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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04445467
Registration number
NCT04445467
Ethics application status
Date submitted
22/06/2020
Date registered
24/06/2020
Titles & IDs
Public title
An Adaptive Clinical Trial of Antivirals for COVID-19 Infection
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Scientific title
An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection
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Secondary ID [1]
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66223
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Universal Trial Number (UTN)
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Trial acronym
VIRCO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Favipiravir
Experimental: Favipiravir - 1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.
Placebo comparator: Placebo - Matched Placebo
Treatment: Drugs: Favipiravir
Favipiravir
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to virological cure
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Assessment method [1]
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Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing
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Timepoint [1]
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14 days
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Secondary outcome [1]
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Safety
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Assessment method [1]
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All adverse events definitely, probably or possibly related to study treatment.
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Timepoint [1]
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28 days
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Secondary outcome [2]
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Clinical improvement
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Assessment method [2]
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Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale
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Timepoint [2]
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28 days
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Secondary outcome [3]
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Clinical symptoms
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Assessment method [3]
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Time from randomization to resolution of clinical symptoms (fever, cough, shortness of breath, cough). Resolution defined as the start of the first 24 hour period when all symptoms are rated as mild or absent and remained this way for 24 hours
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Timepoint [3]
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28 days
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Secondary outcome [4]
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Biomarkers
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Assessment method [4]
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Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.
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Timepoint [4]
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28 days
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Eligibility
Key inclusion criteria
* Provision of informed consent by the participant or authorized representative
* Age =18 years
* Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days
* COVID-19 related symptom initiation within 5 days
* Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known allergy to the study medication
* Is on another antiviral for the treatment of COVID-19
* Pregnancy
* Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification
* Patients with renal impairment requiring dialysis
* Is deemed by the Investigator to be ineligible for any reason
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2021
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Actual
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Sample size
Target
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Accrual to date
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Final
190
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a randomised placebo controlled phase II trial to examine the efficacy of antivirals to treat COVID-19 infection compared to placebo for virological cure and improved clinical outcomes. Individuals will be randomised to the candidate antiviral which in the first instance is Favipiravir or matched placebo and randomisation will be stratified according to whether the participant requires hospitalisation or not. This treatment will be given in addition to the usual standard of care in the participating hospital.
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Trial website
https://clinicaltrials.gov/study/NCT04445467
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Trial related presentations / publications
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. McMahon JH, Lau JSY, Roney J, Rogers BA, Trubiano J, Sasadeusz J, Molton JS, Gardiner B, Lee SJ, Hoy JF, Cheng A, Peleg AY. An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 13;21(1):847. doi: 10.1186/s13063-020-04766-5.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04445467