medical Monitor in consultation with the PI and EM and ID sub-I leaders.
* Known history of retinal disease including but not limited to age related macular degeneration.
* Taking any of the following medications that prolong Qtc:

Chlorpromazine.Haloperidol, Droperidol, Quetiapine, Olanzapine. Amisulpride. Thioridazine

* History of interstitial lung disease or chronic pneumonitis unrelated COVID-19.
* Due to risk of disease exacerbation patients with porphyria or psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.
* Patients with serious intercurrent illness that requires active infusional therapy, intense monitoring, or frequent dose adjustments for medication including but not limited to infectious disease, cancer, autoimmune disease, cardiovascular disease.
* Patients who have undergone major abdominal, thoracic, spine or CNS surgery in the last 2 months, or plan to undergo surgery during study participation.
* Patients receiving cytochrome P450 enzyme-inducing anticonvulsant drugs (i.e. phenytoin, carbamazepine, Phenobarbital, primidone or oxcarbazepine) within 4 weeks of the start of the study treatment
* History or evidence of increased cardiovascular risk including any of the following:
* Left ventricular ejection fraction (LVEF) \< institutional lower limit of normal. Baseline echocardiogram is not required.
* A QT interval corrected for heart rate using the Frederica formula \> 500 msec (Sub-study 2)
* Current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation
* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to enrollment
* Current ≥ Class II congestive heart failure as defined by New York Heart Association

Primary outcomes:
measure: Time to Release From Quarantine Time
timeFrame: until quarantine release or hospitalization
measure: Time to Hospital Discharge
timeFrame: until hospital discharge
measure: Number of Health Care Workers Who Developed SARS-COV-2 Infection
timeFrame: 2 months
Secondary outcomes:
measure: Rate of Housemate Infection
timeFrame: until quarantine release, or approximately <20 days
measure: Rate of Hospitalization
timeFrame: until quarantine release
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ravi Amaravadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abella BS, Jolkovsky EL, Biney BT, Uspal JE, Hyman MC, Frank I, Hensley SE, Gill S, Vogl DT, Maillard I, Babushok DV, Huang AC, Nasta SD, Walsh JC, Wiletyo EP, Gimotty PA, Milone MC, Amaravadi RK; Prevention and Treatment of COVID-19 With Hydroxychloroquine (PATCH) Investigators. Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care Workers: A Randomized Clinical Trial. JAMA Intern Med. 2021 Feb 1;181(2):195-202. doi: 10.1001/jamainternmed.2020.6319.