AGILE (Early Phase Platform Trial for COVID-19)

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.

Conditions

• Covid19

Interventions

DRUG

CST-2: EIDD-2801

CST-2 Phase Ib: EIDD-2801 will be administered orally, twice daily (BID) for 10 doses (5 or 6 days). The starting dose will be established based on safety and pharmacokinetics from the EIDD-2801-1001-US/UK study, and dose escalations may occur as described in this CST. Phase II: As per Phase Ib, with the dose determined by the recommended phase II dose.

DRUG

CST-2: Placebo

CST-2 Phase II: Placebo will be administered orally, twice daily (BID) for 10 doses (5 or 6 days).

DRUG

Nitazoxanide

CST3A \& CST3B Phase I: Nitazoxanide will be administered orally, initially twice daily (BID) for 14 doses (7 days). The starting dose will be 1500mg BID based on existing dose information, but dose adaptations may occur. Phase II: As per Phase Ib, with the dose determined by the recommended phase II dose.

DRUG

VIR-7832

CST-5: Phase I, Single doses of VIR-7832 will be administered by intravenous (IV) infusion over 1 hour. The starting dose will be 50 mg, and dose escalations of 150 and 500 mg are anticipated, with escalation guided by emerging safety data and decision by the SRC. Phase II: As per Phase I, with the dose determined by the recommended phase II dose.

DRUG

VIR-7831

CST-5 Phase II: A 500 mg dose of VIR-7831 will also be given by IV infusion over 1 hour.

DRUG

CST-5: Placebo

CST-5 Phase 1, Phase II: Placebo given by intravenous infusion over 1 hour

DRUG

Favipiravir

CST-6: Multiple doses of IV Favipiravir will be administered by intravenous (IV) infusion over 1 hour. Dosing regimen will be every 12 hours for 7 days duration. The starting dose will be 600mg (BID), and dose escalations to 1200mg (BID), 1800mg (BID) and 2400mg (BID) are anticipated as well as a de-escalation dose of 300mg (BID) if necessary, with de-escalation and escalation guided by emerging safety data and decision by the Safety Review Committee (SRC).

DRUG

Molnupiravir

Molnupiravir 800mg Twice a day (BD) for 5 days as starting dose, with a de-escalation protocol reducing in increments of molnupiravir to 600mg BD, then 400mg BD if required.

DRUG

Paxlovid

Paxlovid® (300mg nirmatrelvir + ritonavir 100mg) twice a day (BD) for 5 days. The dose of Paxlovid® will be fixed for all cohorts.

DRUG

ALG-097558

ALG-097558 600 mg Twice a day (BD) for 5 days

DRUG

ALG-097558 and Remdesivir

ALG-097558 600 mg Twice a day (BD) for 5 days Remdesivir will be administered once daily by intravenous infusion over 30 to 120 minutes. 200 mg will be given on day 1 and 100 mg on day 2 and day 3.

DRUG

NHS standard of care as per COVID-19 treatment guidelines

NHS standard of care as per COVID-19 treatment guidelines

DRUG

ALG-097558

twice daily (Q12H) oral dose of ALG-097558

DRUG

Placebo

twice daily (Q12H) oral dose

Sponsors & Collaborators

• Liverpool School of Tropical Medicine

  collaborator OTHER

• Royal Liverpool University Hospital

  collaborator OTHER_GOV

• University of Cambridge

  collaborator OTHER

• University of Liverpool

  lead OTHER

Principal Investigators

• Saye Khoo · University of Liverpool

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-03

Primary Completion

2026-07-31

Completion

2026-07-31

Countries

• South Africa
• United Kingdom

Study Locations