CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 515 enrolled
Drug / intervention
Standard of care +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04590586
NCT04590586Phase 3Completed

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

Amgen·interventional·Posted Oct 19, 2020·Updated Jun 29, 2022

In Brief

A Phase 3 clinical trial evaluating Standard of care, Apremilast, and 5 other interventions for COVID-19. Completed, enrolled 515 participants across 59 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesArgentina, Brazil, Chile, Mexico, Russia, South Africa, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedOct 19, 2020
Enrollment StartNov 24, 2020
Primary CompletionAug 3, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.7 years ago

Interventions

Standard of caredrug

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.

Apremilastdrug

Apremilast administered orally as a tablet.

Apremilast placebodrug

Matching apremilast placebo administered orally as a tablet.

Lanadelumabdrug

Lanadelumab administered as an intravenous (IV) infusion.

Lanadelumab placebodrug

Matching lanadelumab placebo (normal saline) administered as an intravenous (IV) infusion.

Zilucoplandrug

Zilucoplan administered as a subcutaneous (sc) injection in the abdomen, thigh, or upper arm.

Zilucoplan placebodrug

Matching zilucoplan placebo administered as a subcutaneous (sc) injection in the abdomen, thigh, or upper arm.