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COVID-19Phase 2NCT04787211

A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

A Phase 2 study testing BRII-196 and BRII-198 in people with COVID-19, run by Brii Biosciences Limited at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this phase 2 study is to evaluate the safety and efficacy of single dose IV infusion of BRII-196 and BRII-198 given as combination therapy in patients with severe COVID-19, and mild to moderate COVID-19 and asymptomatic carrier. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
BRII-196 and BRII-198
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
6 sitesChina
Study dates
20 Jun 2021to 2 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Beijing Ditan Hospital Capital Medical University

    Beijing, Beijing Municipality, 100015

  • Guangzhou Eighth Hospital, Guangzhou Medical University

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

  • Yunnan Provincial Infectious Disease Hospital

    Kunming, Yunnan

  • The Third People's Hospital of Shenzhen

    Shenzhen, Guangdong, 518000

  • Subei People's Hospital of Jiangsu province

    Yangzhou, Jiangsu

Other trials in China

About this study

Official title: A Phase 2 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

The aim of this phase 2 study is to evaluate the safety and efficacy of single dose IV infusion of BRII-196 and BRII-198 given as combination therapy in patients with severe COVID-19, and mild to moderate COVID-19 and asymptomatic carrier.

Conditions
COVID-19
Being tested
BRII-196 and BRII-198, Placebo
Keywords
COVID-19 phase 2, monoclonal antibody
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BRII-196 and BRII-198Drug

    BRII-196 and BRII-198 given by intravenous administration

  • PlaceboDrug

    Placebo given by intravenous administration

Study groups in NCT04787211
Study groupRoleWhat they receive
BRII-196 and BRII-198 in adult subjects with severe COVID-19ExperimentalNot described
Receives: Drug: BRII-196 and BRII-198
BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19ExperimentalNot described
Receives: Drug: BRII-196 and BRII-198
Placebo in adult subjects with mild-moderate COVID-19ExperimentalNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Measured: Up to Day 181

  2. Incidence of serious adverse events (SAEs)

    Measured: Up to Day 181

  3. Change from pre-dose baseline in RBC count

    Measured: Day 29

  4. Change from pre-dose baseline in WBC count

    Measured: Day 29

  5. Change from pre-dose baseline in Platelets count

    Measured: Day 29

  6. Change from pre-dose baseline in Hemoglobin result

    Measured: Day 29

  7. Change from pre-dose baseline in Creatine kinase result

    Measured: Day 29

  8. Change from pre-dose baseline in Alanine aminotransferase (ALT) result

    Measured: Day 29

  9. Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8

    Measured: Day 8

Secondary outcomes (3)

  1. Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19

    Measured: up to Day 29

  2. Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization

    Measured: up to 26 weeks

  3. Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax)

    Measured: up to Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2021
  2. Study start20 Jun 2021
  3. Primary completion2 Dec 2021
  4. Study completion2 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04787211
Sponsor's protocol ID
BRII-196-198-004
Status last verified
Mar 2023
First submitted
4 Mar 2021
Last updated
3 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34473343

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BRII-196 and BRII-198 in people with COVID-19, run by Brii Biosciences Limited at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: Up to Day 181). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04787211, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.

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