AGILE (Early Phase Platform Trial for COVID-19)
ConditionCovid19
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Liverpool
About this trial
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.
Eligibility criteria
Qualifiers
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
If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible.
Disqualifiers
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 m²)
Pregnant or breast feeding
Anticipated transfer to another hospital which is not a study site within 72 hours
Trial design
Treatments tested in this trial
- CST-2: EIDD-2801
- CST-2: Placebo
- Nitazoxanide
- VIR-7832
- VIR-7831
- CST-5: Placebo
- Favipiravir
- Molnupiravir
- Paxlovid
- ALG-097558
- ALG-097558 and Remdesivir
- NHS standard of care as per COVID-19 treatment guidelines
- ALG-097558
- Placebo
Treatment groups
600 Participants
are divided into 21 treatment groups21
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Liverpool
Lead sponsor
Liverpool School of Tropical Medicine
Collaborator
Royal Liverpool University Hospital
Collaborator
University of Cambridge
Collaborator
Source ClinicalTrials.gov