An Adaptive Clinical Trial of Antivirals for COVID-19 Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2021-12-31

Brief Summary

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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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Detailed Description

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Conditions

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COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Favipiravir

1800 mg Favipiravir twice daily on Day 1 followed by 800 mg Favipiravir twice daily for the next 13 days.

Group Type EXPERIMENTAL

Favipiravir

Intervention Type DRUG

Favipiravir

Placebo

Matched Placebo

Group Type PLACEBO_COMPARATOR

Favipiravir

Intervention Type DRUG

Favipiravir

Interventions

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Favipiravir

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No