The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients

University of Oslo (UIO)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: SARS-CoV Infection; Acute Respiratory Distress Syndrome ARDS; COVID 19

Treatments: Drug: Hydroxychloroquine; Other: (Standard of Care) SoC; Drug: Remdesivir

Study type: Interventional

Funder types: Other

Identifiers

NCT04321616

118684

Details and patient eligibility

About

The (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients, 18 years and above
2. Confirmed SARS-2-CoV-2 infection by PCR
3. Admitted to the hospital ward or the ICU
4. Subjects (or legally authorized representative) provides written informed consent prior to initiation of the study

Exclusion criteria

1. Severe co-morbidity with life expectancy <3 months according to investigators assessment
2. (Aspartate Transaminase/ Alanine Aminotransferase) ASAT/ALAT > 5 times the upper limit of normal
3. Acute co-morbidity within 7 days before inclusion such as myocardial infarction
4. Known intolerance to the available study drugs
5. Pregnancy, possible pregnancy or breast feeding
6. Any reason why, in the opinion of the investigators, the patient should not participate
7. Subject participates in a potentially confounding drug or device trial during the course of the study
8. Prolonged QT interval (>450 ms)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 3 patient groups

Hydroxychloroquine

Active Comparator group

Treatment:

Other: (Standard of Care) SoC

Drug: Remdesivir

Remdesivir

Active Comparator group

Treatment:

Other: (Standard of Care) SoC

Drug: Hydroxychloroquine

Control group - SoC

Active Comparator group

Treatment:

Drug: Remdesivir

Drug: Hydroxychloroquine