Status:

WITHDRAWN

PROphylaxis for paTiEnts at Risk of COVID-19 infecTion

Lead Sponsor:

Cambridge University Hospitals NHS Foundation Trust

Collaborating Sponsors:

University of Cambridge

Conditions:

COVID-19

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

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.

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2025

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04389359

Start Date

September 1 2020

End Date

August 1 2025

Last Update

March 8 2021

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