An Adaptive Clinical Trial of Antivirals for COVID-19 Infection

COVID Clinical Trial

— VIRCO  

Official title:

An Adaptive Randomised Placebo Controlled Phase II Trial of Antivirals for COVID-19 Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04445467
• Other study ID #: 66223
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 30, 2020
• Est. completion date: December 2021

Study information

• Verified date: October 2021
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• COVID
• COVID-19

Intervention

Drug:
• Favipiravir
Favipiravir

Locations

Country	Name	City	State
Australia	Alfred Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to virological cure	Time to 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing	14 days
Secondary	Safety	All adverse events definitely, probably or possibly related to study treatment.	28 days
Secondary	Clinical improvement	Time from randomization to an improvement of two points (from the status at randomization) on the 7-point ordinal scale	28 days
Secondary	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	28 days
Secondary	Biomarkers	Biomarkers taken as part of routine care including total lymphocyte count, CRP, Ferritin and LDH.	28 days