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

NCT04590586 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2022-06-29

Study results available
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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.

Conditions

Interventions

DRUG

Standard of care

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.

DRUG

Apremilast

Apremilast administered orally as a tablet.

DRUG

Apremilast placebo

Matching apremilast placebo administered orally as a tablet.

DRUG

Lanadelumab

Lanadelumab administered as an intravenous (IV) infusion.

DRUG

Lanadelumab placebo

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

DRUG

Zilucoplan

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

DRUG

Zilucoplan placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2021-08-03
Completion
2021-08-03
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • Mexico
  • Russia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04590586 on ClinicalTrials.gov