Medication for prevention of Corona-virus for Danish nursing home residents

Phase 1

• Conditions: Healthy volunteer (Prophylaxis for COVID-19); MedDRA version: 20.0Level: PTClassification code 10049087Term: Antiviral prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001363-85-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-17
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

-Nursing home residents
-= 65 years of age
-Able to give informed consent or consent by proxy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 206

Exclusion Criteria

-Prior SARS-CoV-2 positive rtPCR test
-Terminal illness
-Current prescription of hydroxychloroquine or chloroquine
-Allergy to hydroxychloroquine or chloroquine
-Known to suffer from either of the following: Cardiomyopathy; G6PD deficiency; Retinopathy; Severe hearing -deficits; QT prolongation; Child Pugh Score = C; psoriasis, myasthenia gravis; dysregulated diabetes, eGFR < 20 ml/min
-Deemed unable to swallow oral tablets
-Intake of the following medication due to potential QT prolongation
oMacrolides, quinolones, voriconazole, psychotropics with high risk of QT prolongation, amiodarone, or methadone
Intake of the following medication due to potential interaction
oDigoxin

Study & Design

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