Status:
UNKNOWN
An Adaptive Clinical Trial of Antivirals for COVID-19 Infection
Lead Sponsor:
Bayside Health
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Indivi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04445467
Start Date
July 30 2020
End Date
December 1 2021
Last Update
October 7 2021
Active Locations (1)
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1
Alfred Health
Melbourne, Victoria, Australia, 3004