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SARS-CoV InfectionPhase 2/3NCT04321616

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

A Phase 2/3 study testing Hydroxychloroquine and Remdesivir in people with SARS-CoV Infection and COVID 19, run by Oslo University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hydroxychloroquine and Remdesivir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
1 siteNorway
Study dates
28 Mar 2020to Nov 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Paul Aukrust, MD, Professor contact

0047 46778374

paukrust@ous-hf.no

Andreas Barratt-Due, MD, PhD contact

0047 98209974

andreas.barrattdue@gmail.com

Norway1 site, 1 recruiting

  • Andreas Barratt-Due

    Oslo, 0756

    ANDREAS BARRATT-DUE, PhD, +47 98209974, andreas.barrattdue@gmail.com

    Pål Aukrust, PhD, +47 46778374, paukrust@ous-hf.no

    Recruiting

Other trials in Norway

About this study

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

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.

Being tested
Hydroxychloroquine, Remdesivir, (Standard of Care) SoC
Keywords
Effect of drugs, Adverse effects of drugs, SARS-CoV clearance, Duration of artificial ventilation, Duration of intensive care stay, Duration of hospital stay
Medical subject headings
Severe Acute Respiratory Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroxychloroquineDrug

    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.

  • RemdesivirDrug

    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.

  • (Standard of Care) SoCOther

    The standard of care will be supplied to all patients not receiving a drug intervention.

Study groups in NCT04321616
Study groupRoleWhat they receive
HydroxychloroquineActive comparatorNot described
Receives: Drug: Remdesivir; Other: (Standard of Care) SoC
RemdesivirActive comparatorNot described
Receives: Drug: Hydroxychloroquine; Other: (Standard of Care) SoC
Control group - SoCActive comparatorNot described
Receives: Drug: Hydroxychloroquine; Drug: Remdesivir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital mortality

    All cause in-hospital mortality

    Measured: 3 weeks

Secondary outcomes (7)

  1. Occurrence and duration of mechanical ventilation

    Measured: 3 weeks

  2. Occurrence and duration of intensive care unit (ICU) treatment

    Measured: 3 weeks

  3. Duration of hospital admittance

    Measured: 1 month

  4. 28 Day mortality

    Measured: 3 weeks

  5. Viral clearance as assessed by SARS-CoV-2 PCR in peripheral blood and nasopharyngeal airway speciemen

    Measured: 3 weeks

  6. Occurrence of co-infections

    Measured: 3 weeks

  7. Occurrence of organ dysfunction

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start28 Mar 2020
  3. Primary completionAug 2020 (estimated)
  4. Study completionNov 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
An open randomized adaptive controlled trial
Masking
None (open label)
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04321616
Sponsor's protocol ID
118684
Status last verified
Apr 2020
First submitted
23 Mar 2020
Last updated
14 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All patients included in this study will automatically be included in the WHO COVID 19 protocol

Publications

  • Patrick-Brown TDJH, Barratt-Due A, Troseid M, Dyrhol-Riise AM, Nezvalova-Henriksen K, Kasine T, Aukrust P, Olsen IC; NOR Solidarity consortium. The effects of remdesivir on long-term symptoms in patients hospitalised for COVID-19: a pre-specified exploratory analysis. Commun Med (Lond). 2024 Nov 12;4(1):231. doi: 10.1038/s43856-024-00650-4.

    PubMed 39533001

  • Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.

    PubMed 36695483

  • Tveita A, Murphy SL, Holter JC, Kildal AB, Michelsen AE, Lerum TV, Kaarbo M, Heggelund L, Holten AR, Finbraten AK, Muller KE, Mathiessen A, Boe S, Fevang B, Granerud BK, Tonby K, Lind A, Dudman SG, Henriksen KN, Muller F, Skjonsberg OH, Troseid M, Barratt-Due A, Dyrhol-Riise AM, Aukrust P, Halvorsen B, Dahl TB, Ueland T; NOR-SOLIDARITY Consortium and the Norwegian SARS-CoV-2 Study Group Investigators. High Circulating Levels of the Homeostatic Chemokines CCL19 and CCL21 Predict Mortality and Disease Severity in COVID-19. J Infect Dis. 2022 Dec 13;226(12):2150-2160. doi: 10.1093/infdis/jiac313.

    PubMed 35876699

  • Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.

    PubMed 34350582

  • Barratt-Due A, Olsen IC, Nezvalova-Henriksen K, Kasine T, Lund-Johansen F, Hoel H, Holten AR, Tveita A, Mathiessen A, Haugli M, Eiken R, Kildal AB, Berg A, Johannessen A, Heggelund L, Dahl TB, Skara KH, Mielnik P, Le LAK, Thoresen L, Ernst G, Hoff DAL, Skudal H, Kittang BR, Olsen RB, Tholin B, Ystrom CM, Skei NV, Tran T, Dudman S, Andersen JT, Hannula R, Dalgard O, Finbraten AK, Tonby K, Blomberg B, Aballi S, Fladeby C, Steffensen A, Muller F, Dyrhol-Riise AM, Troseid M, Aukrust P; NOR-Solidarity trial. Evaluation of the Effects of Remdesivir and Hydroxychloroquine on Viral Clearance in COVID-19 : A Randomized Trial. Ann Intern Med. 2021 Sep;174(9):1261-1269. doi: 10.7326/M21-0653. Epub 2021 Jul 13.

    PubMed 34251903

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Hydroxychloroquine and Remdesivir in people with SARS-CoV Infection and COVID 19, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Paul Aukrust, MD, Professor (0047 46778374, paukrust@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital mortality (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321616, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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