Infection of Upper Respiratory Tract Caused by 2019-nCoVPhase 2NCT06042764
SA55 Injection Phase II Study in the Treatment of Mild/Moderate COVID-19 Patients
A Phase 2 study testing SA55 Injection in people with Infection of Upper Respiratory Tract Caused by 2019-nCoV, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
Trial summary
Evaluating the efficacy and safety of SA55 injection in light/medium COVID-19 patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection of Upper Respiratory Tract Caused by 2019-nCoV
- What is being tested?
- SA55 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2023to 30 Aug 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 years on the day of enrollment;
- On the day of enrollment, novel coronavirus nucleic acid test was positive and/or novel coronavirus antigen test was positive;
- On the day of enrollment, it meets the criteria for mild or medium COVID-19 cases, and the time from the first COVID-19 infection related symptoms is within 72 hours;
- Within 24 hours before enrollment, one or more of the following symptoms or signs must be present: a. fever, b. cough, c. sore throat, d. nasal congestion/runny nose, e. headache, f. muscle pain, g. shortness of breath/difficulty breathing, h. nausea, i. fatigue, j. vomiting, k. diarrhea;
- Subjects (male and female of childbearing age) and their sexual partners voluntarily take effective contraceptive measures within 6 months after signing the informed consent form and administering the experimental drug, and do not have plans to donate sperm or eggs;
- At rest, when inhaling air, the oxygen saturation is greater than 93%;
- Subjects voluntarily participate in the experiment and sign an informed consent form before the start of the study.
Who cannot join
- Individuals who are known to be allergic to the investigational drug, any component in the preparation, or other similar drugs;
- Individuals weighing less than 40 kg;
- There are comorbidities that require surgery within one month, or comorbidities that are considered life-threatening within one month;
- Before screening, he has received neutralizing antibody drugs from COVID-19, or received human immunoglobulin or convalescent plasma treatment from convalescent patients within 3 months, or received small molecule drugs from COVID-19 within 7 days;
- Suspected or confirmed to have combined serious and active bacterial, fungal, viral or other infections (except for COVID-19 infection), such as acute systemic infection, the researcher believes that intervention measures may pose a risk;
- Individuals who tested positive for influenza A/B virus antigens during screening;
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- Plan to become pregnant within 6 months, already pregnant, or breastfeeding;
- Participated in clinical trials of other drugs or medical devices within 3 months prior to screening;
- Having/having suffered from severe neurological disorders (epilepsy, convulsions, or seizures) or mental illness, or having a family history of mental illness;
- Suffering from/having previously suffered from severe neurological diseases or other serious illnesses that the researcher has determined to be unsuitable for participation in the study (including but not limited to current systemic infections, uncontrolled autoimmune diseases, uncontrolled immunodeficiency diseases, history of myocardial infarction or heart disease, etc.);
- Unable to cooperate with the follow-up of the study, or unable to guarantee the non use of concomitant drugs/vaccines/treatments prohibited by this protocol during the study period (see section 6.4.2);
- The researcher believes that due to other reasons, it is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Guang Ning, 13501656999, guangning@medmail.com.cn
Guang Ning, M.D.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Novel Coronavirus Broad-spectrum Neutralizing Antibody SA55 Injection in the Treatment of Mild/Moderate COVID-19 Patients
Evaluating the efficacy and safety of SA55 injection in light/medium COVID-19 patients
- Being tested
- SA55 Injection
- Keywords
- 2019-nCoV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA55 InjectionDrug
Novel coronavirus broad-spectrum neutralizing antibody SA55 injection (SA55 injection) is developed and produced by Beijing Kexing Zhongwei Biologics Technology Co., Ltd. The main component of SA55 injection is novel coronavirus broad-spectrum neutralizing antibody SA55. Each milliliter contains 150 mg of novel coronavirus broad-spectrum neutralizing antibody SA55. Excipients include histidine hydrochloride, arginine hydrochloride, histidine hydrochloride, sucrose, and polysorbate 80 (II)
| Study group | Role | What they receive |
|---|---|---|
| SA55 Injection | Experimental | Group 1: 300 mg Group 2: 600 mg Receives: Drug: SA55 Injection |
| Placebo | Placebo comparator | Group 1: 0 mg Group 2: 0 mg Receives: Drug: SA55 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients
Changes of novel coronavirus (SARS-CoV-2) load from baseline to D3, D5, D7
Measured: from baseline to D3, D5, D7
Secondary outcomes (6)
Evaluate the safety of SA55 injection in mild or moderate COVID-19 patients
The incidence of adverse events; The incidence of serious adverse events
Measured: an average of 1 year
Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (impact on virological indicators)
(1) Changes in SARS-CoV-2 virus load relative to baseline at different time points; (2) Time to achieve continuous negative conversion of SARS-CoV-2 nucleic acid; (3) The proportion of subjects who achieved continuous negative SARS-CoV-2 nucleic acid conversion at different time points
Measured: (1) D9, D11, D15 (2) After administration (3) D3, D5, D7, D9, D11, D15
Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (impact on clinical indicators)
Within 28 days after administration: the time of continuous disappearance of clinical symptoms and the time of continuous remission of clinical symptoms of 5, 7 and 11 COVID-19; The proportion of subjects who progress to severe/critically ill conditions; Hospitalization rate due to COVID-19; All cause mortality rate; Rescue treatment rate; Change of clinical symptom score of COVID-19 from baseline to different time points
Measured: an average of 1 year
Evaluate the pharmacokinetic characteristics of SA55 injection in mild or moderate COVID-19 patients
Serum pharmacokinetic parameters of SA55 after medication (peak time Tmax, peak concentration Cmax, area under the drug time curve AUC0-t, AUC0- ∞, elimination half-life t1/2, apparent clearance rate CL/F, apparent distribution volume Vd/F, etc.)
Measured: an average of 1 year
Evaluation of serum COVID-19 neutralizing activity at different time points
Serum pharmacokinetic parameters of SA55 after medication (peak time Tmax, peak concentration Cmax, area under the drug time curve AUC0-t, AUC0- ∞, elimination half-life t1/2, apparent clearance rate CL/F, apparent distribution volume Vd/F, etc.)
Measured: an average of 1 year
Evaluating the immunogenicity of SA55 injection
Serum anti drug antibody (ADA) levels at different time points
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start31 Aug 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection of Upper Respiratory Tract Caused by 2019-nCoVStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guang Ning, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042764
- Sponsor's protocol ID
- PRO-SA55-2001
- Status last verified
- Dec 2023
- First submitted
- 26 Aug 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of Novel Coronavirus Broad-spectrum Neutralizing Antibody SA55 Injection in the Treatment of Mild/Moderate COVID-19 Patients
- ClinicalTrials.gov ID
- NCT06042764
- Acronym / sponsor ID
- PRO-SA55-2001
- Keywords
- 2019-nCoV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
Evaluating the efficacy and safety of SA55 injection in light/medium COVID-19 patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SA55 Injection | Experimental | Drug: SA55 InjectionGroup 1: 300 mg Group 2: 600 mg |
| Placebo | Placebo comparator | Drug: SA55 InjectionGroup 1: 0 mg Group 2: 0 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged ≥ 18 years on the day of enrollment;
- On the day of enrollment, novel coronavirus nucleic acid test was positive and/or novel coronavirus antigen test was positive;
- On the day of enrollment, it meets the criteria for mild or medium COVID-19 cases, and the time from the first COVID-19 infection related symptoms is within 72 hours;
- Within 24 hours before enrollment, one or more of the following symptoms or signs must be present: a. fever, b. cough, c. sore throat, d. nasal congestion/runny nose, e. headache, f. muscle pain, g. shortness of breath/difficulty breathing, h. nausea, i. fatigue, j. vomiting, k. diarrhea;
- Subjects (male and female of childbearing age) and their sexual partners voluntarily take effective contraceptive measures within 6 months after signing the informed consent form and administering the experimental drug, and do not have plans to donate sperm or eggs;
Key exclusion criteria (12 listed)
- Individuals who are known to be allergic to the investigational drug, any component in the preparation, or other similar drugs;
- Individuals weighing less than 40 kg;
- There are comorbidities that require surgery within one month, or comorbidities that are considered life-threatening within one month;
- Before screening, he has received neutralizing antibody drugs from COVID-19, or received human immunoglobulin or convalescent plasma treatment from convalescent patients within 3 months, or received small molecule drugs from COVID-19 within 7 days;
- Suspected or confirmed to have combined serious and active bacterial, fungal, viral or other infections (except for COVID-19 infection), such as acute systemic infection, the researcher believes that intervention measures may pose a risk;
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 |
|---|---|---|
| SA55 InjectionNovel coronavirus broad-spectrum neutralizing antibody SA55 injection (SA55 injection) is developed and produced by Beijing Kexing Zhongwei Biologics Technology Co., Ltd. The main component of SA55 injection is novel coronavirus broad-spectrum neutralizing antibody SA55. Each milliliter contains 150 mg of novel coronavirus broad-spectrum neutralizing antibody SA55. Excipients include histidine hydrochloride, arginine hydrochloride, histidine hydrochloride, sucrose, and polysorbate 80 (II) | Drug | Placebo, SA55 Injection |
Primary outcome
Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients
Time frame: from baseline to D3, D5, D7
Changes of novel coronavirus (SARS-CoV-2) load from baseline to D3, D5, D7
6 secondary outcomes
Evaluate the safety of SA55 injection in mild or moderate COVID-19 patients
Time frame: an average of 1 year
Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (impact on virological indicators)
Time frame: (1) D9, D11, D15 (2) After administration (3) D3, D5, D7, D9, D11, D15
Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (impact on clinical indicators)
Time frame: an average of 1 year
Evaluate the pharmacokinetic characteristics of SA55 injection in mild or moderate COVID-19 patients
Time frame: an average of 1 year
Evaluation of serum COVID-19 neutralizing activity at different time points
Time frame: an average of 1 year
Evaluating the immunogenicity of SA55 injection
Time frame: an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: Undecided
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.
Guang Ning principal investigator
Ruijin Hospital
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 SA55 Injection in people with Infection of Upper Respiratory Tract Caused by 2019-nCoV, run by Sinovac Life Sciences Co., Ltd. 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 7 inclusion and 12 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 12 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guang Ning, M.D. (13501656999, guangning@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (time frame: from baseline to D3, D5, D7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2023.