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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04445467




Registration number
NCT04445467
Ethics application status
Date submitted
22/06/2020
Date registered
24/06/2020
Date last updated
19/08/2020

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

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 - Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Safety - All adverse events definitely, probably or possibly related to study treatment.
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Clinical improvement - Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Clinical symptoms - 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
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Biomarkers - Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Other
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/show/NCT04445467
Trial related presentations / publications
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
James McMahon
Address 0 0
Country 0 0
Phone 0 0
+61390766908
Fax 0 0
Email 0 0
james.mcmahon@monash.edu
Contact person for scientific queries

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