Healthy volunteer (Prophylaxis for COVID-19) MedDRA version: 20.0 Level: PT Classification code 10049087 Term: Antiviral prophylaxis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862
Conditions
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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 o Macrolides, quinolones, voriconazole, psychotropics with high risk of QT prolongation, amiodarone, or methadone Intake of the following medication due to potential interaction o Digoxin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether prophylactic treatment with daily hydroxychloroquine, vitamin D, and zinc supplementation reduces the risk of COVID-19, the severity of the disease, the hospitalization rate, and death in nursing home residents.;Secondary Objective: To assess the effect of prophylactic treatment with hydroxychloroquine, vitamin D, and zinc compared with no treatment in nursing home residents not previously infected with SARS-CoV-2 on: - SARS-CoV-2 positive real-time PCR from nasopharyngeal samples - Influenza positive real-time PCR from nasopharyngeal samples - Hospitalization (related) - Hospitalization (any) - Need for intensive care respiratory support if hospitalized - Length of disease course - Contact to general practitioner (any) - Side effects (stomach pain, nausea, reduced appetite, diarrhea, vomiting, headache, skin rash, decreased hepatic functioning, or prolonged cardiac QT interval) - Death (30 days, 90 days) ;Primary end point(s): SARS-CoV-2 positive rtPCR from nasopharyngeal samples during 2 months prophylactic treatment with hydroxychloroquine, vitamin D, and zinc supplement or no prophylactic treatment;Timepoint(s) of evaluation of this end point: 0, 30, 60, and 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinically evident COVID-19 2. Influenza positive real-time PCR from nasopharyngeal samples 3. Hospitalization (related) 4. Hospitalization (any) 5. Need for intensive care respiratory support if hospitalized 6. Length of disease course 7. Contact to general practitioner (any) 8. Death 9. Adherence to intervention 10. SARS-CoV-2 positive rtPCR in participants with severe cognitive dysfunction ;Timepoint(s) of evaluation of this end point: 1: 0, 30, 60, and 90 days 2: 0, 30, 60, and 90 days 3: 30, 60, and 90 days 4: 30, 60, and 90 days 5: 30, 60, and 90 days 6: 30, 60, and 90 days 7: 30, 60, and 90 days 8: 30, and 90 days 9: 60 days 10: 0, 30, 60 and 90 days | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Information
Odense University Hospital
Outcome results
None listed