South Africa, United Kingdom600 participantsStarted 2020-07-03
Plain-language summary
The AGILE platform master protocol allows incorporation of a range of identified and yet-to-be-identified candidates as potential treatments for adults with COVID-19 into the trial. Candidates will be added into the trial via candidate-specific trial (CST) protocols of this master protocol as appendices. Having one master protocol ensures different candidates are evaluated in the same consistent manor and opening up new trials for new candidates is more efficient. Inclusion of new candidates will be based on pre-clinical data, evidence in the clinical setting and GMP capabilities.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults (≥18 years) with laboratory-confirmed\* SARS-CoV-2 infection (PCR)
. Ability to provide informed consent signed by study patient or legally acceptable representative
. Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception (as outlined in the protocol) from the first administration of trial treatment, throughout trial treatment and for the duration outlined in the candidate-specific trial protocol after the last dose of trial treatment
. Group A (severe disease). Patients with clinical status of Grades 5 (hospitalised, oxygen by mask or nasal prongs), 6 (hospitalised, on non-invasive ventilation, or high flow oxygen as defined by the WHO Clinical Progression Scale (WHO, 2020)).
. Less than or equal to 14 days from onset of COVID-19 symptoms
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Master Protocol: Dose-finding/Phase I
Timeframe: 29 days from randomisation
2
Master Protocol: Efficacy evaluation/Phase II - Severe patients (Group A)
Timeframe: 29 days from randomisation
3
Master Protocol: Efficacy evaluation/Phase II - Mild to moderate patients (Group B)
Timeframe: 15 days from randomisation
4
CST-2 Phase I: To determine the safety and tolerability of multiple ascending doses of EIDD-2801 to recommend dose for phase II.
Timeframe: 7 days from randomisation
5
CST-2 Phase II: To determine the ability of EIDD-2801 to reduce serious complications of COVID-19 including hospitalization, reduction in SAO2<92%, or death.
Timeframe: 29 days from randomisation
6
CST6 Phase I: To determine the safety and tolerability of multiple doses of IV Favipiravir in patients with COVID-19
. For the purpose of CST-8, criteria 1 has been amended from the Master Protocol to:
. Criteria 3 has been amended from the Master Protocol to:
. Adults (\>/= 18 years of age) with a positive SARS-CoV-2 lateral flow test on screening or Day 1, who are at high risk (as defined in UK DHSC criteria) of progressing to severe COVID-19 disease, within 3 days of symptom onset, with at least one symptom of COVID-19 infection present on the day of randomization and are with mild- moderate disease severity at enrolment.
Exclusion criteria
. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>5 times the upper limit of normal (ULN)
. Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration rate \<30 mL/min/1.73 m\^2)
. Pregnant or breast feeding
. Anticipated transfer to another hospital which is not a study site within 72 hours
. Allergy to any study medication
. Patients taking other prohibited drugs (as outline in CST protocol) within 30 days or 5 times the half-life (whichever is longer) of enrolment
. Patients participating in another CTIMP trial
. Prior SARS-CoV-2 infection \<90 days before enrolment and/or received any COVID-19 vaccine dose \<90 days before enrolment
CST6 Phase I: To determine the maximum safe dose of IV Favipiravir for efficacy evaluation in phase II
Timeframe: 8 days from randomisation
8
CST-8 Phase I: Dose Limiting Toxicities up to and including Day 11
Timeframe: 11 days from randomisation
9
CST-9a: Dose limiting toxicities up to and including Day 11
Timeframe: 11 days from randomisation
10
CST-9a: to determine the safety and tolerability of ALG-097558 and ALG-097558 plus remdesivir combination
Timeframe: 11 days from randomisation
11
CST-9a: Change in viral titre overtime following administration of ALG-097558 alone and in combination with RDV versus Standard of Care (SoC)