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A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04770467
Recruitment Status : Withdrawn (The study will no longer move forward due to recent changes in COVID-19 cases in Hong Kong.)
First Posted : February 25, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Brii Biosciences Limited ( Brii Biosciences, Inc. )

Study Description
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Brief Summary:
This study is to evaluate the safety, efficacy and pharmacokinetics profile of human monoclonal antibodies, BRII-196 and BRII-198 compared with placebo in patients with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: BRII-196 and BRII-198 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BRII-196 and BRII-198 in adult subjects with severe COVID-19 Drug: BRII-196 and BRII-198
BRII-196 and BRII-198 given by intravenous administration
Placebo Comparator: Placebo in adult subjects with severe COVID-19 Drug: Placebo
Placebo given by intravenous administration
Experimental: BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19 Drug: BRII-196 and BRII-198
BRII-196 and BRII-198 given by intravenous administration
Experimental: Placebo in adult subjects with mild-moderate COVID-19 Drug: Placebo
Placebo given by intravenous administration


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Day 29 ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: up to Day 29 ]
  3. Change from pre-dose baseline in RBC count [ Time Frame: Day 29 ]
  4. Change from pre-dose baseline in WBC count [ Time Frame: Day 29 ]
  5. Change from pre-dose baseline in Platelets count [ Time Frame: Day 29 ]
  6. Change from pre-dose baseline in Hemoglobin result [ Time Frame: Day 29 ]
  7. Change from pre-dose baseline in Creatine kinase result [ Time Frame: Day 29 ]
  8. Change from pre-dose baseline in Alanine aminotransferase (ALT) result [ Time Frame: Day 29 ]
  9. Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8 [ Time Frame: Day 8 ]

Secondary Outcome Measures :
  1. Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19 [ Time Frame: up to Day 29 ]
  2. Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization [ Time Frame: up to 72 weeks ]
  3. Assessment of PK parameters: maximum serum concentration observed (Cmax) [ Time Frame: up to Day 85 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject ≥ 18 years, signing the informed consent.
  • SARS-CoV-2 infection by PCR ≤ 7 days
  • One or more of COVID-19 related symptoms or measured fever present within 48 hours prior to study entry (subjects with mild-moderate COVID-19)

Exclusion Criteria:

  • Recurring COVID-19 patients.
  • Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent
  • Receipt of convalescent COVID-19 plasma, SARS-CoV-2 mAb treatment, SARS-CoV-2 vaccine, or other investigational treatments prior to study entry.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770467


Locations
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China
Investigative Site 1
Hong Kong, China
Sponsors and Collaborators
Brii Biosciences, Inc.
Investigators
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Study Director: Yao Zhang, MD Brii Biosciences, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Brii Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04770467    
Other Study ID Numbers: BRII-196-198-002
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brii Biosciences Limited ( Brii Biosciences, Inc. ):
COVID-19 phase 2
monoclonal antibody
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases