Platform Randomised trial of INterventions against COVID-19 In older people

Phase 1

• Conditions: Suspected COVID-19; MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001209-22-GB
• Lead Sponsor: niversity of Oxford / Clinical Trials and Research Governance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-25
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.

• Participant is willing to comply with all trial procedures

• Onset of symptoms of possible COVID-19 in the community (continuous cough and/or high temperature) within 7 days of inclusion

• Patients aged =50-64 years with any of the following listed comorbidities:

- known weakened immune system due to a serious illness or medication (e.g. chemotherapy)
- known heart disease
- known asthma or lung disease
- known diabetes not treated with insulin
- known mild hepatic impairment
- known stroke or neurological problem

OR

• Patients aged =65 with or without comorbidity

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2500

Exclusion Criteria

• Pregnancy
• Breastfeeding
• Known severe hepatic impairment
• Known severe renal impairment
• Known acute porphyrias
• Type 1 diabetes or insulin dependent Type 2 Diabetes mellitus
• Known G6PD deficiency
• Known myasthenia gravis
• Known severe Psoriasis
• Known severe neurological disorders (especially those with a history of epilepsy may lower seizure threshold)
• Previous adverse reaction to, or currently taking, hydroxychloroquine
• Known retinal disease
• Judgement of the recruiting clinician deems ineligibile

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified