Agile CST-9b
Title
AGILE Platform; Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment
Candidate Specific Trial -9b (CST-9b): A Multicentre, Adaptive Phase II Randomised Double-Blind Placebo Controlled Trial to Evaluate the Safety, Efficacy and Virology Response of ALG-097558 for the Treatment of COVID-19 Disease.
Description
This is a double-blind 1:1 stratified randomised controlled adaptive trial with twice daily oral dose of ALG-097558 versus matching placebo to determine the safety and tolerability of ALG-097558 and change in viral titre overtime following administration of ALG-097558 versus placebo.
Objectives
Primary Objectives:
Phase 1:
Safety Objective: Determine the safety and tolerability of ALG-097558.
Efficacy Objective: Determine change in viral titre over time following administration of ALG-097558 versus placebo.
Secondary Objectives:
- To establish the pharmacokinetics of ALG-097558 in plasma
- To establish disease progression endpoints including visits to emergency department, hospitalisations, all- cause mortality
- To evaluate the incidence of rebound SARS-CoV-2 infection
- Viral dynamics in subgroup of participants with high baseline viral titre (defined as Ct value of <22)
- Viral dynamics in subgroup of participants randomised within 3 days of symptoms onset
- To determine time to sustained symptoms resolution following administration of ALG-097558 versus placebo defined as time from first dose to time when symptoms are first rated as absent for two consecutive visits on different calendar days.
Exploratory Objectives:
- To characterise pharmacokinetics of ALG-097558 in tears, saliva, and nasal secretions
- To characterise genetic variability in SARS-CoV-2 before and during treatment
- To characterise time dependent changes in host response to infection or drug exposure
Trial Design
Double Blind 1:1 stratified randomised controlled adaptive trial with twice daily (Q12H) oral dose of ALG-097558 versus matching placebo for ALG097558 with an early futility analysis. Participants will have mild-moderate SARS-CoV-2 infection and will not be considered to be at high risk for disease progression.
Trial Status
Open for recruitment.
Population
Adults (>/= 18 years of age with a positive SARS-CoV-2 lateral flow test, who are not at high risk of progressing to severe COVID-19 disease (as defined in UK DHSC criteria), within 5 days of symptom onset, with at least one symptom of COVID-19 infection present on the day of randomisation, and with mild- moderate disease severity at enrolment.A subgroup of participants randomized within 3 days of symptom onset will be evaluated in secondary analyses.
Trial Manager:
Jan Dixon
Programme Managers
Helen Reynolds
Michelle Tetlow
Justin Chiong
Data Manager
Michelle Stackpole
Trial Statistician
Jones Ashley
Contact Information
SAE reporting:
Press releases, video clips and other external websites
(University of Southampton cannot accept responsibility for external websites)
AGILE website (press section) – https://www.agiletrial.net/for-press/
Why is this trial being done
You have suspected or confirmed COVID-19, which is caused by the SARS-CoV-2 coronavirus.
The trial drug ALG-097558, is an experimental new medicine for treating COVID-19. This trial aims to assess whether it may be useful for patients with COVID-19. These treatments have been recommended for testing by a team of experts based on strict criteria.
What is the purpose of this trial?
The aims of this trial are to determine the following:
- The safety of the trial drug and any side effects that might be associated
- How much of the trial drug get into the bloodstream
- How quickly the body removes the trial drug
- How well the trial drug might be able to reduce complications of COVID-19
- How the trial drug affects the body’s response to COVID-19
- Any changes in the amount of virus present from the start of treatment
There is limited information on the trial drug ALG-097558 and its effectiveness in treating COVID-19. However, in a trial of ALG-097558 in heathy volunteers, ALG-097558 was tolerated well, with minimal side effects. Side effects are any unwanted, or sometimes unpleasant reactions that may result from taking a drug or having a procedure.
Design of the study:
This is a double blinded, randomised controlled trial. This means that you and your doctors will NOT know whether you are taking the study drug or a placebo. The trial compares the trial drug with a placebo treatment, which appears the same as the trial drug, but contains no active drug. The treatment group will receive the trial drug ALG-097558 alone. The control group will receive a placebo treatment. Whether you receive the trial drug will be determined by a process called randomisation. This means you will be randomly assigned to receive either the trial drug alone or placebo.
You will have a 1:1 chance of receiving any of the treatments. This means that for every 2 participants who enter the trial, 1 patient will receive the trial drug alone and 1 patient will receive placebo.
Trial drug alone (ALG-097558)
The trial drug ALG-097558 will be administered at a dose of 600 mg (6 x 100 mg tablets) twice a day (12 hours apart) for a total of 5 days of dosing (a total of 10 doses). The first dose will be taken in the clinic or while you are in hospital. The rest of the medication will be taken at home or in the hospital by yourself. You will be asked to record taking your doses in a dosing card.
Placebo
If you are randomised to the placebo arm, you will receive 600mg (6 x 100mg tablets) twice a day (12 hours apart) for a total of 5 days of dosing (a total of 10 doses). We will still follow you up regardless of which group you are in. This is so we can compare the results for all the treatments given.
What the trial involves:
The trial involves 5-6 visits to the Clinical Research Facility/ unit. If you are hospitalized when enrolled in the trial, some of the visits may take place during that time and follow-up visits will be continued after you are discharged. These visits will include the Screening visit, a baseline visit (Day 1, which may be combined with screening), and further clinic visits at Days 5, 8 and 11.
Are there any financial costs or payments?
You will be compensated £1020 for your time and inconvenience or £1170 if you provide pharmacokinetics samples. Travel expenses related to the trial will also be reimbursed. Please discuss any necessary travel arrangements with the trial team prior to the visit.
Further information:
Please contact your local team who can provide further information and a copy of the Participant Information Leaflet.