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

March 4, 2021 updated by: Thomas Hiemstra, Cambridge University Hospitals NHS Foundation Trust

PROphylaxis for paTiEnts at Risk of COVID-19 infecTion (PROTECT): a Basket Trial of Prophylactic Interventions Amongst At-risk Patients

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Plaquenil
No Intervention: Control
Patients will continue with their usual medicines and clinical care without additional HCQ.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
To study completion, average 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: To study completion, average 6 months
Death from any cause
To study completion, average 6 months
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.
To study completion, average 6 months
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.
To study completion, average 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

University of Cambridge

Investigators

  • Principal Investigator: Thomas Hiemstra, PhD, Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A095590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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