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

COVID-19 Clinical Trial

Official title: Industry Alliance Platform Trial to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

This adaptive, randomized, placebo-controlled platform study is designed to rapidly assess multiple candidate agents as treatments for COVID-19 in hospitalized patients. Candidate agents will be evaluated frequently (through ongoing monitoring) for futility 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.

For inclusion, participants will need to be hospitalized with a clinical status of Grade 2 to Grade 5, as defined by the following Clinical Severity Status 8-Point Ordinal Scale:

1. Death

2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

3. Hospitalized, on noninvasive ventilation or high-flow oxygen devices

4. Hospitalized, requiring supplemental oxygen

5. Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise)

6. Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care

7. Not hospitalized, limitation on activities and/or requiring home oxygen

8. Not hospitalized, no limitations on activities

Participants will be randomized equally to either the candidate agent plus standard of care (SoC) or placebo plus SoC in a double-blind fashion. Participants who are randomized to placebo plus SoC will subsequently be randomized equally to a matching placebo corresponding to an available agent whose sub-protocol the patient qualified for (ie, a 2-stage randomization). Each participant in the placebo plus SoC group will only receive one type of placebo. Randomization will be stratified by baseline clinical severity of 2 on the 8-point ordinal scale (yes/no) and remdesivir use at baseline (yes/no).

The study will evaluate each candidate agent separately as an add-on to the SoC to assess safety and efficacy. The comparator group for a candidate agent will include participants randomized to the placebo arm of any sub-protocol according to the following conditions:

• Apremilast sub-protocol: participants who were enrolled concurrently to apremilast and who would have been eligible for the apremilast sub-protocol.

• Lanadelumab sub-protocol: at a site where at least one participant was randomized to either lanadelumab active or placebo arms.

• Zilucoplan sub-protocol: at a site where at least one participant was randomized to either the zilucoplan active or placebo arms. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04590586
• Study type: Interventional
• Source: Amgen
• Status: Completed
• Phase: Phase 3
• Start date: November 24, 2020
• Completion date: August 3, 2021