PROphylaxis for paTiEnts at Risk of COVID-19 infecTion

• Status: Withdrawn
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborator: University of Cambridge
• Treatments: Hydroxychloroquine

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