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

Phase 2

• Conditions: COVID 19; Acute Respiratory Distress Syndrome ARDS; SARS-CoV Infection
• Interventions: Drug: Remdesivir; Drug: Hydroxychloroquine; Other: (Standard of Care) SoC

• Registration Number: NCT04321616
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-25
• Study Start: 2020-03-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-10
• Last Update Posted: 2020-04-14
• Primary Completion: 2020-08
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remdesivir	(Standard of Care) SoC	-
Hydroxychloroquine	(Standard of Care) SoC	-
Hydroxychloroquine	Remdesivir	-
Remdesivir	Hydroxychloroquine	-
Control group - SoC	Hydroxychloroquine	-
Control group - SoC	Remdesivir	-

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	3 weeks	All cause in-hospital mortality

Secondary Outcome Measures

Name	Time	Method
Occurrence and duration of intensive care unit (ICU) treatment	3 weeks
Duration of hospital admittance	1 month
28 Day mortality	3 weeks
Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen	3 weeks
Occurrence of co-infections	3 weeks
Occurrence of organ dysfunction	3 months
Occurrence and duration of mechanical ventilation	3 weeks

Trial Locations

Locations (1)

Andreas Barratt-Due; 🇳🇴 Oslo, Norway