COVID-19Phase 2NCT04770467
A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19
A Phase 2 study testing BRII-196 and BRII-198 in people with COVID-19, run by Brii Biosciences, Inc. at 1 site in China.
Trial 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. 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
- 0 participants
- Where
- 1 siteChina
- Study dates
- Feb 2021to Oct 2022
- 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
1 site in 1 country.
About this study
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
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.
- 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 group | Role | What they receive |
|---|---|---|
| BRII-196 and BRII-198 in adult subjects with severe COVID-19 | Experimental | Not described Receives: Drug: BRII-196 and BRII-198 |
| Placebo in adult subjects with severe COVID-19 | Placebo comparator | Not described Receives: Drug: Placebo |
| BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19 | Experimental | Not described Receives: Drug: BRII-196 and BRII-198 |
| Placebo in adult subjects with mild-moderate COVID-19 | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Day 29
Incidence of serious adverse events (SAEs)
Measured: up to Day 29
Change from pre-dose baseline in RBC count
Measured: Day 29
Change from pre-dose baseline in WBC count
Measured: Day 29
Change from pre-dose baseline in Platelets count
Measured: Day 29
Change from pre-dose baseline in Hemoglobin result
Measured: Day 29
Change from pre-dose baseline in Creatine kinase result
Measured: Day 29
Change from pre-dose baseline in Alanine aminotransferase (ALT) result
Measured: Day 29
Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8
Measured: Day 8
Secondary outcomes (3)
Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19
Measured: up to Day 29
Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization
Measured: up to 72 weeks
Assessment of PK parameters: 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.
- First posted25 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: The study will no longer move forward due to recent changes in COVID-19 cases in Hong Kong.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brii Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yao Zhang, MD, Study director, Brii Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770467
- Sponsor's protocol ID
- BRII-196-198-002
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04770467
- Acronym / sponsor ID
- BRII-196-198-002
- Conditions
- COVID-19
- Keywords
- COVID-19 phase 2, monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study will no longer move forward due to recent changes in COVID-19 cases in Hong Kong.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brii Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BRII-196 and BRII-198 in adult subjects with severe COVID-19 | Experimental | Drug: BRII-196 and BRII-198 |
| Placebo in adult subjects with severe COVID-19 | Placebo comparator | Drug: Placebo |
| BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19 | Experimental | Drug: BRII-196 and BRII-198 |
| Placebo in adult subjects with mild-moderate COVID-19 | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRII-196 and BRII-198BRII-196 and BRII-198 given by intravenous administration | Drug | BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19, BRII-196 and BRII-198 in adult subjects with severe COVID-19 |
| PlaceboPlacebo given by intravenous administration | Drug | Placebo in adult subjects with mild-moderate COVID-19, Placebo in adult subjects with severe COVID-19 |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Day 29
Incidence of serious adverse events (SAEs)
Time frame: up to Day 29
Change from pre-dose baseline in RBC count
Time frame: Day 29
Change from pre-dose baseline in WBC count
Time frame: Day 29
Change from pre-dose baseline in Platelets count
Time frame: Day 29
Change from pre-dose baseline in Hemoglobin result
Time frame: Day 29
Change from pre-dose baseline in Creatine kinase result
Time frame: Day 29
Change from pre-dose baseline in Alanine aminotransferase (ALT) result
Time frame: Day 29
Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8
Time frame: Day 8
3 secondary outcomes
Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19
Time frame: up to Day 29
Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization
Time frame: up to 72 weeks
Assessment of PK parameters: maximum serum concentration observed (Cmax)
Time frame: up to Day 85
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Derived from this study: PubMed 34473343Kreuzberger 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.
Related trials for COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Zhang, MD study director
Brii Biosciences, Inc.
1 site in 1 country: see every site and its status.
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, Inc. at 1 site 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: withdrawn, 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 1 site 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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: Day 29). 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 NCT04770467, 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; AzTrials last refreshed its copy on 8 Nov 2026.