PROphylaxis for paTiEnts at Risk of COVID-19 infecTion

NCT04389359 | Withdrawn Phase 2 DMC

• 1 other identifier: A095590
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Keywords

haemodialysis; transplant; immunosuppression; vasculitis; hydroxychloroquine; chemoprophylaxis; COVID-19

Outcome Measures

Primary Outcomes (1)

• Time to confirmed diagnosis of COVID-19

  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 Outcomes (3)

• All-cause mortality

  To study completion, average 6 months

• Severity of COVID-19 disease

  To study completion, average 6 months

• Incidence of COVID-19 complications

  To study completion, average 6 months

Study Arms (2)

HCQ group (dialysis)

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients will continue with their usual medicines and clinical care without additional HCQ.

Interventions

Hydroxychloroquine Sulfate 200 MG DRUG

Hydroxychloroquine Sulfate administered orally for a maximum of 6 months. Doses population specific.

Also known as: Plaquenil

HCQ group (dialysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator

MeSH Terms

Conditions

COVID-19; Vasculitis

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; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Thomas Hiemstra, PhD

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Consultant Nephrologist

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: September 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2025
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share