Early Treatment to Patients with Coronavirus (COVID)

Phase 1

• Conditions: This trial will investigate infection with coronavirus (COVID-19) in patients who are admitted to hospital; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001198-55-DK
• Lead Sponsor: Chronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-21
• Study Completion: 2021-02-02
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

- Patients admitted to a danish emergency department or department of respiratory medicine or internal medicine
- Age >18 år
- Hospitalized <48 hours
- Positive COVID-19 test/diagnosis during hospitalization
- fertile women must present a negative pregnancy test
- signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190

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

Study & Design

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