AGILE (Early Phase Platform Trial for COVID-19)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

July 3, 2020

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

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

Trial Locations (6)

Unknown

COMPLETED

Desmond Tutu Health Foundation, Cape Town

COMPLETED

Ezintsha, Johannesburg

ACTIVE_NOT_RECRUITING

Kings College Hospital NHS Foundation Trust, London

ACTIVE_NOT_RECRUITING

Manchester University NHS Foundation Trust, Manchester

L7 8XP

RECRUITING

Liverpool University Hospitals NHS Foundation Trust, Liverpool

SO16 6YD

ACTIVE_NOT_RECRUITING

University Hospital Southampton NHS Foundation Trust, Southampton

All Listed Sponsors
collaborator

Liverpool School of Tropical Medicine

OTHER

collaborator

Royal Liverpool University Hospital

OTHER_GOV

collaborator

University of Cambridge

OTHER

lead

University of Liverpool

OTHER