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

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Standard of care

Apremilast

Apremilast placebo

Lanadelumab

Lanadelumab placebo

Zilucoplan

Zilucoplan placebo

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Sites / Locations

Pinnacle Research Group LLC
Good Samaritan Hospital
Sharp Chula Vista Medical Center
El Centro Regional Medical Center
University of California Irvine Medical Center
Riverside Community Hospital
National Institute of Clinical Research
University of California Davis Health System
UF Health Shands Hospital
Memorial Hospital Jacksonville
Grady Health System
Great Lakes Clinical Trials
The University of Iowa
Harper University Hospital
Sinai Grace Hospital
Detroit Receiving Hospital
University of Tennessee Health Sciences Center
Medical City Ft. Worth
University of Texas Health Science Center at Houston
Texoma Medical Center
MultiCare Health System Institute for Research and Innovation
Hospital San Juan de Dios
Hospital General de Agudos Dr. J. M. Ramos Mejia
Hospital General de Agudos Dr. Ignacio Pirovano
Clinica Adventista Belgrano
Hospital Italiano de Rosario
Chronos Pesquisa Clinica
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Santa Casa de Misericórdia de Belo Horizonte
Hospital de Clínicas de Porto Alegre
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Praxis Pesquisa Médica
Hospital Base Osorno
Hospital General de Tijuana
Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Hospital Civil de Culiacan
TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich
SBIH of Moscow "Infectious Clinical Hospital # 1 of Department of Healthcare of Moscow"
SPb SBIH "Alexandrovskaya City Hospital"
St-George Hospital
SPb SBIH "Nikolaevskaya Hospital"
SPb SBIH "City Pokrovskaya Hospital"
SPb SBIH "City Hospital # 40 of Kurortnyi region"
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Johese Clinical Research: Unitas
MERC SiReN
Drs Sarvan and Moodley
Tread Research
Tiervlei Trial Centre
2 Military Hospital Internal Medicine
Dr JM Engelbrecht Trial Site
Clinical Projects Research SA (PTY) LTD
Communal Noncommercial Profit "Clinical City Hospital 16 of Dnipro Regional Council"
CNE of Kharkov RC Reg Cl Infectious Hospital
Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1"
City Clinical infectious Hospital
Municipal Non-Profit Enterprise Central City Hospital Of Rivne City Council
CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Apremilast + Standard of Care

Apremilast Placebo + Standard of Care

Lanadelumab + Standard of Care

Lanadelumab Placebo + Standard of Care

Zilucoplan + Standard of Care

Zilucoplan Placebo + Standard of Care

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Lanadelumab Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29

Confirmed clinical recovery means the participant is fit for discharge from hospital, defined by achieving a score of 6 (hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care), 7 (not hospitalized, limitation on activities and/or requiring home oxygen), or 8 (not hospitalized, no limitations on activities) on the clinical severity status 8-point ordinal scale, without being re-hospitalized prior to Day 29. The Kaplan-Meier estimate of the time to confirmed clinical recovery through Day 29, without re-hospitalization through Day 29, was calculated from Study Day 1 to the earliest date on which the participant had a score of 6, 7, or 8 up to Day 29. Participants who never reached a score of 6, 7, or 8 on the clinical severity status 8-point ordinal scale before or on Day 29 were censored at Day 29. Participants who discontinued from the study before or on Day 29 were censored at time of discontinuation from study.

Apremilast Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29

Zilucoplan Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29

Secondary Outcome Measures

Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29

Oxygen-free recovery at Day 29 is defined as being alive, discharged, and not receiving supplemental oxygen at Day 29. Participants who reached a score of 7 on the ordinal scale for clinical severity who were discharged to hospice care before or on Day 29 were considered as not discharged at Day 29. Participants with a missing oxygen-free recovery status at Day 29 were considered as not having an oxygen-free recovery.

Lanadelumab Sub-protocol: Percentage of Participants With a ≥ 2-point Improvement From Baseline or Fit for Discharge on the Clinical Severity Status 8-Point Ordinal Scale at Day 29

Fit for discharge is defined as achieving a score of 6, 7, or 8 on the clinical severity status 8-point ordinal scale. Participants with an ordinal scale score of 7 must not have been discharged to hospice care to be considered as fit for discharge. Participants with a missing clinical severity score at Day 29 were considered as not having met the event at Day 29. The clinical severity status 8-point ordinal scale scores are: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on noninvasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Lanadelumab Sub-protocol: Percentage of Participants Who Died Before or on Day 29

All-cause mortality is death due to any cause. Participants with an unknown alive/death status on Day 29 were considered alive for this analysis, with the exception of patients with a score of 7 who were discharged to hospice care before or on Day 29.

Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29

The clinical severity status 8-point ordinal scale scores are: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on noninvasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities Participants with a score of 7 who were discharged to hospice care are counted with participants with a score of 1 (death) for this endpoint.

Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29

The worst post-baseline score (lower scores are worse) through Day 29 in the clinical severity status 8-point ordinal scale, derived from all scores recorded after baseline up to and including Day 29. Participants with a score of 7 discharged to hospice care are considered as having a score of 1 (death) instead of a score of 7 for this endpoint. The clinical severity status 8-point ordinal scale scores are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on noninvasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29

Number of ICU days is the sum of the duration of any episode of ICU admission between Day 1 and Day 29, both inclusive. The number of ICU days of participants who died before or on Day 29 as well as of participants with a score of 7 on the clinical severity status 8-point ordinal scale who were discharged to hospice care by Day 29 was set to 30 (worst possible outcome).

Lanadelumab Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29

Number of invasive mechanical ventilator days is the sum of the duration of any episode of invasive mechanical ventilator admission between Day 1 and Day 29, both inclusive. The number of invasive mechanical ventilator days of participants who died before or on Day 29 as well as of participants with a score of 7 on the clinical severity status 8-point ordinal scale who were discharged to hospice care by Day 29 was set to 30.

Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Clinical Recovery by Days 8, 15, and 29

Clinical recovery is defined as being fit for discharge, i.e., the achievement of a score of 6, 7, or 8 on the clinical severity status 8-point ordinal scale. Participants with a score of 7 discharged to hospice care were not considered fit for discharge. Participants who discontinued the study on or before Days 8, 15, or 29 or with a missing clinical recovery status were considered as not having clinical recovery at each respective time point. Clinical severity status 8-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on noninvasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Sustained Clinical Recovery

Sustained clinical recovery is defined as being fit for discharge (achieving a score of 6, 7, or 8 on the clinical severity status 8-point ordinal scale) by Day 29, without re-hospitalization by Day 60. Participants with a score of 7 discharged to hospice care were not considered fit for discharge. Participants who died or discontinued from study or with a missing clinical recovery status at Day 60 were not considered having sustained clinical recovery. Clinical severity status 8-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on noninvasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Lanadelumab Sub-protocol: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to study treatment. A TEAE is an AE that occurs after the first dose of study drug. A Serious AE is any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, resulted in persistent disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may jeopardize the patient or require intervention to prevent an outcome listed above. The Investigator assessed the intensity of each AE according to the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1 Mild; asymptomatic or mild symptoms; Grade 2 Moderate; minimal, local or noninvasive intervention indicated; Grade 3 Severe or medically significant, not immediately life-threatening; Grade 4 Life-threatening; urgent intervention indicated; Grade 5 Death due to AE.

Apremilast Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29

Apremilast Sub-protocol: Percentage of Participants With a ≥ 2-point Improvement From Baseline or Fit for Discharge on the Clinical Severity Status 8-Point Ordinal Scale at Day 29

Fit for discharge is defined as achieving a score of 6, 7, or 8 on the clinical severity status 8-point ordinal scale. Participants with an ordinal scale score of 7 must not have been discharged to hospice care to be considered as fit for discharge. Participants with a missing clinical severity score at Day 29 were considered as not having met the event at Day 29. The clinical severity status 8-point ordinal scale scores are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on noninvasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Apremilast Sub-protocol: Percentage of Participants Who Died Before or on Day 29

Apremilast Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29

Apremilast Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-Point Ordinal Scale From Baseline to Day 29

The worst post-baseline score (lower scores are worse) through Day 29 in the clinical severity status 8-point ordinal scale, derived from all scores recorded after baseline up to and including Day 29. Participants with a score of 7 discharged to hospice care are considered as having a score of 1 (death) instead of a score of 7 for this endpoint. The clinical severity status 8-point ordinal scale scores are: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on noninvasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Apremilast Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29

Apremilast Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29

Apremilast Sub-protocol: Percentage of Participants Who Achieved Clinical Recovery at Days 8, 15, and 29

Apremilast Sub-protocol: Percentage of Participants Who Achieved Sustained Clinical Recovery

Apremilast Sub-protocol: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to study treatment. A TEAE is an AE that occurs after the first dose of study drug. A serious AE is any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, resulted in persistent disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may jeopardize the patient or require intervention to prevent an outcome listed above. The Investigator assessed the intensity of each AE according to the CTCAE grades: Grade 1 Mild; asymptomatic or mild symptoms; Grade 2 Moderate; minimal, local or noninvasive intervention indicated; Grade 3 Severe or medically significant, not immediately life-threatening; Grade 4 Life-threatening; urgent intervention indicated; Grade 5 Death due to AE.

Zilucoplan Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29

Zilucoplan Sub-protocol: Percentage of Participants With a ≥ 2-point Improvement From Baseline or Fit for Discharge on the Clinical Severity Status 8-Point Ordinal Scale at Day 29

Fit for discharge is defined as achieving a score of 6, 7, or 8 on the clinical severity status 8-point ordinal scale. Participants with an ordinal scale score of 7 must not have been discharged to hospice care to be considered as fit for discharge. Participants with a missing clinical severity score at Day 29 were considered as not having met the event at Day 29. The clinical severity status 8-point ordinal scale scores are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on noninvasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Zilucoplan Sub-protocol: Percentage of Participants Who Died Before or on Day 29

Zilucoplan Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29

The clinical severity status 8-point ordinal scale scores are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on noninvasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities Participants with a score of 7 who were discharged to hospice care are counted with participants with a score of 1 (death) for this endpoint.

Zilucoplan Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-Point Ordinal Scale From Baseline to Day 29

The worst post-baseline score (lower scores are worse) through Day 29 in the clinical severity status 8-point ordinal scale scores, derived from all scores recorded after baseline up to and including Day 29. Participants with a score of 7 discharged to hospice care were considered as having a score of 1 (death) instead of a score of 7 for this endpoint. The clinical severity status 8-point ordinal scale scores scores are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on noninvasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Zilucoplan Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29

Zilucoplan Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29

Zilucoplan Sub-protocol: Percentage of Participants Who Achieved Clinical Recovery by Days 8, 15, and 29

Zilucoplan Sub-protocol: Percentage of Participants Who Achieved Sustained Clinical Recovery

Zilucoplan Sub-protocol: Number of Participants With Treatment-emergent Adverse Events

An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to study treatment. A TEAE is an AE that occurs after the first dose of study drug. A serious AE is any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, resulted in persistent disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may jeopardize the patient or require intervention to prevent an outcome listed above. The Investigator assessed the intensity of each AE according to the CTCAE grades: Grade 1 Mild; asymptomatic or mild symptoms; Grade 2 Moderate; minimal, local or noninvasive intervention indicated; Grade 3 Severe or medically significant, not immediately life-threatening; Grade 4 Life-threatening; urgent intervention indicated; Grade 5 Death due to AE.

Full Information

NCT ID

NCT04590586

First Posted

October 14, 2020

Last Updated

June 23, 2022

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT04590586

Brief Title

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

Acronym

COMMUNITY

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

November 24, 2020 (Actual)

Primary Completion Date

August 3, 2021 (Actual)

Study Completion Date

August 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on noninvasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

515 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apremilast + Standard of Care

Arm Type

Experimental

Arm Description

Arm Title

Apremilast Placebo + Standard of Care

Arm Type

Placebo Comparator

Arm Description

Arm Title

Lanadelumab + Standard of Care

Arm Type

Experimental

Arm Description

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.

Arm Title

Lanadelumab Placebo + Standard of Care

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Zilucoplan + Standard of Care

Arm Type

Experimental

Arm Description

Arm Title

Zilucoplan Placebo + Standard of Care

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Standard of care

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Apremilast

Other Intervention Name(s)

Otezla

Intervention Description

Apremilast administered orally as a tablet.

Intervention Type

Drug

Intervention Name(s)

Apremilast placebo

Intervention Description

Matching apremilast placebo administered orally as a tablet.

Intervention Type

Drug

Intervention Name(s)

Lanadelumab

Other Intervention Name(s)

TAKHZYRO™, TAK-743

Intervention Description

Lanadelumab administered as an intravenous (IV) infusion.

Intervention Type

Drug

Intervention Name(s)

Lanadelumab placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Zilucoplan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Zilucoplan placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Lanadelumab Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29

Description

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

Title

Apremilast Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29

Description

Time Frame

Title

Zilucoplan Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29

Description

Time Frame

Secondary Outcome Measure Information:

Title

Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29

Description

Time Frame

Day 29

Title

Lanadelumab Sub-protocol: Percentage of Participants With a ≥ 2-point Improvement From Baseline or Fit for Discharge on the Clinical Severity Status 8-Point Ordinal Scale at Day 29

Description

Time Frame

Baseline (Day 1) and Day 29

Title

Lanadelumab Sub-protocol: Percentage of Participants Who Died Before or on Day 29

Description

Time Frame

Day 1 to Day 29

Title

Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29

Description

Time Frame

Day 8, Day 15, and Day 29

Title

Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29

Description

Time Frame

Day 2 to Day 29

Title

Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29

Description

Time Frame

Day 1 to Day 29

Title

Lanadelumab Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29

Description

Time Frame

Day 1 to Day 29

Title

Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Clinical Recovery by Days 8, 15, and 29

Description

Time Frame

Day 8, Day 15, and Day 29

Title

Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Sustained Clinical Recovery

Description

Time Frame

Day 60

Title

Lanadelumab Sub-protocol: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

From first dose of study drug to end of study (Day 60)

Title

Apremilast Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29

Description

Time Frame

Day 29

Title

Apremilast Sub-protocol: Percentage of Participants With a ≥ 2-point Improvement From Baseline or Fit for Discharge on the Clinical Severity Status 8-Point Ordinal Scale at Day 29

Description

Fit for discharge is defined as achieving a score of 6, 7, or 8 on the clinical severity status 8-point ordinal scale. Participants with an ordinal scale score of 7 must not have been discharged to hospice care to be considered as fit for discharge. Participants with a missing clinical severity score at Day 29 were considered as not having met the event at Day 29. The clinical severity status 8-point ordinal scale scores are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on noninvasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Time Frame

Baseline (Day 1) and Day 29

Title

Apremilast Sub-protocol: Percentage of Participants Who Died Before or on Day 29

Description

Time Frame

Day 1 to Day 29

Title

Apremilast Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29

Description

Time Frame

Day 8, Day 15, and Day 29

Title

Apremilast Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-Point Ordinal Scale From Baseline to Day 29

Description

The worst post-baseline score (lower scores are worse) through Day 29 in the clinical severity status 8-point ordinal scale, derived from all scores recorded after baseline up to and including Day 29. Participants with a score of 7 discharged to hospice care are considered as having a score of 1 (death) instead of a score of 7 for this endpoint. The clinical severity status 8-point ordinal scale scores are: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on noninvasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Time Frame

Day 2 to Day 29

Title

Apremilast Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29

Description

Time Frame

Day 1 to Day 29

Title

Apremilast Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29

Description

Time Frame

Day 1 to Day 29

Title

Apremilast Sub-protocol: Percentage of Participants Who Achieved Clinical Recovery at Days 8, 15, and 29

Description

Time Frame

Day 8, Day 15, and Day 29

Title

Apremilast Sub-protocol: Percentage of Participants Who Achieved Sustained Clinical Recovery

Description

Time Frame

Day 60

Title

Apremilast Sub-protocol: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to study treatment. A TEAE is an AE that occurs after the first dose of study drug. A serious AE is any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, resulted in persistent disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may jeopardize the patient or require intervention to prevent an outcome listed above. The Investigator assessed the intensity of each AE according to the CTCAE grades: Grade 1 Mild; asymptomatic or mild symptoms; Grade 2 Moderate; minimal, local or noninvasive intervention indicated; Grade 3 Severe or medically significant, not immediately life-threatening; Grade 4 Life-threatening; urgent intervention indicated; Grade 5 Death due to AE.

Time Frame

From first dose of study drug to end of study (Day 60)

Title

Zilucoplan Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29

Description

Time Frame

Day 29

Title

Zilucoplan Sub-protocol: Percentage of Participants With a ≥ 2-point Improvement From Baseline or Fit for Discharge on the Clinical Severity Status 8-Point Ordinal Scale at Day 29

Description

Fit for discharge is defined as achieving a score of 6, 7, or 8 on the clinical severity status 8-point ordinal scale. Participants with an ordinal scale score of 7 must not have been discharged to hospice care to be considered as fit for discharge. Participants with a missing clinical severity score at Day 29 were considered as not having met the event at Day 29. The clinical severity status 8-point ordinal scale scores are: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on noninvasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care Not hospitalized, limitation on activities and/or requiring home oxygen Not hospitalized, no limitations on activities

Time Frame

Baseline (Day 1) and Day 29

Title

Zilucoplan Sub-protocol: Percentage of Participants Who Died Before or on Day 29

Description

Time Frame

Day 1 to Day 29

Title

Zilucoplan Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29

Description

Time Frame

Day 8, Day 15, and Day 29

Title

Zilucoplan Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-Point Ordinal Scale From Baseline to Day 29

Description

Time Frame

Day 2 to Day 29

Title

Zilucoplan Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29

Description

Time Frame

Day 1 to Day 29

Title

Zilucoplan Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29

Description

Time Frame

Day 1 to Day 29

Title

Zilucoplan Sub-protocol: Percentage of Participants Who Achieved Clinical Recovery by Days 8, 15, and 29

Description

Time Frame

Day 8, Day 15, and Day 29

Title

Zilucoplan Sub-protocol: Percentage of Participants Who Achieved Sustained Clinical Recovery

Description

Time Frame

Day 60

Title

Zilucoplan Sub-protocol: Number of Participants With Treatment-emergent Adverse Events

Description

Time Frame

From first dose of study drug to end of study (Day 60)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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).

Facility Information:

Facility Name

Pinnacle Research Group LLC

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Good Samaritan Hospital

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Sharp Chula Vista Medical Center

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

El Centro Regional Medical Center

City

El Centro

State/Province

California

ZIP/Postal Code

92243

Country

United States

Facility Name

University of California Irvine Medical Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Riverside Community Hospital

City

Riverside

State/Province

California

ZIP/Postal Code

92501-4135

Country

United States

Facility Name

National Institute of Clinical Research

City

S. El Monte

State/Province

California

ZIP/Postal Code

91733

Country

United States

Facility Name

University of California Davis Health System

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

UF Health Shands Hospital

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Memorial Hospital Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Grady Health System

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

Great Lakes Clinical Trials

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

The University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Harper University Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201-2018

Country

United States

Facility Name

Sinai Grace Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48235

Country

United States

Facility Name

Detroit Receiving Hospital

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

University of Tennessee Health Sciences Center

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38103

Country

United States

Facility Name

Medical City Ft. Worth

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Texoma Medical Center

City

Sherman

State/Province

Texas

ZIP/Postal Code

75090

Country

United States

Facility Name

MultiCare Health System Institute for Research and Innovation

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Hospital San Juan de Dios

City

Ramos Mejia

State/Province

Buenos Aires

ZIP/Postal Code

1704

Country

Argentina

Facility Name

Hospital General de Agudos Dr. J. M. Ramos Mejia

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1221ADC

Country

Argentina

Facility Name

Hospital General de Agudos Dr. Ignacio Pirovano

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1430BKC

Country

Argentina

Facility Name

Clinica Adventista Belgrano

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1430EGF

Country

Argentina

Facility Name

Hospital Italiano de Rosario

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

Chronos Pesquisa Clinica

City

Brasília

State/Province

Distrito Federal

ZIP/Postal Code

72.145-450

Country

Brazil

Facility Name

HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

City

Goiânia

State/Province

Goiás

ZIP/Postal Code

74605-020

Country

Brazil

Facility Name

Santa Casa de Misericórdia de Belo Horizonte

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30150-221

Country

Brazil

Facility Name

Hospital de Clínicas de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

City

Botucatu

State/Province

Sao Paulo

ZIP/Postal Code

18618-970

Country

Brazil

Facility Name

Praxis Pesquisa Médica

City

Santo André

State/Province

Sao Paulo

ZIP/Postal Code

09090-790

Country

Brazil

Facility Name

Hospital Base Osorno

City

Osorno

ZIP/Postal Code

5290000

Country

Chile

Facility Name

Hospital General de Tijuana

City

Tijuana

State/Province

Baja California Norte

ZIP/Postal Code

22000

Country

Mexico

Facility Name

Hospital Civil de Guadalajara Dr. Juan I. Menchaca

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

Facility Name

Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Hospital Civil de Culiacan

City

Culiacán

State/Province

Sinaloa

ZIP/Postal Code

80030

Country

Mexico

Facility Name

TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich

City

Krasnoyarsk

ZIP/Postal Code

660062

Country

Russian Federation

Facility Name

SBIH of Moscow "Infectious Clinical Hospital # 1 of Department of Healthcare of Moscow"

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

SPb SBIH "Alexandrovskaya City Hospital"

City

Saint Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

St-George Hospital

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

SPb SBIH "Nikolaevskaya Hospital"

City

Saint Petersburg

ZIP/Postal Code

198510

Country

Russian Federation

Facility Name

SPb SBIH "City Pokrovskaya Hospital"

City

Saint Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

SPb SBIH "City Hospital # 40 of Kurortnyi region"

City

Sestroretsk

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

Nelson Mandela Academic Clinical Research Unit (NeMACRU)

City

Mthatha

State/Province

Eastern Cape

ZIP/Postal Code

5100

Country

South Africa

Facility Name

Johese Clinical Research: Unitas

City

Centurion

State/Province

Gauteng

ZIP/Postal Code

0157

Country

South Africa

Facility Name

MERC SiReN

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Drs Sarvan and Moodley

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4320

Country

South Africa

Facility Name

Tread Research

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Tiervlei Trial Centre

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7530

Country

South Africa

Facility Name

2 Military Hospital Internal Medicine

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7800

Country

South Africa

Facility Name

Dr JM Engelbrecht Trial Site

City

Somerset West

State/Province

Western Cape

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Clinical Projects Research SA (PTY) LTD

City

Worcester

State/Province

Western Cape

ZIP/Postal Code

6850

Country

South Africa

Facility Name

Communal Noncommercial Profit "Clinical City Hospital 16 of Dnipro Regional Council"

City

Dnipro

ZIP/Postal Code

49069

Country

Ukraine

Facility Name

CNE of Kharkov RC Reg Cl Infectious Hospital

City

Kharkiv

ZIP/Postal Code

61096

Country

Ukraine

Facility Name

Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1"

City

Kremenchuk

ZIP/Postal Code

39623

Country

Ukraine

Facility Name

City Clinical infectious Hospital

City

Odesa

ZIP/Postal Code

65026

Country

Ukraine

Facility Name

Municipal Non-Profit Enterprise Central City Hospital Of Rivne City Council

City

Rivne

ZIP/Postal Code

33017

Country

Ukraine

Facility Name

CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing URL

http://www.amgen.com/datasharing

Citations:

PubMed Identifier

34473343

Citation

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Results Reference

derived

Learn more about this trial

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

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