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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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 facts

Study ID: NCT04590586
Run by: Amgen
People needed: 515
Starts: 2020-11-24
Expected to finish: 2021-08-03
Last updated by the study team: 2022-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults (≥18 years of age) with active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by laboratory tests and/or point of care tests (eg, commercial or public health assay, which is approved for emergency use). If no diagnostic test results are available that have been obtained during the previous 72 hours, then a test should be performed as part of the screening assessment.
A score of Grade 2 (hospitalized, on invasive mechanical ventilation or ECMO), Grade 3 (hospitalized, on noninvasive ventilation or high-flow oxygen devices), Grade 4 (hospitalized, requiring supplemental oxygen), or Grade 5 (hospitalized, not requiring supplemental oxygen, requiring ongoing medical care [COVID-19 related or otherwise]), as defined by an 8 point ordinal scale.
Male participants:
A male participant must agree to use contraception during the treatment period and for at least 6 weeks after the last dose of study treatment and refrain from donating sperm during this period.
Female participants:
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
Not a woman of childbearing potential (WOCBP). OR
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 weeks after the last dose of study treatment.
Ability to provide informed consent signed by the study participant or legally authorized representative.
Ability and willingness to participate in telephone/telemedicine follow-up visits if needed.
Zilucoplan only: Antibiotic prophylaxis: all participants must be willing to take antibiotic prophylaxis concomitantly, starting with the first dose of zilucoplan or placebo.

You may not qualify if…

Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (eg, compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments (eg, participants unable to swallow study medication tablets).
Stage 4 severe chronic kidney disease or requiring dialysis.
Screening 12-lead electrocardiogram (ECG) with a measurable QTc interval according to Fridericia correction (QTcF) ≥ 500 ms.
Anticipated transfer to another hospital that is not a study center within 72 hours.
Participants who are currently pregnant or who are not willing to discontinue breastfeeding.
Participants participating in another clinical study of an investigational medicinal product or other unapproved (or investigational) treatment for COVID-19.
Active tuberculosis or a history of incompletely treated tuberculosis.
Active, uncontrolled systemic bacterial or fungal infection(s).
Apremilast only: Current treatment with apremilast, or another agent of similar mechanism of action, for any indication within 1 week prior to first dose of investigational product.
Apremilast only: Concurrent use at screening or randomization of cytochrome P450 (CYP)3A inducers (eg, rifampin, phenobarbital, carbamazepine) within 1 week prior to first dose of investigational product.
Apremilast only: Known hypersensitivity to apremilast or any excipients in formulation.
Lanadelumab only: Known or suspected hypersensitivity to lanadelumab or any of its excipients.
Lanadelumab only: Previous (within 3 months prior to baseline) or current use of immunomodulators (eg, methotrexate, azathioprine, 6-mercaptopurine, tumor necrosis factor [TNF] α inhibitor, Janus kinase [JAK] inhibitor, alpha-integrin inhibitor).
Lanadelumab only: Known or suspected venous thromboembolism.
Lanadelumab only: Previous (within 3 months [or 5 half-lives, whichever is greater] of screening) or current use of plasma kallikrein (pKal) inhibitor or bradykinin receptor blocker.
Zilucoplan only: Participants with unresolved or suspected infection with Neisseria meningitidis or a past history of N. meningitidis (eg, in a complement-deficient patient).

Where it is running

Good Samaritan Hospital — Bakersfield, California, United States
Sharp Chula Vista Medical Center — Chula Vista, California, United States
El Centro Regional Medical Center — El Centro, California, United States
University of California Irvine Medical Center — Orange, California, United States
Riverside Community Hospital — Riverside, California, United States
University of California Davis Health System — Sacramento, California, United States
National Institute of Clinical Research — South El Monte, California, United States
UF Health Shands Hospital — Gainesville, Florida, United States
Memorial Hospital Jacksonville — Jacksonville, Florida, United States
Grady Health System — Atlanta, Georgia, United States
Great Lakes Clinical Trials — Chicago, Illinois, United States
The University of Iowa — Iowa City, Iowa, United States
Harper University Hospital — Detroit, Michigan, United States
Sinai Grace Hospital — Detroit, Michigan, United States
Detroit Receiving Hospital — Royal Oak, Michigan, United States
University of Tennessee Health Sciences Center — Memphis, Tennessee, United States
Medical City Ft. Worth — Fort Worth, Texas, United States
University of Texas Health Science Center at Houston — Houston, Texas, United States
Texoma Medical Center — Sherman, Texas, United States
MultiCare Health System Institute for Research and Innovation — Tacoma, Washington, United States
Hospital San Juan de Dios — Ramos Mejía, Buenos Aires, Argentina
Hospital General de Agudos Dr. J. M. Ramos Mejia — Ciudad Autonoma Buenos Aires, Argentina
Hospital General de Agudos Dr. Ignacio Pirovano — Ciudad Autonoma Buenos Aires, Argentina
Clinica Adventista Belgrano — Ciudad Autonoma Buenos Aires, Argentina
Pinnacle Research Group LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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