NCT04316377

Brief Summary

In the current proposal, the investigators aim to investigate the virological and clinical effects of chloroquine treatment in patients with established COVID-19 in need of hospital admission. Patients will be randomized in a 1:1 fashion to standard of care or standard of care with the addition of therapy with chloroquine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 25, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2020

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

March 13, 2020

Last Update Submit

June 4, 2020

Conditions

Corona Virus Infection

Keywords

Corona virus infectionChloroquinePragmatic trial

Outcome Measures

Primary Outcomes (1)

  • Rate of decline in SARS-CoV-2 viral load

    Viral load assessed by real time polymerase chain reaction in oropharyngeal samples

    Baseline (at randomization) and at 96 hours

Secondary Outcomes (13)

  • Change in National Early Warning Score score

    Baseline (at randomization) and at 96 hours

  • Admission to intensive care unit

    At all times after randomization during index admission (between admission and discharge, approximately 21 days)

  • In-hospital mortality

    At all times after randomization during index admission (between admission and discharge, approximately 21 days)

  • Duration of hospital admission

    During index admission (between admission and discharge, approximately 21 days)

  • Mortality at 30 and 90 days

    At follow-up 30 and 90 days

  • +8 more secondary outcomes

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Chloroquine therapy in addition to standard of care

Drug: Hydroxychloroquine Sulfate

No Treatment

NO INTERVENTION

Standard of care

Interventions

Hydroxychloroquine SulfateDRUG

400 mg hydroxychloroquine sulphate (equalling 310 mg base) twice daily for seven days

Also known as: Plaquenil
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalised
  • Adults 18 year or older
  • Moderately severe disease (NEWS score ≤ 6)
  • SARS-CoV-2 positive nasopharyngeal swab
  • Expected time of admission \> 48 hours
  • Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations.

You may not qualify if:

  • Requiring ICU admission at screening
  • History of psoriasis
  • Known adverse reaction to hydroxychloroquine sulphate
  • Pregnancy
  • Prolonged QT interval (\>450 ms)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Related Publications (2)

  • Lyngbakken MN, Berdal JE, Eskesen A, Kvale D, Olsen IC, Rueegg CS, Rangberg A, Jonassen CM, Omland T, Rosjo H, Dalgard O. A pragmatic randomized controlled trial reports lack of efficacy of hydroxychloroquine on coronavirus disease 2019 viral kinetics. Nat Commun. 2020 Oct 20;11(1):5284. doi: 10.1038/s41467-020-19056-6.

    PMID: 33082342DERIVED

  • Lyngbakken MN, Berdal JE, Eskesen A, Kvale D, Olsen IC, Rangberg A, Jonassen CM, Omland T, Rosjo H, Dalgard O. Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 5;21(1):485. doi: 10.1186/s13063-020-04420-0.

    PMID: 32503662DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Olav Dalgard, MD PhD

    Akerhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm, open label, pragmatic randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 20, 2020

Study Start

March 25, 2020

Primary Completion

May 25, 2020

Study Completion

March 3, 2025

Last Updated

June 5, 2020

Record last verified: 2020-06

Locations

NO(1)