This trial will investigate infection with coronavirus (COVID-19) in patients who are admitted to hospital MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Azithromycin
Product Name: Azithromycin
Product Code: Azithromycin
Pharmaceutical Form: Capsule
INN or Proposed INN: Azithromycin
CAS Number: 121470-24-4
Other descriptive name: AZITHROMYC
Sponsors
Chronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients admitted to a danish emergency department or department of respiratory medicine or internal medicine - Age >18 år - Hospitalized =65 years) yes F.1.3.1 Number of subjects for this age range 190
Exclusion criteria
Exclusion criteria: - If the patient uses >5 LO2/min on time of recruitment - Known intolerance/allergy to azithromcyin or hydroxychloroquine - Liver diseases other than amoebiasis - Severe gastrointestinal, neurological and hematological disorders -eGFR <45 ml/min/1.73m2 - Severe cardiac conduction disorders or (risk of) prolonged QT interval - Myasthenia gravis - Neurogenic hearing loss - Psoriasis - Retinopathy - Maculopathy - Visual fiels changes - Breastfeeding - Hypersensitivity to quinine or 4-aminoquinoderivates -Uses Digoxin - Shortage of glucose-6-phosphatedehydrogenase - Porphyria - Hypoglycemia - Severe mental illness which significantly complicates cooperation - Severe linguistic problems that significantly complicates cooperation - Concomitant administration of sickle alkaloids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients who are admitted urgently to hospital with coronavirus infection (COVID-19) and symptoms, treatment with virus-modifying agent Hydroxyhloroquine as well as virus-immunomodulatory and antibacterial drug Azithromycin can lead to a shorter hospitalization.;Secondary Objective: The secondary objectives are to clarify whether the patients riscs of non-invasive ventilation, intensive care unit admittance and death can be reduced by hydroxychloroquine and azithromycine treatment. ;Primary end point(s): Days alive and discharged from hospital within 14 days ;Timepoint(s) of evaluation of this end point: 15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint nr 1: Patient will be categorized within 1 of the following 8 categories on day 15: 1. Dead 2. Admitted, uses mecanical ventilate or ExtraCorporalMembranOxygering (ECMO) 3. Admitted, uses Non-invasive ventilation or "high-flow oxygen device" 4. Admitted, gets oxygen but doesn't live up to (2) or (3) 5. Admitted, no need for oxygen treatment but gets other treatment (COVID related or other) 6. Admitted for observation 7. Discharged, but with limitations of activity level 8. Discharged, no limitations of activity level - Admitted to intensive care unit then Length of Stay, ICU - has used Non-invasive ventilation (NIV) during hospitalization - death on day 30 - Length of index-hospitalization (days) - days alive and discharged from hospital within 30 days - death on day 90 - death within 12 months - number of readmissions (all causes) within 30 days - number of days of non-invasive ventilation (NIV) - Delta PaO2 day 1 to day 4 - Delta PaCO2 day 1 to day 4 - pH day 4 (72 hours) - Time without oxygen supplement (or regular LTOT oxygen supplement);Timepoint(s) of evaluation of this end point: 15 days and 1 year | — |
Countries
Denmark
Contacts
Public Contactwww.coptrin.dk
COP:TRIN
Outcome results
None listed