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

SARS-CoV Infection Clinical Trial

Official title:

The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04321616
• Other study ID #: 118684
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 28, 2020
• Est. completion date: November 2020

Study information

• Verified date: April 2020
• Source: Oslo University Hospital
• Contact: Paul Aukrust, MD, Professor
• Phone: 0047 46778374
• Email: paukrust[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: November 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome ARDS
• Coronavirus Infections
• COVID 19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine will be given orally (in the ICU in gastrointestinal tubes) with 800 mg x 2 loading dose followed by 400 mg x 2 every day for a total of 10 days.
• Remdesivir
Remdesivir will be given intravenously 100 mg daily for the duration of the hospitalization and up to 10 days total course. A loading dose of 200 mg at inclusion will be given.

Other:
• (Standard of Care) SoC
The standard of care will be supplied to all patients not receiving a drug intervention.

Locations

Country	Name	City	State
Norway	Andreas Barratt-Due	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inflammatory and anti-inflammatory mediators as assessed in serum and plasma		Throughout hospitalization
Other	Markers of extracellular matrix remodeling		Throughout hospitalization and 3 months after remission
Other	Markers of endothelial activation		Throughout hospitalization
Other	Markers of platelet activation		Throughout hospitalization
Primary	In-hospital mortality	All cause in-hospital mortality	3 weeks
Secondary	Occurrence and duration of mechanical ventilation		3 weeks
Secondary	Occurrence and duration of intensive care unit (ICU) treatment		3 weeks
Secondary	Duration of hospital admittance		1 month
Secondary	28 Day mortality		3 weeks
Secondary	Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen		3 weeks
Secondary	Occurrence of co-infections		3 weeks
Secondary	Occurrence of organ dysfunction		3 months