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

NCT06042764 | Unknown Phase 2

• 1 other identifier: PRO-SA55-2001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infection of Upper Respiratory Tract Caused by 2019-nCoV

Keywords

2019-nCoV

Outcome Measures

Primary Outcomes (1)

• 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

  from baseline to D3, D5, D7

Secondary Outcomes (6)

• Evaluate the safety of SA55 injection in mild or moderate COVID-19 patients

  an average of 1 year

• Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (impact on virological indicators)

  (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)

  an average of 1 year

• Evaluate the pharmacokinetic characteristics of SA55 injection in mild or moderate COVID-19 patients

  an average of 1 year

• Evaluation of serum COVID-19 neutralizing activity at different time points

  an average of 1 year

Study Arms (2)

SA55 Injection

EXPERIMENTAL

Group 1: 300 mg Group 2: 600 mg

Drug: SA55 Injection

Placebo

PLACEBO COMPARATOR

Group 1: 0 mg Group 2: 0 mg

Drug: SA55 Injection

Interventions

SA55 Injection DRUG

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; SA55 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Study Officials

• Guang Ning

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Ning, M.D.

CONTACT

13501656999; guangning@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 21, 2023
• Study Start: August 31, 2023
• Primary Completion: March 1, 2024
• Study Completion: August 30, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

CN (1)