ORWEGIAN CORONAVIRUS DISEASE 2019 [NO-COVID-19] STUDY: A TRIAL TO EVALUATE THE ANTIVIRAL EFFECT OF CHLOROQUINE IN ADULT PATIENTS WITH SARS-COV-2 INFECTIO
Phase 1
- Conditions
- SARS-COV-2 infectionMedDRA version: 21.1Level: LLTClassification code 10037373Term: Pulmonary disorderSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001010-38-NO
- Lead Sponsor
- Akershus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
1.Hospitalised
2.Adults 18 year or older
3.Moderately severe disease (NEWS score = 6)
4.SARS-CoV-2 positive nasopharyngeal swab
5.Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160
Exclusion Criteria
1.Requiring ICU admission at screening
2.History of psoriasis
3.Tinnitus, reduced hearing
4.Visual impairment
5.Known adverse reaction to hydroxychloroquine sulphate
6.Pregnancy
7.Prolonged QT interval (>450 ms)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method