COVID-19Phase 2PATCHNCT04329923

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

A Phase 2 study testing Hydroxychloroquine Sulfate 400 mg twice a day, Hydroxychloroquine Sulfate 600 mg twice a day and Hydroxychloroquine Sulfate 600 mg once a day in people with COVID-19, run by Ravi Amaravadi, MD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Hydroxychloroquine Sulfate 400 mg twice a day, Hydroxychloroquine Sulfate 600 mg twice a day and Hydroxychloroquine Sulfate 600 mg once a day
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 173 participants
Where: 1 siteUnited States
Study dates: 9 Apr 2020to 13 Nov 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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:

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Conditions: COVID-19
Being tested: Hydroxychloroquine Sulfate 400 mg twice a day, Hydroxychloroquine Sulfate 600 mg twice a day, Hydroxychloroquine Sulfate 600 mg once a day, Placebo oral tablet
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydroxychloroquine Sulfate 400 mg twice a dayDrug
Also called Plaquenil
Antimalarial compound
Hydroxychloroquine Sulfate 600 mg twice a dayDrug
Also called Plaquenil
Antimalarial compound
Hydroxychloroquine Sulfate 600 mg once a dayDrug
Also called Plaquenil
Antimalarial compound
Placebo oral tabletDrug
Also called Placebo
Placebo

Study groups in NCT04329923
Study group	Role	What they receive
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 Receives: 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. Receives: 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 Receives: 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 Receives: 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 Receives: 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. Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: until quarantine release or hospitalization
Time to Hospital Discharge
Cohort 2 (hospitalized COVID-19 patients): median number of days until hospital discharge
Measured: 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
Measured: 2 months

Secondary outcomes (2)

Rate of Housemate Infection
Cohort 1 rate of participant-reported secondary infection of housemates
Measured: until quarantine release, or approximately <20 days
Rate of Hospitalization
Cohort 1 rate of hospitalization
Measured: until quarantine release

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Apr 202013 Nov 2020

First posted1 Apr 2020
Study start9 Apr 2020
Primary completion11 Nov 2020
Study completion13 Nov 2020

Why it stopped: Cohort 1: slow accrual Cohort 2: Other studies showed no benefit Cohort 3: Study met pre-specificied futility analysis at planned second interim analysis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: There are 3 cohorts. All partcipants in of each the cohorts are randomized to one of two arms
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04329923
Sponsor's protocol ID: 842838
Acronym: PATCH
Status last verified: Dec 2020
First submitted: 30 Mar 2020
Last updated: 10 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: We will publish our results in a peer-reviewed journal and make available de-identified data for additional analysis

Publications

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.
PubMed 33001138

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The PATCH Trial (Prevention And Treatment of COVID-19 With Hydroxychloroquine)
ClinicalTrials.gov ID: NCT04329923
Acronym / sponsor ID: PATCH / 842838
Conditions: COVID-19
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Cohort 1: slow accrual Cohort 2: Other studies showed no benefit Cohort 3: Study met pre-specificied futility analysis at planned second interim analysis
Enrolment: 173 participants (actual)
Lead sponsor: Ravi Amaravadi, MDUniversity, hospital or other
Study start: 9 Apr 2020 (actual)
Primary completion: 11 Nov 2020 (actual)
Study completion: 13 Nov 2020 (actual)
First posted: 1 Apr 2020 (actual)
Results: Posted 10 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6
Model description: There are 3 cohorts. All partcipants in of each the cohorts are randomized to one of two arms

Arm	Type	Receives
Cohort 1 HCQ	Active comparator	Drug: Hydroxychloroquine Sulfate 400 mg twice a dayCOVID-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
Cohort 1 Placebo	Placebo comparator	Drug: Placebo oral tabletCOVID-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.
Cohort 2 HCQ high dose	Experimental	Drug: Hydroxychloroquine Sulfate 600 mg twice a dayHospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg twice a day for up to 14 days
Cohort 2 HCQ low dose	Active comparator	Drug: Hydroxychloroquine Sulfate 600 mg once a dayHospitalized COVID-19 PCR+ patients randomized to this arm will be treated with hydroxychloroquine 600 mg once a day for up to 7 days
Cohort 3 HCQ	Experimental	Drug: Hydroxychloroquine Sulfate 600 mg once a dayHealth 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
Cohort 3 Placebo	Placebo comparator	Drug: Placebo oral tabletHealth 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

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
Age ≥40 years since the risk of prolonged disease that progresses to severe COVID-19 disease increases with age.

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydroxychloroquine Sulfate 400 mg twice a dayAlso: PlaquenilAntimalarial compound	Drug	Cohort 1 HCQ
Hydroxychloroquine Sulfate 600 mg twice a dayAlso: PlaquenilAntimalarial compound	Drug	Cohort 2 HCQ high dose
Hydroxychloroquine Sulfate 600 mg once a dayAlso: PlaquenilAntimalarial compound	Drug	Cohort 2 HCQ low dose, Cohort 3 HCQ
Placebo oral tabletAlso: PlaceboPlacebo	Drug	Cohort 1 Placebo, Cohort 3 Placebo

Primary outcome

Time to Release From Quarantine Time
Time frame: until quarantine release or hospitalization
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.
Time to Hospital Discharge
Time frame: until hospital discharge
Cohort 2 (hospitalized COVID-19 patients): median number of days until hospital discharge
Number of Health Care Workers Who Developed SARS-COV-2 Infection
Time frame: 2 months
Cohort 3 Physicians and nurse prophylaxis: Rate of COVID-19 infection at 2 months

2 secondary outcomes

Rate of Housemate Infection
Time frame: until quarantine release, or approximately <20 days
Rate of Hospitalization
Time frame: until quarantine release

Results and safety

Results posted to the registry on 10 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 HCQ	17	16
Cohort 1 Placebo	17	13
Cohort 2 HCQ High Dose	4	3
Cohort 2 HCQ Low Dose	3	2
Cohort 3 HCQ	66	64
Cohort 3 Placebo	66	61

Primary outcome: Time to Release From Quarantine Time

Time frame: until quarantine release or hospitalization. Median (Full Range). Unit: days

Measure	Cohort 1 HCQ n = 15	Cohort 1 Placebo n = 13
Value	8 (4 to 19)	11 (4 to 18)

Cohort 1 HCQ vs Cohort 1 Placebo: Cox Proportional Hazard: 0.58, p = 0.28, Regression, Cox

Population analysed: randomized patients that were released from quarantine on study

Primary outcome: Time to Hospital Discharge

Time frame: until hospital discharge. Median (Full Range). Unit: days

Measure	Cohort 2 HCQ High Dose n = 4	Cohort 2 HCQ Low Dose n = 3
Value	5.5 (2 to 15)	4 (3 to 15)

Primary outcome: Number of Health Care Workers Who Developed SARS-COV-2 Infection

Time frame: 2 months. Count of participants. Unit: Participants

Measure	Cohort 3 HCQ n = 64	Cohort 3 Placebo n = 61
Value	4	4

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 HCQ	1 of 17 (5.9%)	6 of 17 (35.3%)	0 of 17
Cohort 1 Placebo	0 of 17 (0%)	3 of 17 (17.6%)	0 of 17
Cohort 2 HCQ High Dose	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Cohort 2 HCQ Low Dose	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Cohort 3 HCQ	0 of 66 (0%)	29 of 66 (43.9%)	0 of 66
Cohort 3 Placebo	0 of 66 (0%)	15 of 66 (22.7%)	0 of 66

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33001138Abella 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.
Individual participant dataSharing planned: Yes. We will publish our results in a peer-reviewed journal and make available de-identified data for additional analysis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ravi Amaravadi, MD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Release From Quarantine Time (time frame: until quarantine release or hospitalization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04329923, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.