Trial Outcomes & Findings for Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients (NCT NCT04590586)

Last Updated: 2022-06-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

515 participants

Primary outcome timeframe

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

Results posted on

2022-06-29

Participant Flow

This adaptive platform study consisted of 3 sub-protocols, each designed to assess a candidate agent as treatment for coronavirus disease 2019 (COVID-19) in hospitalized adult patients who had severe infection with acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The control group for a candidate agent includes participants randomized to any matching placebo for a candidate agent if certain criteria were met (shared placebo).

Participants were initially randomized to an active candidate agent or generically to placebo plus standard of care (SoC) for sub-protocols for which they met eligibility. Participants randomized to placebo plus SoC were subsequently randomized equally to a matching placebo for an available candidate agent whose sub-protocol the participant qualified for. Randomization was stratified by baseline clinical severity of 2 on the 8-point ordinal scale (yes/no) and remdesivir use at baseline (yes/no).

Participant milestones

Participant milestones
Measure	Lanadelumab + Standard of Care Participants 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.	Lanadelumab Placebo + Standard of Care Participants 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.	Apremilast + Standard of Care Participants randomized to received 30 mg apremilast orally twice a day (BID) in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.	Apremilast Placebo + Standard of Care Participants 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, whichever occurred first.	Zilucoplan + Standard of Care Participants 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.	Zilucoplan Placebo + Standard of Care Participants 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.
Overall Study STARTED	28	1	194	184	100	8
Overall Study Received Study Drug	27	1	189	182	95	7
Overall Study Full Analysis Set	28	34	194	190	100	75
Overall Study COMPLETED	15	0	139	138	70	4
Overall Study NOT COMPLETED	13	1	55	46	30	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Lanadelumab + Standard of Care Participants 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.	Lanadelumab Placebo + Standard of Care Participants 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.	Apremilast + Standard of Care Participants randomized to received 30 mg apremilast orally twice a day (BID) in addition to standard of care treatment for 14 days or until hospital discharge, whichever occurred first.	Apremilast Placebo + Standard of Care Participants 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, whichever occurred first.	Zilucoplan + Standard of Care Participants 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.	Zilucoplan Placebo + Standard of Care Participants 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.
Overall Study Death	7	1	37	34	19	3
Overall Study Lost to Follow-up	3	0	11	11	6	0
Overall Study Withdrawal by Subject	0	0	6	0	3	0
Overall Study Other	3	0	1	1	2	1

Baseline Characteristics

Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lanadelumab + Standard of Care n=28 Participants Participants 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.	Lanadelumab Placebo Control n=34 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Apremilast + Standard of Care n=194 Participants Participants 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, whichever occurred first.	Apremilast Placebo Control n=190 Participants Includes participants randomized to receive matching placebo to apremilast plus standard of care treatment as well as participants who were randomized to receive placebo to lanadelumab or placebo to zilucoplan plus standard of care treatment at a site concurrently enrolling apremilast sub-protocol participants and who would have been eligible for the apremilast sub-protocol.	Zilucoplan + Standard of Care n=100 Participants Participants 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.	Zilucoplan Placebo +Control n=75 Participants Includes participants randomized to receive matching placebo to zilucoplan plus standard of care treatment as well as participants who were randomized to receive placebo to lanadelumab or placebo to apremilast plus standard of care treatment at a site that enrolled at least one participant in the zilucoplan sub-protocol.	Total n=621 Participants Total of all reporting groups
Age, Continuous Lanadelumab Sub-protocol	53.4 years STANDARD_DEVIATION 15.34 • n=28 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	59.6 years STANDARD_DEVIATION 13.50 • n=34 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	56.8 years STANDARD_DEVIATION 14.57 • n=62 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Continuous Apremilast Sub-protocol	—	—	57.2 years STANDARD_DEVIATION 13.84 • n=194 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	55.7 years STANDARD_DEVIATION 13.37 • n=190 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	56.5 years STANDARD_DEVIATION 13.61 • n=384 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Continuous Zilucoplan Sub-protocol	—	—	—	—	53.2 years STANDARD_DEVIATION 14.13 • n=100 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	58.4 years STANDARD_DEVIATION 13.62 • n=75 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	55.4 years STANDARD_DEVIATION 14.11 • n=175 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Lanadelumab Sub-protocol · ≥ 18 to ≤ 49 years	13 Participants n=28 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	8 Participants n=34 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	21 Participants n=62 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Lanadelumab Sub-protocol · ≥ 50 to ≤ 64 years	7 Participants n=28 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	15 Participants n=34 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	22 Participants n=62 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Lanadelumab Sub-protocol · ≥ 65 to ≤ 84 years	8 Participants n=28 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	10 Participants n=34 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	18 Participants n=62 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Lanadelumab Sub-protocol · ≥ 85 years	0 Participants n=28 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	1 Participants n=34 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	1 Participants n=62 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Apremilast Sub-protocol · ≥ 18 to ≤ 49 years	—	—	51 Participants n=194 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	56 Participants n=190 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	107 Participants n=384 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Apremilast Sub-protocol · ≥ 50 to ≤ 64 years	—	—	76 Participants n=194 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	81 Participants n=190 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	157 Participants n=384 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Apremilast Sub-protocol · ≥ 65 to ≤ 84 years	—	—	64 Participants n=194 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	52 Participants n=190 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	116 Participants n=384 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Apremilast Sub-protocol · ≥ 85 years	—	—	3 Participants n=194 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	1 Participants n=190 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	4 Participants n=384 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Zilucoplan Sub-protocol · ≥ 18 to ≤ 49 years	—	—	—	—	45 Participants n=100 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	19 Participants n=75 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	64 Participants n=175 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Zilucoplan Sub-protocol · ≥ 50 to ≤ 64 years	—	—	—	—	36 Participants n=100 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	29 Participants n=75 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	65 Participants n=175 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Zilucoplan Sub-protocol · ≥ 65 to ≤ 84 years	—	—	—	—	16 Participants n=100 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	26 Participants n=75 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	42 Participants n=175 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Age, Customized Zilucoplan Sub-protocol · ≥ 85 years	—	—	—	—	3 Participants n=100 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	1 Participants n=75 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	4 Participants n=175 Participants • Age data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Sex: Female, Male Lanadelumab Sub-protocol · Female	11 Participants n=28 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	9 Participants n=34 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	20 Participants n=62 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Sex: Female, Male Lanadelumab Sub-protocol · Male	17 Participants n=28 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	25 Participants n=34 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	42 Participants n=62 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Sex: Female, Male Apremilast Sub-protocol · Female	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	84 Participants n=194 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	72 Participants n=190 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	156 Participants n=384 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Sex: Female, Male Apremilast Sub-protocol · Male	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	110 Participants n=194 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	118 Participants n=190 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	228 Participants n=384 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Sex: Female, Male Zilucoplan Sub-protocol · Female	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	34 Participants n=100 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	28 Participants n=75 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	62 Participants n=175 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Sex: Female, Male Zilucoplan Sub-protocol · Male	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	66 Participants n=100 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	47 Participants n=75 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	113 Participants n=175 Participants • Sex data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Ethnicity (NIH/OMB) Lanadelumab Sub-protocol · Hispanic or Latino	18 Participants n=28 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	19 Participants n=34 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	37 Participants n=62 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Ethnicity (NIH/OMB) Lanadelumab Sub-protocol · Not Hispanic or Latino	10 Participants n=28 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	15 Participants n=34 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	25 Participants n=62 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Ethnicity (NIH/OMB) Lanadelumab Sub-protocol · Unknown or Not Reported	0 Participants n=28 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=34 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	0 Participants n=62 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Ethnicity (NIH/OMB) Apremilast Sub-protocol · Hispanic or Latino	—	—	75 Participants n=194 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	72 Participants n=190 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	147 Participants n=384 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Ethnicity (NIH/OMB) Apremilast Sub-protocol · Not Hispanic or Latino	—	—	108 Participants n=194 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	112 Participants n=190 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	220 Participants n=384 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Ethnicity (NIH/OMB) Apremilast Sub-protocol · Unknown or Not Reported	—	—	11 Participants n=194 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	6 Participants n=190 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	17 Participants n=384 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Ethnicity (NIH/OMB) Zilucoplan Sub-protocol · Hispanic or Latino	—	—	—	—	65 Participants n=100 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	32 Participants n=75 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	97 Participants n=175 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Ethnicity (NIH/OMB) Zilucoplan Sub-protocol · Not Hispanic or Latino	—	—	—	—	35 Participants n=100 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	43 Participants n=75 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	78 Participants n=175 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Ethnicity (NIH/OMB) Zilucoplan Sub-protocol · Unknown or Not Reported	—	—	—	—	0 Participants n=100 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=75 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=175 Participants • Ethnicity data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Lanadelumab Sub-protocol · American Indian or Alaska Native	1 Participants n=28 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=34 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	3 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	1 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	5 Participants n=237 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Lanadelumab Sub-protocol · Asian	0 Participants n=28 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=34 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	3 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	5 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	8 Participants n=237 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Lanadelumab Sub-protocol · Native Hawaiian or Other Pacific Islander	0 Participants n=28 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=34 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	0 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=237 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Lanadelumab Sub-protocol · Black or African American	3 Participants n=28 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	2 Participants n=34 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	5 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	5 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	15 Participants n=237 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Lanadelumab Sub-protocol · White	20 Participants n=28 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	28 Participants n=34 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	75 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	58 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	181 Participants n=237 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Lanadelumab Sub-protocol · More than one race	2 Participants n=28 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	1 Participants n=34 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	8 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	2 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	13 Participants n=237 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Lanadelumab Sub-protocol · Unknown or Not Reported	2 Participants n=28 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	3 Participants n=34 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	6 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	4 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	15 Participants n=237 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Apremilast Sub-protocol · American Indian or Alaska Native	—	—	0 Participants n=194 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	1 Participants n=190 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	1 Participants n=384 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Apremilast Sub-protocol · Asian	—	—	11 Participants n=194 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	7 Participants n=190 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	18 Participants n=384 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Apremilast Sub-protocol · Native Hawaiian or Other Pacific Islander	—	—	0 Participants n=194 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	1 Participants n=190 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	1 Participants n=384 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Apremilast Sub-protocol · Black or African American	—	—	9 Participants n=194 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	9 Participants n=190 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	18 Participants n=384 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Apremilast Sub-protocol · White	—	—	151 Participants n=194 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	151 Participants n=190 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	302 Participants n=384 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Apremilast Sub-protocol · More than one race	—	—	4 Participants n=194 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	7 Participants n=190 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	11 Participants n=384 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Apremilast Sub-protocol · Unknown or Not Reported	—	—	19 Participants n=194 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	14 Participants n=190 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	33 Participants n=384 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Zilucoplan Sub-protocol · American Indian or Alaska Native	—	—	—	—	3 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	1 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	4 Participants n=175 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Zilucoplan Sub-protocol · Asian	—	—	—	—	3 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	5 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	8 Participants n=175 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Zilucoplan Sub-protocol · Native Hawaiian or Other Pacific Islander	—	—	—	—	0 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=175 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Zilucoplan Sub-protocol · Black or African American	—	—	—	—	5 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	5 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	10 Participants n=175 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Zilucoplan Sub-protocol · White	—	—	—	—	75 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	58 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	133 Participants n=175 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Zilucoplan Sub-protocol · More than one race	—	—	—	—	8 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	2 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	10 Participants n=175 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Race (NIH/OMB) Zilucoplan Sub-protocol · Unknown or Not Reported	—	—	—	—	6 Participants n=100 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	4 Participants n=75 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	10 Participants n=175 Participants • Race data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Lanadelumab Sub-protocol · North America	9 Participants n=28 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	9 Participants n=34 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	18 Participants n=62 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Lanadelumab Sub-protocol · Latin America	18 Participants n=28 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	20 Participants n=34 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	38 Participants n=62 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Lanadelumab Sub-protocol · Eastern Europe	0 Participants n=28 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	0 Participants n=34 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	0 Participants n=62 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Lanadelumab Sub-protocol · Rest of the World	1 Participants n=28 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	5 Participants n=34 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	6 Participants n=62 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Apremilast Sub-protocol · North America	—	—	53 Participants n=194 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	60 Participants n=190 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	113 Participants n=384 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Apremilast Sub-protocol · Latin America	—	—	60 Participants n=194 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	50 Participants n=190 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	110 Participants n=384 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Apremilast Sub-protocol · Eastern Europe	—	—	51 Participants n=194 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	53 Participants n=190 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	104 Participants n=384 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Apremilast Sub-protocol · Rest of the World	—	—	30 Participants n=194 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	27 Participants n=190 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	57 Participants n=384 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Zilucoplan Sub-protocol · North America	—	—	—	—	26 Participants n=100 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	10 Participants n=75 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	36 Participants n=175 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Zilucoplan Sub-protocol · Latin America	—	—	—	—	65 Participants n=100 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	33 Participants n=75 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	98 Participants n=175 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Zilucoplan Sub-protocol · Eastern Europe	—	—	—	—	6 Participants n=100 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	14 Participants n=75 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	20 Participants n=175 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Region Zilucoplan Sub-protocol · Rest of the World	—	—	—	—	3 Participants n=100 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	18 Participants n=75 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	21 Participants n=175 Participants • Region data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Remdesivir Use at Baseline Lanadelumab Sub-protocol · Yes	7 Participants n=28 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	5 Participants n=34 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	12 Participants n=62 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Remdesivir Use at Baseline Lanadelumab Sub-protocol · No	21 Participants n=28 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	29 Participants n=34 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	50 Participants n=62 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Remdesivir Use at Baseline Apremilast Sub-protocol · Yes	—	—	45 Participants n=194 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	44 Participants n=190 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	89 Participants n=384 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Remdesivir Use at Baseline Apremilast Sub-protocol · No	—	—	149 Participants n=194 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	146 Participants n=190 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	295 Participants n=384 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Remdesivir Use at Baseline Zilucoplan Sub-protocol · Yes	—	—	—	—	22 Participants n=100 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	9 Participants n=75 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	31 Participants n=175 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Remdesivir Use at Baseline Zilucoplan Sub-protocol · No	—	—	—	—	78 Participants n=100 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	66 Participants n=75 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	144 Participants n=175 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Clinical Severity Score of 2 Lanadelumab Sub-protocol · Yes (Grade 2)	3 Participants n=28 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	4 Participants n=34 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	7 Participants n=62 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Clinical Severity Score of 2 Lanadelumab Sub-protocol · No (Grade 3-5)	25 Participants n=28 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	30 Participants n=34 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	—	—	55 Participants n=62 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Clinical Severity Score of 2 Apremilast Sub-protocol · Yes (Grade 2)	—	—	11 Participants n=194 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	9 Participants n=190 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	20 Participants n=384 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Clinical Severity Score of 2 Apremilast Sub-protocol · No (Grade 3-5)	—	—	183 Participants n=194 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	181 Participants n=190 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	—	—	364 Participants n=384 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Clinical Severity Score of 2 Zilucoplan Sub-protocol · Yes (Grade 2)	—	—	—	—	8 Participants n=100 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	6 Participants n=75 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	14 Participants n=175 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.
Clinical Severity Score of 2 Zilucoplan Sub-protocol · No (Grade 3-5)	—	—	—	—	92 Participants n=100 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	69 Participants n=75 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.	161 Participants n=175 Participants • Data are reported separately for each subprotocol so as not to double-count participants in the shared placebo control groups.

PRIMARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=25 Participants Participants 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.	Lanadelumab Placebo Control n=30 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Lanadelumab Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	10.0 days Interval 5.0 to Not estimable due to the low number of events	15.5 days Interval 8.0 to Not estimable due to the low number of events	—

PRIMARY outcome

Population: 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.

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=194 Participants Participants 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.	Lanadelumab Placebo Control n=190 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Apremilast Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	14.0 days Interval 11.0 to 15.0	14.0 days Interval 11.0 to 15.0	—

PRIMARY outcome

Population: 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.

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=100 Participants Participants 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.	Lanadelumab Placebo Control n=75 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Zilucoplan Sub-protocol: Time to Confirmed Clinical Recovery Without Rehospitalization Through Day 29	14.0 days Interval 11.0 to 22.0	15.0 days Interval 11.0 to 22.0	—

SECONDARY outcome

Timeframe: Day 29

Population: Lanadelumab sub-protocol primary analysis set

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.

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=25 Participants Participants 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.	Lanadelumab Placebo Control n=30 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Oxygen-Free Recovery at Day 29	52.0 percentage of participants Interval 31.31 to 72.2	56.7 percentage of participants Interval 37.43 to 74.54	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 29

Population: Lanadelumab sub-protocol primary analysis set

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

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=25 Participants Participants 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.	Lanadelumab Placebo Control n=30 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
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	72.0 percentage of participants Interval 50.61 to 87.93	63.3 percentage of participants Interval 43.86 to 80.07	—

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: Lanadelumab sub-protocol primary analysis set

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.

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=25 Participants Participants 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.	Lanadelumab Placebo Control n=30 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Lanadelumab Sub-protocol: Percentage of Participants Who Died Before or on Day 29	32.0 percentage of participants Interval 14.95 to 53.5	30.0 percentage of participants Interval 14.73 to 49.4	—

SECONDARY outcome

Timeframe: Day 8, Day 15, and Day 29

Population: Lanadelumab sub-protocol primary analysis set

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.

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=25 Participants Participants 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.	Lanadelumab Placebo Control n=30 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 15 · 4 (Hospitalized, requiring supplemental oxygen)	0 Participants	2 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 8 · 6 (Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care)	1 Participants	1 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 8 · 7 (Not hospitalized, limitation on activities and/or requiring home oxygen)	2 Participants	3 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 29 · 7 (Not hospitalized, limitation on activities and/or requiring home oxygen)	5 Participants	6 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 8 · 1 (Death or discharged to hospice care)	3 Participants	3 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 8 · 2 (Hospitalized on invasive mechanical ventilation or ECMO)	4 Participants	6 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 8 · 3 (Hospitalized on noninvasive ventilation or high-flow oxygen devices)	3 Participants	4 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 8 · 4 (Hospitalized, requiring supplemental oxygen)	2 Participants	6 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 15 · Missing	1 Participants	0 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 8 · 5 (Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care)	1 Participants	0 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 8 · 8 (Not hospitalized, no limitations on activities)	8 Participants	7 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 8 · Missing	1 Participants	0 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 15 · 1 (Death or discharged to hospice care)	3 Participants	7 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 15 · 2 (Hospitalized on invasive mechanical ventilation or ECMO)	3 Participants	4 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 15 · 3 (Hospitalized on noninvasive ventilation or high-flow oxygen devices)	1 Participants	0 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 15 · 5 (Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care)	0 Participants	0 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 15 · 6 (Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care)	0 Participants	1 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 15 · 7 (Not hospitalized, limitation on activities and/or requiring home oxygen)	5 Participants	3 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 15 · 8 (Not hospitalized, no limitations on activities)	12 Participants	13 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 29 · 1 (Death or discharged to hospice care)	7 Participants	9 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 29 · 2 (Hospitalized on invasive mechanical ventilation or ECMO)	0 Participants	2 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 29 · 3 (Hospitalized on noninvasive ventilation or high-flow oxygen devices)	0 Participants	0 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 29 · 4 (Hospitalized, requiring supplemental oxygen)	0 Participants	0 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 29 · 5 (Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care)	0 Participants	0 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 29 · 6 (Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care)	0 Participants	0 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 29 · 8 (Not hospitalized, no limitations on activities)	12 Participants	13 Participants	—
Lanadelumab Sub-protocol: Clinical Severity Status 8-Point Ordinal Scale Score at Days 8, 15, and 29 Day 29 · Missing	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Day 2 to Day 29

Population: Lanadelumab sub-protocol primary analysis set

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

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=25 Participants Participants 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.	Lanadelumab Placebo Control n=30 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29 3 (Hospitalized on noninvasive ventilation or high-flow oxygen devices)	6 Participants	5 Participants	—
Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29 1 (Death or discharged to hospice care)	8 Participants	9 Participants	—
Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29 2 (Hospitalized on invasive mechanical ventilation or ECMO)	0 Participants	4 Participants	—
Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29 4 (Hospitalized, requiring supplemental oxygen)	8 Participants	11 Participants	—
Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29 5 (Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care)	1 Participants	0 Participants	—
Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29 6 (Hospitalized, not requiring supplemental oxygen, no longer requires ongoing medical care)	0 Participants	0 Participants	—
Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29 7 (Not hospitalized, limitation on activities and/or requiring home oxygen)	0 Participants	0 Participants	—
Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29 8 (Not hospitalized, no limitations on activities)	1 Participants	1 Participants	—
Lanadelumab Sub-protocol: Worst Post-Baseline Score on Clinical Severity Status 8-point Ordinal Scale From Baseline to Day 29 Missing	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: Lanadelumab sub-protocol primary analysis set

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).

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=25 Participants Participants 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.	Lanadelumab Placebo Control n=30 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 0 days	13 Participants	10 Participants	—
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 1 day	1 Participants	1 Participants	—
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 30 days (death or discharged to hospice care)	7 Participants	9 Participants	—
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 3 days	0 Participants	1 Participants	—
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 5 days	0 Participants	1 Participants	—
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 6 days	0 Participants	2 Participants	—
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 8 days	1 Participants	3 Participants	—
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 11 days	2 Participants	0 Participants	—
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 13 days	1 Participants	1 Participants	—
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 15 days	0 Participants	1 Participants	—
Lanadelumab Sub-protocol: Number of Intensive Care Unit (ICU) Days From Day 1 Through Day 29 21 days	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: Lanadelumab sub-protocol primary analysis set

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.

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=25 Participants Participants 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.	Lanadelumab Placebo Control n=30 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Lanadelumab Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29 24 days	0 Participants	1 Participants	—
Lanadelumab Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29 0 days	17 Participants	18 Participants	—
Lanadelumab Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29 6 days	0 Participants	1 Participants	—
Lanadelumab Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29 16 days	0 Participants	1 Participants	—
Lanadelumab Sub-protocol: Number of Invasive Mechanical Ventilator Days From Day 1 Through Day 29 30 days (death or discharged to hospice care)	8 Participants	9 Participants	—

SECONDARY outcome

Timeframe: Day 8, Day 15, and Day 29

Population: Lanadelumab sub-protocol primary analysis set

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: 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 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

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=25 Participants Participants 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.	Lanadelumab Placebo Control n=30 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Clinical Recovery by Days 8, 15, and 29 Day 8	44.0 percentage of participants Interval 24.4 to 65.07	36.7 percentage of participants Interval 19.93 to 56.14	—
Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Clinical Recovery by Days 8, 15, and 29 Day 15	56.0 percentage of participants Interval 34.93 to 75.6	56.7 percentage of participants Interval 37.43 to 75.54	—
Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Clinical Recovery by Days 8, 15, and 29 Day 29	60.0 percentage of participants Interval 38.67 to 78.87	63.3 percentage of participants Interval 43.86 to 80.07	—

SECONDARY outcome

Timeframe: Day 60

Population: Lanadelumab sub-protocol primary analysis set

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: 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 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

Outcome measures

Outcome measures
Measure	Lanadelumab + Standard of Care n=25 Participants Participants 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.	Lanadelumab Placebo Control n=30 Participants Includes participants randomized to receive matching placebo to lanadelumab plus standard of care treatment as well as participants who were randomized to receive placebo to apremilast or placebo to zilucoplan plus standard of care treatment at a site that enrolled at least one participant in the lanadelumab sub-protocol.	Lanadelumab Placebo + Standard of Care Participants received placebo to lanadelumab by intravenous infusion on Day 1, and a second dose administered on Day 4 in, addition to standard of care.
Lanadelumab Sub-protocol: Percentage of Participants Who Achieved Sustained Clinical Recovery	40.0 percentage of participants Interval 21.13 to 61.33	56.7 percentage of participants Interval 37.43 to 74.54	—

SECONDARY outcome

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

Population: Lanadelumab safety analysis set included all participants in the lanadelumab FAS who received at least one dose of study drug.

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.