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

NCT04329923 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 842838
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• Time to Release From Quarantine Time

  Cohort 1 (home quarantined COVID-19 patients): Median time to release from quarantine by meeting the following criteria: 1) No fever for 72 hours 2) improvement in other symptoms and 3) 7 or 10 days (depending on CDC guidance at the time) have elapsed since the beginning of symptom onset.

  until quarantine release or hospitalization

• Time to Hospital Discharge

  Cohort 2 (hospitalized COVID-19 patients): median number of days until hospital discharge

  until hospital discharge

• Number of Health Care Workers Who Developed SARS-COV-2 Infection

  Cohort 3 Physicians and nurse prophylaxis: Rate of COVID-19 infection at 2 months

  2 months

Secondary Outcomes (2)

• Rate of Housemate Infection

  until quarantine release, or approximately <20 days

• Rate of Hospitalization

  until quarantine release

Study Arms (6)

Cohort 1 HCQ

ACTIVE COMPARATOR

COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with hydroxychloroquine 400 mg twice a day for up to 14 days

Drug: Hydroxychloroquine Sulfate 400 mg twice a day

Cohort 1 Placebo

PLACEBO COMPARATOR

COVID-19 PCR+ patients quarantined at home randomized to this arm will be treated with placebo twice a day for up to 14 days. Crossover is allowed if symptoms worsen after 7 days of treatment.

Drug: Placebo oral tablet

Cohort 2 HCQ high dose

EXPERIMENTAL

Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days

Drug: Hydroxychloroquine Sulfate 600 mg twice a day

Cohort 2 HCQ low dose

ACTIVE COMPARATOR

Hospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days

Drug: Hydroxychloroquine Sulfate 600 mg once a day

Cohort 3 HCQ

EXPERIMENTAL

Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for 2 months

Drug: Hydroxychloroquine Sulfate 600 mg once a day

Cohort 3 Placebo

PLACEBO COMPARATOR

Health care workers at high risk of contracting COVID-19 randomized to this arm will be treated with placebo for 2 month. Crossover is allowed if subject becomes SARS-CoV2 positive.

Drug: Placebo oral tablet

Interventions

Hydroxychloroquine Sulfate 400 mg twice a day DRUG

Antimalarial compound

Also known as: Plaquenil

Cohort 1 HCQ

Hydroxychloroquine Sulfate 600 mg twice a day DRUG

Antimalarial compound

Also known as: Plaquenil

Cohort 2 HCQ high dose

Hydroxychloroquine Sulfate 600 mg once a day DRUG

Antimalarial compound

Also known as: Plaquenil

Cohort 2 HCQ low dose; Cohort 3 HCQ

Placebo oral tablet DRUG

Placebo

Also known as: Placebo

Cohort 1 Placebo; Cohort 3 Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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,

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ravi Amaravadi, MD: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 33001138 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Sub-study 1 was terminated early after the first interim analysis due to slow accrual Sub-study 2 was terminated early after the first 7 patients based on the recommendation of UPenn research oversight committees Sub-study 3 was terminated early due to meeting futility criteria on a pre-specified second interim analysis

Results Point of Contact

• Title: Amelia Anderson
• Organization: UPenn

amelia.anderson@pennmedicine.upenn.edu

215-509-5690

Study Officials

• Ravi Amaravadi, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Cohorts 1 and 3 are double-blind placebo control cohorts. Cohort 2 is an open label randomized study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: There are 3 cohorts. All partcipants in of each the cohorts are randomized to one of two arms

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: April 9, 2020
• Primary Completion: November 11, 2020
• Study Completion: November 13, 2020
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year after study completion
• Access Criteria: Open access

Locations

US (1)