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Clinical Trials/EUCTR2020-001363-85-DK
EUCTR2020-001363-85-DK
Active, not recruiting
Phase 1

COVID-19 Prophylaxis with hydroxychloroquine, Vitamin D, and Zinc supplementation in Danish nursing home residents – a randomized controlled trial - COVID-19 PREVENTIO

Odense University Hospital0 sites206 target enrollmentApril 17, 2020
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ConditionsHealthy volunteer (Prophylaxis for COVID-19)MedDRA version: 20.0Level: PTClassification code 10049087Term: Antiviral prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsPlaquenil

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Healthy volunteer (Prophylaxis for COVID-19)
Sponsor
Odense University Hospital
Enrollment
206
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 17, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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