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

NCT04321616 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2020-04-14

No results posted yet for this study

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.

Conditions

  • SARS-CoV Infection
  • COVID 19
  • Acute Respiratory Distress Syndrome ARDS

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Paul Aukrust, MD, Professor · Oslo University Hospital

  • Andreas Barratt-Due, MD, PhD · Oslo University Hospital

  • Trine Kåsine, MD · Oslo University Hospital

  • Katerina Nezvalova-Henriksen, Pharm D, PhD · Oslo Hospital Pharmacies

  • Anne Margarita Dyrhol Riise, MD, Professor · Oslo University Hospital

  • Marius Trøseid, MD, PhD · Oslo University Hospital

  • Inge Christoffer Olsen, PhD · NorCRIN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-28
Primary Completion
2020-08-31
Completion
2020-11-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321616 on ClinicalTrials.gov