Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients

Conditions

• COVID-19

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard of care — DRUG
  Standard of care (SoC) treatment for COVID-19 infection in line with institutional practice. The SoC may change as new information becomes available about treating COVID-19.
• Apremilast — DRUG
  Apremilast administered orally as a tablet.
• Apremilast placebo — DRUG
  Matching apremilast placebo administered orally as a tablet.
• Lanadelumab — DRUG
  Lanadelumab administered as an intravenous (IV) infusion.
• Lanadelumab placebo — DRUG
  Matching lanadelumab placebo (normal saline) administered as an intravenous (IV) infusion.
• Zilucoplan — DRUG
  Zilucoplan administered as a subcutaneous (sc) injection in the abdomen, thigh, or upper arm.
• Zilucoplan placebo — DRUG
  Matching zilucoplan placebo administered as a subcutaneous (sc) injection in the abdomen, thigh, or upper arm.

Study Details

The primary objective of this study is to evaluate the time to confirmed clinical recovery in participants hospitalized with COVID-19. Candidate agents will be evaluated frequently for efficacy and safety, with candidate agents being added to and/or removed from the study on an ongoing basis, depending on the results of their evaluation.

Key Dates

First listed

Oct 19, 2020

Start date

Nov 24, 2020

Status verified

Jun 2022

Primary completion

Aug 3, 2021

Completion

Aug 3, 2021

Study Design

Enrollment

515 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apremilast + Standard of Care
  Participants will be randomized to receive 30 mg apremilast orally twice a day (BID) in addition to standard of care treatment for 14 days or until hospital discharge, death, or discontinuation of investigational product, whichever occurred first.
• Placebo Comparator: Apremilast Placebo + Standard of Care
  Participants will be randomized to receive matching placebo to apremilast orally twice a day in addition to standard of care treatment for 14 days or until hospital discharge, death, or discontinuation of investigational product, whichever occurred first.
• Experimental: Lanadelumab + Standard of Care
  Participants will be randomized to receive lanadelumab 300 mg by intravenous infusion on Day 1, and a second dose administered on Day 4 in addition to standard of care.
• Placebo Comparator: Lanadelumab Placebo + Standard of Care
  Participants will be randomized to receive placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in addition to standard of care.
• Experimental: Zilucoplan + Standard of Care
  Participants will be randomized to receive 32.4 mg zilucoplan by subcutaneous injection every day for 14 days, or until discharge if discharge was before 14 days of treatment in addition to standard of care.
• Placebo Comparator: Zilucoplan Placebo + Standard of Care
  Participants will be randomized to receive placebo to zilucoplan by subcutaneous injection every day for 14 days, or until discharge if discharge was before 14 days of treatment in addition to standard of care.

Primary Outcome Measure

Lanadelumab Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29 [ Time Frame: Day 1 (the day of the first dose of study drug for randomized participants who received at least one dose of study drug or the day of randomization for randomized participants who did not receive any study drug) to Day 29 ]

Locations (21)

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