VIR-7831 for the Early Treatment of COVID-19 in Outpatients

NCT04545060 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: VIR-7831-5001GSK Study 214367
• Study Type: interventional
• Target: 1,057
• Locations: 7 countries
• Sites: 91

Brief Summary

This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.

Conditions

Covid19

Keywords

SARS-CoV-2; coronavirus; coronavirus disease 2019; COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Progression of COVID-19 Through Day 29

  COVID-19 progression defined as hospitalization \>24 hours or death

  Through Day 29

Secondary Outcomes (28)

• Number of Participants With Adverse Events (AEs)

  Up to 24 weeks

• Number of Participants With Serious Adverse Events (SAEs)

  Up to 24 weeks

• Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions

  Up to 24 weeks

• Number of Participants With Cardiac Events of Special Interest

  Up to 24 weeks

• Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab

  Up to 24 weeks

Study Arms (2)

VIR-7831 (Sotrovimab)

EXPERIMENTAL

Participants received 500 mg sotrovimab administered intravenously (IV)

Biological: VIR-7831 (sotrovimab)

Placebo

PLACEBO COMPARATOR

Participants received placebo administered intravenously (IV)

Drug: Placebo

Interventions

VIR-7831 (sotrovimab) BIOLOGICAL

VIR-7831 (sotrovimab) given by intravenous infusion (single dose)

VIR-7831 (Sotrovimab)

Placebo DRUG

Sterile normal saline (0.9% NaCl) given by intravenous infusion (single dose)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old
• Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms

You may not qualify if:

• Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
• Symptoms consistent with severe COVID-19
• Participants who, in the judgement of the investigator are likely to die in the next 7 days
• Severely immunocompromised participants

Sponsors & Collaborators

• Vir Biotechnology, Inc.: lead
• GlaxoSmithKline: collaborator

Study Sites (91)

Investigative Site

Anniston, Alabama, 36207, United States

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Cullman, Alabama, 35055, United States

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Mesa, Arizona, 85210, United States

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Tucson, Arizona, 85712, United States

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Los Angeles, California, 90017, United States

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Los Angeles, California, 90036, United States

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Northridge, California, 91325, United States

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Oxnard, California, 93030, United States

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Rolling Hills Estates, California, 90274, United States

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Sacramento, California, 95817, United States

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Doral, Florida, 33166, United States

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Gainesville, Florida, 32607, United States

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Hialeah, Florida, 33016, United States

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Miami, Florida, 33122, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33173, United States

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Miami, Florida, 33186, United States

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Miramar, Florida, 33027, United States

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North Miami, Florida, 33169, United States

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Palmetto Bay, Florida, 33157, United States

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Pembroke Pines, Florida, 33024, United States

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Pompano Beach, Florida, 33064, United States

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Tampa, Florida, 33614, United States

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Tampa, Florida, 33615, United States

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Atlanta, Georgia, 30315, United States

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Atlanta, Georgia, 30318, United States

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Decatur, Georgia, 30030, United States

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Stockbridge, Georgia, 30281, United States

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Idaho Falls, Idaho, 83404, United States

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Mishawaka, Indiana, 46544, United States

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Lake Charles, Louisiana, 70601, United States

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Marrero, Louisiana, 70072, United States

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Baltimore, Maryland, 21230, United States

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Caro, Michigan, 48723, United States

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Hazelwood, Missouri, 63042, United States

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Las Vegas, Nevada, 89109, United States

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Las Vegas, Nevada, 89130, United States

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Santa Fe, New Mexico, 87505, United States

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The Bronx, New York, 10456, United States

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Asheboro, North Carolina, 27203, United States

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Charlotte, North Carolina, 28208, United States

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Columbus, Ohio, 43215, United States

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Smithfield, Pennsylvania, 15478, United States

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Chattanooga, Tennessee, 37421, United States

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Austin, Texas, 78705, United States

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Baytown, Texas, 77521, United States

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Beaumont, Texas, 77702, United States

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Dallas, Texas, 75231, United States

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Denton, Texas, 76210, United States

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El Paso, Texas, 79935, United States

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Forney, Texas, 75126, United States

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Houston, Texas, 77017, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77058, United States

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Houston, Texas, 77090, United States

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Humble, Texas, 77338, United States

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Laredo, Texas, 78041, United States

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McAllen, Texas, 78504, United States

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Mesquite, Texas, 75149, United States

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Sugar Land, Texas, 77478, United States

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Kirkland, Washington, 98034, United States

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Seattle, Washington, 98109, United States

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Vienna, 1090, Austria

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Vienna, 1100, Austria

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Belo Horizonte, Minas Gerais, 30110-934, Brazil

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Maringá, Paraná, 87083-240, Brazil

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Natal, Rio Grande do Norte, 590250-50, Brazil

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Passo Fundo, Rio Grande do Sul, 99010-120, Brazil

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Chapecó, Santa Catarina, 89801-355, Brazil

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Campinas, São Paulo, 13060-904, Brazil

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Santo André, São Paulo, 09030-010, Brazil

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Vila Assuncao, São Paulo, 05615-190, Brazil

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M9V 4B4, Canada

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Québec, Quebec, G2J0C4, Canada

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El Agustino, Lima region, 15007, Peru

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Huaral, Lima region, 15131, Peru

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San Isidro, Lima region, 15036, Peru

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Bellavista, Provincia Constitucional del Callao, 7016, Peru

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Bella Vista, 07006, Peru

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Lima, 15082, Peru

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Centelles, Barcelona, 08540, Spain

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Terrassa, Barcelona, 08221, Spain

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Albacete, 02006, Spain

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Girona, 17005, Spain

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Granada, 18014, Spain

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Vigo, 36312, Spain

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Belfast, BT7 2EB, United Kingdom

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Related Publications (8)

• Maher MC, Soriaga LB, Gupta A, Chen YP, di Iulio J, Ledoux S, Smithey MJ, Cathcart AL, McKusick K, Sun D, Aldinger M, Alexander E, Purcell L, Ding X, Peppercorn A, Austin D, Mogalian E, Yeh WW, Shapiro AE, Corti D, Virgin HW, Pang PS, Telenti A. Antibody therapy reverses biological signatures of COVID-19 progression. Cell Rep Med. 2022 Aug 16;3(8):100721. doi: 10.1016/j.xcrm.2022.100721.

  PMID: 35977462 RESULT

• Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Rodrigues Falci D, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Parra S, Sager JE, Austin D, Peppercorn A, Alexander E, Yeh WW, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Apr 5;327(13):1236-1246. doi: 10.1001/jama.2022.2832.

  PMID: 35285853 RESULT

• Gupta A, Gonzalez-Rojas Y, Juarez E, Crespo Casal M, Moya J, Falci DR, Sarkis E, Solis J, Zheng H, Scott N, Cathcart AL, Hebner CM, Sager J, Mogalian E, Tipple C, Peppercorn A, Alexander E, Pang PS, Free A, Brinson C, Aldinger M, Shapiro AE; COMET-ICE Investigators. Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. N Engl J Med. 2021 Nov 18;385(21):1941-1950. doi: 10.1056/NEJMoa2107934. Epub 2021 Oct 27.

  PMID: 34706189 RESULT

• Subramanian S, Schnell G, Iulio JD, Gupta AK, Shapiro AE, Sarkis EH, Lopuski A, Peppercorn A, Aldinger M, Hebner CM, Cathcart AL. Resistance analysis following sotrovimab treatment in participants with COVID-19 during the phase III COMET-ICE study. Future Virol. 2023 Nov:10.2217/fvl-2023-0146. doi: 10.2217/fvl-2023-0146. Epub 2023 Dec 7.

  PMID: 38074312 DERIVED

• Satram S, Ghafoori P, Reyes CM, Keeley TJH, Birch HJ, Brintziki D, Aldinger M, Alexander E, Lopuski A, Sarkis EH, Gupta A, Shapiro AE, Powers JH 3rd. Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19. J Patient Rep Outcomes. 2023 Sep 13;7(1):92. doi: 10.1186/s41687-023-00621-8.

  PMID: 37702920 DERIVED

• Keeley TJH, Satram S, Ghafoori P, Reyes C, Birch HJ, Raymond K, Gelhorn HL, Kosinski M, Saucier CD, Mitchell Foster A, Lopuski A, Powers JH 3rd. Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus(c)) instrument in patients with COVID-19. Qual Life Res. 2023 Jun;32(6):1645-1657. doi: 10.1007/s11136-022-03336-3. Epub 2023 Jan 27.

  PMID: 36703019 DERIVED

• Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

  PMID: 35713300 DERIVED

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

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

sotrovimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Inquiry
• Organization: Vir Biotechnology, Inc.

clinicaltrials@vir.bio

415-654-5281

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 10, 2020
• Study Start: August 27, 2020
• Primary Completion: April 8, 2021
• Study Completion: September 2, 2021
• Last Updated: November 7, 2022
• Results First Posted: November 7, 2022

Record last verified: 2022-10

Locations

US (63); PE (6); BR (10); ES (6); CA (3); GB (1); AU (2)