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

PHASE3CompletedINTERVENTIONAL
Enrollment

515

Participants

Timeline

Start Date

November 24, 2020

Primary Completion Date

August 3, 2021

Study Completion Date

August 3, 2021

Conditions
COVID-19
Interventions
DRUG

Standard of care

Standard of care (SoC) treatment for COVID-19 infection in line with institutional practice. The SoC may change as new information becomes available about treating COVID-19.

DRUG

Apremilast

Apremilast administered orally as a tablet.

DRUG

Apremilast placebo

Matching apremilast placebo administered orally as a tablet.

DRUG

Lanadelumab

Lanadelumab administered as an intravenous (IV) infusion.

DRUG

Lanadelumab placebo

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

DRUG

Zilucoplan

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

DRUG

Zilucoplan placebo

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

Trial Locations (59)

1704

Hospital San Juan de Dios, Ramos Mejía

2000

Hospital Italiano de Rosario, Rosario

2193

MERC SiReN, Johannesburg

4320

Drs Sarvan and Moodley, Durban

5100

Nelson Mandela Academic Clinical Research Unit (NeMACRU), Mthatha

6850

Clinical Projects Research SA (PTY) LTD, Worcester

7130

Dr JM Engelbrecht Trial Site, Somerset West

7500

Tread Research, Cape Town

7530

Tiervlei Trial Centre, Cape Town

7800

2 Military Hospital Internal Medicine, Cape Town

21029

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

22000

Hospital General de Tijuana, Tijuana

30303

Grady Health System, Atlanta

32216

Memorial Hospital Jacksonville, Jacksonville

32610

UF Health Shands Hospital, Gainesville

33017

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

36207

Pinnacle Research Group LLC, Anniston

38103

University of Tennessee Health Sciences Center, Memphis

39623

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

44340

Hospital Civil de Guadalajara Dr. Juan I. Menchaca, Guadalajara

48073

Detroit Receiving Hospital, Royal Oak

48235

Sinai Grace Hospital, Detroit

49069

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

52242

The University of Iowa, Iowa City

60640

Great Lakes Clinical Trials, Chicago

61096

CNE of Kharkov RC Reg Cl Infectious Hospital, Kharkiv

64460

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

65026

City Clinical infectious Hospital, Odesa

75090

Texoma Medical Center, Sherman

76104

Medical City Ft. Worth, Fort Worth

77030

University of Texas Health Science Center at Houston, Houston

80030

Hospital Civil de Culiacan, Culiacán

91733

National Institute of Clinical Research, South El Monte

91910

Sharp Chula Vista Medical Center, Chula Vista

92243

El Centro Regional Medical Center, El Centro

92868

University of California Irvine Medical Center, Orange

93309

Good Samaritan Hospital, Bakersfield

95817

University of California Davis Health System, Sacramento

98405

MultiCare Health System Institute for Research and Innovation, Tacoma

125367

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

193312

"SPb SBIH Alexandrovskaya City Hospital", Saint Petersburg

194354

St-George Hospital, Saint Petersburg

197706

"SPb SBIH City Hospital # 40 of Kurortnyi region", Sestroretsk

198510

"SPb SBIH Nikolaevskaya Hospital", Saint Petersburg

199106

"SPb SBIH City Pokrovskaya Hospital", Saint Petersburg

660062

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

5290000

Hospital Base Osorno, Osorno

92501-4135

Riverside Community Hospital, Riverside

48201-2018

Harper University Hospital, Detroit

C1221ADC

Hospital General de Agudos Dr. J. M. Ramos Mejia, Ciudad Autonoma Buenos Aires

C1430BKC

Hospital General de Agudos Dr. Ignacio Pirovano, Ciudad Autonoma Buenos Aires

C1430EGF

Clinica Adventista Belgrano, Ciudad Autonoma Buenos Aires

72.145-450

Chronos Pesquisa Clinica, Brasília

74605-020

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

30150-221

Santa Casa de Misericórdia de Belo Horizonte, Belo Horizonte

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

18618-970

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

09090-790

Praxis Pesquisa Médica, Santo André

0157

Johese Clinical Research: Unitas, Centurion

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT04590586 - Study of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalized Patients | Biotech Hunter | Biotech Hunter