600
Participants
Start Date
July 3, 2020
Primary Completion Date
October 31, 2026
Study Completion Date
October 31, 2026
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."
CST-2: Placebo
CST-2 Phase II: Placebo will be administered orally, twice daily (BID) for 10 doses (5 or 6 days).
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."
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."
VIR-7831
CST-5 Phase II: A 500 mg dose of VIR-7831 will also be given by IV infusion over 1 hour.
CST-5: Placebo
CST-5 Phase 1, Phase II: Placebo given by intravenous infusion over 1 hour
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).
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.
Paxlovid
Paxlovid® (300mg nirmatrelvir + ritonavir 100mg) twice a day (BD) for 5 days. The dose of Paxlovid® will be fixed for all cohorts.
ALG-097558
ALG-097558 600 mg Twice a day (BD) for 5 days
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.
NHS standard of care as per COVID-19 treatment guidelines
NHS standard of care as per COVID-19 treatment guidelines
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
RECRUITING
Liverpool University Hospitals NHS Foundation Trust, Liverpool
ACTIVE_NOT_RECRUITING
University Hospital Southampton NHS Foundation Trust, Southampton
Liverpool School of Tropical Medicine
OTHER
Royal Liverpool University Hospital
OTHER_GOV
University of Cambridge
OTHER
University of Liverpool
OTHER