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PROphylaxis for paTiEnts at Risk of COVID-19 infecTion (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389359
Recruitment Status : Withdrawn (Regulatory approvals not received)
First Posted : May 15, 2020
Last Update Posted : March 8, 2021
Sponsor:
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
Thomas Hiemstra, Cambridge University Hospitals NHS Foundation Trust

Study Description
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Brief Summary:
The PROTECT open-label randomised basket trial will assess the effectiveness of hydroxychloroquine (HCQ) as chemoprophylaxis against COVID-19 in multiple vulnerable populations in the United Kingdom.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Sulfate 200 MG Phase 2 Phase 3

Detailed Description:

COVID-19 (novel coronavirus-induced disease) was declared a global pandemic by the WHO on 11th March 2020. Currently there are no drugs proven to treat or delay progression of COVID-19 and no vaccine is yet available. Efforts are underway to repurpose established drugs with well understood drug interactions and safety profiles. Vulnerable populations such as those receiving in-centre dialysis are largely excluded from ongoing trials.

The PROTECT Basket clinical trial aims to enrol patients at particularly high risk of COVID-19 and its complications, seeking to test treatments that either might prevent the disease from occurring or may reduce the number of cases where the disease becomes serious or life-threatening. The PROTECT trial will use innovative design and analysis methodologies to allow the simultaneous assessment of one or more treatments in multiple populations.

Patients will be eligible for recruitment to the trial if they fall within one of the following vulnerable populations: a) patients receiving in-centre haemodialysis, b) transplant patients, c) vasculitis, or d) other disease groups that may be added during the course of this trial.

PROTECT will use an innovate basket design to carry out a series of individually powered prospective, randomised comparisons in distinct vulnerable patient groups in the UK while applying Bayesian approaches to conduct pooled assessment of efficacy.

Once consented, eligible participants will be randomised to active treatment or control, stratified by PROTECT subpopulation (disease specific). Enrolment to the trial will be via an online platform and following informed consent subsequent assessments will be done via email or telephone thus reducing the burden to participants as well as reducing their exposure to COVID-19.

The master PROTECT protocol describes core components that are shared between disease specific appendices to the core protocol.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: PROTECT will use an innovative basket design to conduct a series of prospective, randomised comparisons in multiple vulnerable patient groups in the United Kingdom with the capabilities of assessing effects within specific patients groups, and across the pooled PROTECT cohort. Additional interventions may be added as these become available. Basket Trial design brings greater efficiency, due to running multiple comparisons within one master protocol. It also allows application of innovative Bayesian analysis methods that allow adaptive borrowing of information across populations. This will mean in the case that there is a consistent effect across populations, the trial will have greater power to find significant differences for individual patient groups.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PROphylaxis for paTiEnts at Risk of COVID-19 infecTion (PROTECT): a Basket Trial of Prophylactic Interventions Amongst At-risk Patients
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HCQ group (dialysis)

Dialysis patients will receive Hydroxychloroquine sulfate 200 mg capsules or tablets (oral administration), as 600mg weekly in divided doses, given as 200mg after each dialysis session.

Non-dialysis patients will receive Hydroxychloroquine sulfate, 400mg twice daily for two days, then 400mg weekly.

Maximum treatment duration will be 26 weeks (6 months).

 Drug: Hydroxychloroquine Sulfate 200 MG
Hydroxychloroquine Sulfate administered orally for a maximum of 6 months. Doses population specific.
Other Name: Plaquenil
No Intervention: Control
Patients will continue with their usual medicines and clinical care without additional HCQ.


Outcome Measures
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Primary Outcome Measures :
  1. Time to confirmed diagnosis of COVID-19 [ Time Frame: To study completion, average 6 months ]
    The primary outcome for PROTECT is the time to confirmed COVID-19 infection from the date of randomisation. This will be captured via linkage with PHE or by direct reporting by sites.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: To study completion, average 6 months ]
    Death from any cause

  2. Severity of COVID-19 disease [ Time Frame: To study completion, average 6 months ]
    Severity will be assessed by requirement for hospitalisation, HDU/ICU admission or death and Length of inpatient stay.

  3. Incidence of COVID-19 complications [ Time Frame: To study completion, average 6 months ]
    Acute respiratory distress syndrome, viral pneumonitis, myocarditis/myocardial injury, acute kidney injury.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have no previous confirmed COVID-19 diagnosis
  • Fall into one of the high risk population groups

Exclusion Criteria:

  • Inability to provide informed consent
  • Symptomatic for possible COVID-19 at baseline or symptoms highly suggestive of COVID-19 experienced since 1st March 2020
  • Hypersensitivity reaction to hydroxychloroquine, chloroquine or 4-aminoquinolines or any formulation excipients
  • Contraindication to taking hydroxychloroquine as prophylaxis e.g known epilepsy
  • Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines
  • History of any retinopathy including diabetic retinopathy requiring laser therapy
  • Taking medications which are contra-indicated alongside HCQ - Digoxin, Halofantrine, Amiodarone, Moxifloxacin, Cyclosporin, Mefloquine, Praziquantel, Tamoxifen
  • Known history of prolonged QTc
  • Type I diabetes or insulin-dependent type II diabetes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389359


Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Investigators
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Principal Investigator: Thomas Hiemstra, PhD Cambridge University Hospitals NHS Foundation Trust
More Information
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Responsible Party: Thomas Hiemstra, Honorary Consultant Nephrologist, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04389359    
Other Study ID Numbers: A095590
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Hiemstra, Cambridge University Hospitals NHS Foundation Trust:
haemodialysis
transplant
immunosuppression
vasculitis
 hydroxychloroquine
chemoprophylaxis
COVID-19
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents