Trial · NCT04590586

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

NCT04590586, Phase 3, Completed, Amgen; results first posted 2022-06-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients. Trials, record NCT04590586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04590586

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients
NCT number: NCT04590586
Status: Completed
Phases: Phase 3
Enrollment: 515 participants, actual
Lead sponsor: Amgen
Conditions: COVID-19
Interventions: Standard of care, Apremilast, Apremilast placebo, Lanadelumab, Lanadelumab placebo, Zilucoplan, Zilucoplan placebo
First posted: 2020-10-19
Last updated: 2022-06-29
Results first posted: 2022-06-29

Source ClinicalTrials.gov

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Lanadelumab Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	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	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.
Primary	Apremilast Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	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	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.
Primary	Zilucoplan Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	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	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.
Secondary	Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29	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.
Secondary	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	Baseline (Day 1) and 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: 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
Secondary	Lanadelumab Sub-protocol: Percentage of Participants Who Died Before or on Day 29	Day 1 to 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.
Secondary	Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29	Day 8, Day 15, and Day 29	The clinical severity status 8-point ordinal scale scores are: 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 with a score of 7 who were discharged to hospice care are counted with participants with a score of 1 (death) for this endpoint.
Secondary	Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29	Day 2 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: 1. Death 2. Hospitalized, on invasive mechanical ventilation or 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
Secondary	Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29	Day 1 to 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).
Secondary	Lanadelumab Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29	Day 1 to 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.

1 to 10 of 33Source ClinicalTrials.gov

See all 33 registered outcomes

Outcomes33

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Lanadelumab Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	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	The lanadelumab sub-protocol primary analysis set includes all participants who were randomized to lanadelumab as well as all participants who were randomized to any placebo arm included in the control arm for lanadelumab with a baseline clinical severity status of Grade 3 to Grade 5 on the clinical severity status 8-point ordinal scale.	days	MEDIAN
PRIMARY	Apremilast Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	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	The apremilast full analysis set (FAS) includes all participants who were randomized to the apremilast arm as well as all participants who were randomized to any placebo arm included in the control arm for apremilast.	days	MEDIAN
PRIMARY	Zilucoplan Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	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	The zilucoplan full analysis set includes all participants who were randomized to the zilucoplan arm as well as all participants who were randomized to any placebo arm included in the control arm for zilucoplan.	days	MEDIAN
SECONDARY	Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29	Day 29	Lanadelumab sub-protocol primary analysis set	percentage of participants	NUMBER
SECONDARY	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	Baseline (Day 1) and Day 29	Lanadelumab sub-protocol primary analysis set	percentage of participants	NUMBER
SECONDARY	Lanadelumab Sub-protocol: Percentage of Participants Who Died Before or on Day 29	Day 1 to Day 29	Lanadelumab sub-protocol primary analysis set	percentage of participants	NUMBER
SECONDARY	Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29	Day 8, Day 15, and Day 29	Lanadelumab sub-protocol primary analysis set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29	Day 2 to Day 29	Lanadelumab sub-protocol primary analysis set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29	Day 1 to Day 29	Lanadelumab sub-protocol primary analysis set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Lanadelumab Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29	Day 1 to Day 29	Lanadelumab sub-protocol primary analysis set	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 33Source ClinicalTrials.gov

See all 33 outcomes

Results by group505

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Lanadelumab Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	Lanadelumab + Standard of Care	10.0	95% Confidence Interval 5.00 to NA	days
Lanadelumab Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	Lanadelumab Placebo Control	15.5	95% Confidence Interval 8.00 to NA	days
Apremilast Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	Apremilast + Standard of Care	14.0	95% Confidence Interval 11.00 to 15.00	days
Apremilast Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	Apremilast Placebo Control	14.0	95% Confidence Interval 11.00 to 15.00	days
Zilucoplan Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	Zilucoplan + Standard of Care	14.0	95% Confidence Interval 11.00 to 22.0	days
Zilucoplan Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	Zilucoplan Placebo Control	15.0	95% Confidence Interval 11.00 to 22.00	days
Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29	Lanadelumab + Standard of Care	52.0	95% Confidence Interval 31.31 to 72.20	percentage of participants
Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29	Lanadelumab Placebo Control	56.7	95% Confidence Interval 37.43 to 74.54	percentage of participants
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	Lanadelumab + Standard of Care	72.0	95% Confidence Interval 50.61 to 87.93	percentage of participants
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	Lanadelumab Placebo Control	63.3	95% Confidence Interval 43.86 to 80.07	percentage of participants

1 to 10 of 505Source ClinicalTrials.gov

See all 505 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lanadelumab + Standard of Care	28
Overall Study	STARTED	Lanadelumab Placebo + Standard of Care	1
Overall Study	STARTED	Apremilast + Standard of Care	194
Overall Study	STARTED	Apremilast Placebo + Standard of Care	184
Overall Study	STARTED	Zilucoplan + Standard of Care	100
Overall Study	STARTED	Zilucoplan Placebo + Standard of Care	8
Overall Study	Received Study Drug	Lanadelumab + Standard of Care	27
Overall Study	Received Study Drug	Lanadelumab Placebo + Standard of Care	1
Overall Study	Received Study Drug	Apremilast + Standard of Care	189
Overall Study	Received Study Drug	Apremilast Placebo + Standard of Care	182

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events654

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Lanadelumab + SoC	2	27
other	Anaemia	Blood and lymphatic system disorders	Lanadelumab Placebo + SoC	1	1
other	Anaemia	Blood and lymphatic system disorders	Apremilast + SoC	9	189
other	Anaemia	Blood and lymphatic system disorders	Apremilast Placebo + SoC	4	182
other	Anaemia	Blood and lymphatic system disorders	Zilucoplan + SoC	9	95
other	Anaemia	Blood and lymphatic system disorders	Zilucoplan Placebo + SoC	0	7
other	Leukopenia	Blood and lymphatic system disorders	Lanadelumab + SoC	0	27
other	Leukopenia	Blood and lymphatic system disorders	Lanadelumab Placebo + SoC	1	1
other	Leukopenia	Blood and lymphatic system disorders	Apremilast + SoC	0	189
other	Leukopenia	Blood and lymphatic system disorders	Apremilast Placebo + SoC	0	182

1 to 10 of 654Source ClinicalTrials.gov

See all 654 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lanadelumab + SoC	8	28
Total, all-cause mortality	Lanadelumab Placebo + SoC	1	1
Total, all-cause mortality	Apremilast + SoC	37	194
Total, all-cause mortality	Apremilast Placebo + SoC	35	184
Total, all-cause mortality	Zilucoplan + SoC	20	100
Total, all-cause mortality	Zilucoplan Placebo + SoC	3	8
Total, other adverse events	Lanadelumab + SoC	12	27
Total, other adverse events	Lanadelumab Placebo + SoC	1	1
Total, other adverse events	Apremilast + SoC	63	189
Total, other adverse events	Apremilast Placebo + SoC	50	182

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34473343	DERIVED	PubMed
42928084	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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