COVID-19Phase 2NCT04931238
Efficacy and Safety of JS016 in Patients With SARS-CoV-2 Infection (COVID-19)
A Phase 2 study testing JS016 in people with COVID-19 and SARS-CoV-2, run by Peking Union Medical College Hospital at 4 sites in China.
Trial summary
The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- JS016
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- 20 Jan 2021to 31 Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) infection
- Within 7 days from the onset of clinical symptoms or 4 days from the onset of severe symptoms
- Consistent with the National Health Committee New Coronavirus pneumonia diagnosis and treatment plan (Eighth Edition), general or heavy diagnostic criteria.
Who cannot join
- Sever Covid-19 Infection patients
- SARS-Cov-2 specific antibodies (including IgM and IgG) were positive before included
- Cardiac function grade III or IV, or left ventricular ejection fraction < 30%
- History of known or suspected active pulmonary tuberculosis or extra-pulmonary tuberculosis
- Chronic renal failure needs maintenance dialysis
- History of solid malignant/tumor or hematological malignancy
- Pregnancy or lactation
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Li Weng
Beijing, Beijing Municipality, 100102
Li Weng, professor, 15601348897, wengli@gmail.com
Bin Du, professor, +8618600017819, dubin98@gmail.com
- Recruiting
The First Affliated Hospital of Harbin Medical University
Harbin, Hei Longjiang, 0451
Kaijiang Yu, MD, 010-13303608899, kaijiangyu002@163.com
Kaijiang Yu, MD
- Recruiting
Shi Jiazhuang People's Hospital
Shijiazhuang, Hebei
Qinying Cao, Prof., +86 13363882361, sjzcqy@126.com
Ling Cui, Master
- Recruiting
Suihua first hospital
Suihua, Hei Longjiang, 0455
Xinyang Zhang, Prof., +86 13804867215, xinshuang_1986@126.com
Xibin Wang, Prof.
About this study
Official title: Efficacy and Safety of a Recombinant Neutralizing Human Anti-SARS-CoV-2 Monoclonal Antibody JS016 in Chinese Hospitalized Patients With SARS-CoV-2 Infection (COVID-19): a Multicenter, Randomized, Open-label, Controlled Trial
The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19.
Read the detailed description
As the COVID-19 pandemic is emerging as a global healthcare crisis, scientists worldwide are actively developing prophylactic and therapeutic interventions. Neutralizing antibody therapies are being developed for the treatment of COVID-19. The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. The LALA mutation was introduced to the Fc portion of CB6 (CB6-LALA) to lower the risk of Fc-mediated acute lung injury in animals. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19. The data from this study will inform decisions of the clinical use of JS016.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- JS016
- Keywords
- COVID-19, JS016, spike (S) protein, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS016Drug
Also called CB6-LALA
Single Intravenous Injection of JS016 with a dose of 50mg/kg
| Study group | Role | What they receive |
|---|---|---|
| JS016 treatment group | Experimental | Standard therapy + JS016 injection Standard therapy including vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition. Receives: Drug: JS016 |
| Control group | No intervention | Standard therapy Standard therapy includes vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical status at 28 days
Clinical status at 28 days assessed using a six level ordinal scale，in this scale, 1 is the minimum score and presenting a better outcome as discharge, 2 means still in-hospital but no need of oxygen therapy, 3 presents in-hospital and needing of oxygen therapy, 4 presents in-hospital needing high flow nasal oxygen therapy or non-invasive mechanical ventilation, 5 presents in-hospital needing invasive mechanical ventilation or ECMO, 6 presents death and is the worse outcome as well.
Measured: At 28 days from inclusion
Secondary outcomes (4)
All cause mortality ascertained from data analysed to day 28
All cause mortality ascertained from data analysed to day 28
Measured: At 28 days from inclusion
Ventilator-free days within 28 days
Ventilator-free days within 28 days
Measured: At 28 days from inclusion
Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after randomization
Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after
Measured: At 14 days from inclusion
Average length of hospital stay
Average length of hospital stay
Measured: At 28 days from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start20 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin DU, Prof., Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931238
- Sponsor's protocol ID
- Peking JS016
- Status last verified
- Oct 2021
- First submitted
- 13 Jun 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang L, Liu W, Yu X, Wu M, Reichert JM, Ho M. COVID-19 antibody therapeutics tracker: a global online database of antibody therapeutics for the prevention and treatment of COVID-19. Antib Ther. 2020 Jul;3(3):205-212. doi: 10.1093/abt/tbaa020. Epub 2020 Aug 19.
PubMed 33215063Hirsch 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.
PubMed 35713300Dong R, Jiang L, Yang T, Wang C, Zhang Y, Chen X, Xie J, Guo Y, Weng L, Kang Y, Yu K, Qiu H, Du B; China Critical Care Clinical Trials Group (CCCCTG). Efficacy and Safety of SARS-CoV-2 Neutralizing Antibody JS016 in Hospitalized Chinese Patients with COVID-19: a Phase 2/3, Multicenter, Randomized, Open-Label, Controlled Trial. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0204521. doi: 10.1128/AAC.02045-21. Epub 2022 Mar 15.
PubMed 35191746
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Recombinant Neutralizing Human Anti-SARS-CoV-2 Monoclonal Antibody JS016 in Chinese Hospitalized Patients With SARS-CoV-2 Infection (COVID-19): a Multicenter, Randomized, Open-label, Controlled Trial
- ClinicalTrials.gov ID
- NCT04931238
- Acronym / sponsor ID
- Peking JS016
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- COVID-19, JS016, spike (S) protein, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jun 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.
The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19.
Detailed description
As the COVID-19 pandemic is emerging as a global healthcare crisis, scientists worldwide are actively developing prophylactic and therapeutic interventions. Neutralizing antibody therapies are being developed for the treatment of COVID-19. The human monoclonal antibody CB6 showed potent neutralization activity in vitro against SARS-CoV-2. The LALA mutation was introduced to the Fc portion of CB6 (CB6-LALA) to lower the risk of Fc-mediated acute lung injury in animals. CB6-LALA (also called JS016) has been developed for clinical use. Phase I trials among healthy volunteers has demonstrated a tolerable and safe drug profile of JS016. We aim to evaluate the efficacy and safety of JS016 in patients hospitalized with COVID-19. The data from this study will inform decisions of the clinical use of JS016.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS016 treatment group | Experimental | Drug: JS016Standard therapy + JS016 injection Standard therapy including vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition. |
| Control group | No intervention | –Standard therapy Standard therapy includes vital sign monitoring, supplementary oxygen and respiratory support in accordance with the patient's oxygen saturation and respiratory condition. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) infection
- Within 7 days from the onset of clinical symptoms or 4 days from the onset of severe symptoms
- Consistent with the National Health Committee New Coronavirus pneumonia diagnosis and treatment plan (Eighth Edition), general or heavy diagnostic criteria.
Key exclusion criteria (7 listed)
- Sever Covid-19 Infection patients
- SARS-Cov-2 specific antibodies (including IgM and IgG) were positive before included
- Cardiac function grade III or IV, or left ventricular ejection fraction < 30%
- History of known or suspected active pulmonary tuberculosis or extra-pulmonary tuberculosis
- Chronic renal failure needs maintenance dialysis
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 |
|---|---|---|
| JS016Also: CB6-LALASingle Intravenous Injection of JS016 with a dose of 50mg/kg | Drug | JS016 treatment group |
Primary outcome
Clinical status at 28 days
Time frame: At 28 days from inclusion
Clinical status at 28 days assessed using a six level ordinal scale，in this scale, 1 is the minimum score and presenting a better outcome as discharge, 2 means still in-hospital but no need of oxygen therapy, 3 presents in-hospital and needing of oxygen therapy, 4 presents in-hospital needing high flow nasal oxygen therapy or non-invasive mechanical ventilation, 5 presents in-hospital needing invasive mechanical ventilation or ECMO, 6 presents death and is the worse outcome as well.
4 secondary outcomes
All cause mortality ascertained from data analysed to day 28
Time frame: At 28 days from inclusion
Ventilator-free days within 28 days
Time frame: At 28 days from inclusion
Negative conversion rate of SARS-CoV-2 nucleic acid in on days 14 after randomization
Time frame: At 14 days from inclusion
Average length of hospital stay
Time frame: At 28 days from inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Results publication: PubMed 33215063Yang L, Liu W, Yu X, Wu M, Reichert JM, Ho M. COVID-19 antibody therapeutics tracker: a global online database of antibody therapeutics for the prevention and treatment of COVID-19. Antib Ther. 2020 Jul;3(3):205-212. doi: 10.1093/abt/tbaa020. Epub 2020 Aug 19.
- Derived from this study: PubMed 35713300Hirsch 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.
- Derived from this study: PubMed 35191746Dong R, Jiang L, Yang T, Wang C, Zhang Y, Chen X, Xie J, Guo Y, Weng L, Kang Y, Yu K, Qiu H, Du B; China Critical Care Clinical Trials Group (CCCCTG). Efficacy and Safety of SARS-CoV-2 Neutralizing Antibody JS016 in Hospitalized Chinese Patients with COVID-19: a Phase 2/3, Multicenter, Randomized, Open-Label, Controlled Trial. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0204521. doi: 10.1128/AAC.02045-21. Epub 2022 Mar 15.
- Individual participant dataSharing planned: No
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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.
Bin DU, Prof. study chair
Peking Union Medical College Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JS016 in people with COVID-19 and SARS-CoV-2, run by Peking Union Medical College Hospital at 4 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 7 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: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin DU, Prof. (+86 13601366216, dubin98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical status at 28 days (time frame: At 28 days from inclusion). 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 NCT04931238, which also lists 3 linked publications.
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 21 Oct 2021.