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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
Date last updated
7/10/2021

Titles & IDs
Public title
An Adaptive Clinical Trial of Antivirals for COVID-19 Infection
Scientific title
An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection
Secondary ID [1] 0 0
66223
Universal Trial Number (UTN)
Trial acronym
VIRCO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to virological cure
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Safety
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Clinical improvement
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Clinical symptoms
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Biomarkers
Timepoint [4] 0 0
28 days

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
Accrual to date
Final
190
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04445467
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04445467