RecruitingNCT06042764Updated Dec 12, 2023

SA55 Injection Phase II Study in the Treatment of Mild/Moderate COVID-19 Patients

A Phase 2 interventional study of SA55 Injection in Infection of Upper Respiratory Tract Caused by 2019-nCoV, sponsored by Sinovac Life Sciences Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by Sinovac Life Sciences Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
Started Aug 2023; still recruiting 3 years 1 month later.

Phase: Phase 2
Study type: Interventional
Enrollment: 150
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Evaluating the efficacy and safety of SA55 injection in light/medium COVID-19 patients

Conditions studied

Infection of Upper Respiratory Tract Caused by 2019-nCoV

Keywords

2019-nCoV

In context

Lead sponsor

Sinovac Life Sciences Co., Ltd. is the lead sponsor of 26 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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;
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 150 participants (estimated)

Study arms

Experimental
SA55 Injection
Group 1: 300 mg Group 2: 600 mg
Drug: SA55 Injection
Placebo comparator
Placebo
Group 1: 0 mg Group 2: 0 mg
Drug: SA55 Injection

Interventions

DrugSA55 Injection
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)

What researchers measure

Primary outcomes

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
Time frame: from baseline to D3, D5, D7

Secondary outcomes

Evaluate the safety of SA55 injection in mild or moderate COVID-19 patients
The incidence of adverse events; The incidence of serious adverse events
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)
(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
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)
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
Time frame: 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.)
Time frame: 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.)
Time frame: an average of 1 year
Evaluating the immunogenicity of SA55 injection
Serum anti drug antibody (ADA) levels at different time points
Time frame: an average of 1 year

Study locations

1 of 1 sites recruiting

Ruijin Hospital
Shanghai, Shanghai 200025, China
- Guang Ning · Contact · guangning@medmail.com.cn · 13501656999
- Guang Ning, M.D. · Principal investigator
- Qing Xie, M.D. · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06042764
Lead sponsor: Sinovac Life Sciences Co., Ltd.
Responsible party: Sponsor
First posted: Sep 21, 2023
Start date: Aug 31, 2023
Primary completion: Mar 1, 2024 (estimated)
Completion: Aug 30, 2024 (estimated)
Last update: Dec 12, 2023

Study contacts

Guang Ning, M.D.

Contact

guangning@medmail.com.cn

13501656999

Guang Ning

principal investigator · Ruijin Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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