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 range18 Years
SexALL
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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
✓. 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)
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
Timeframe: 29 days from randomisation
7
CST6 Phase I: To determine the maximum safe dose of IV Favipiravir for efficacy evaluation in phase II