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

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ClinicalTrials.gov Identifier: NCT06042764
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : December 12, 2023
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Life Sciences Co., Ltd. )

Study Description
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Brief Summary:
Evaluating the efficacy and safety of SA55 injection in light/medium COVID-19 patients

Condition or disease Intervention/treatment Phase
Infection of Upper Respiratory Tract Caused by 2019-nCoV Drug: SA55 Injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 31, 2023
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SA55 Injection
Group 1: 300 mg Group 2: 600 mg
 Drug: SA55 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)
Placebo Comparator: Placebo
Group 1: 0 mg Group 2: 0 mg
 Drug: SA55 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Evaluate the safety of SA55 injection in mild or moderate COVID-19 patients [ Time Frame: an average of 1 year ]
    The incidence of adverse events; The incidence of serious adverse events

  2. 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 ]
    (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

  3. 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 ]
    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

  4. Evaluate the pharmacokinetic characteristics of SA55 injection in mild or moderate COVID-19 patients [ Time Frame: an average of 1 year ]
    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.)

  5. Evaluation of serum COVID-19 neutralizing activity at different time points [ Time Frame: an average of 1 year ]
    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.)

  6. Evaluating the immunogenicity of SA55 injection [ Time Frame: an average of 1 year ]
    Serum anti drug antibody (ADA) levels at different time points


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06042764


Contacts
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Contact: Guang Ning, M.D. 13501656999 guangning@medmail.com.cn

Locations
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China, Shanghai
Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Guang Ning    13501656999    guangning@medmail.com.cn   
Principal Investigator: Guang Ning, M.D.         
Principal Investigator: Qing Xie, M.D.         
Sponsors and Collaborators
Sinovac Life Sciences Co., Ltd.
Investigators
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Principal Investigator: Guang Ning Ruijin Hospital
More Information
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Responsible Party: Sinovac Life Sciences Co., Ltd.
ClinicalTrials.gov Identifier: NCT06042764    
Other Study ID Numbers: PRO-SA55-2001
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sinovac Biotech Co., Ltd ( Sinovac Life Sciences Co., Ltd. ):
2019-nCoV