Clinical trial NCT06042764: SA55 Injection Phase II Study in the Treatment of Mild/Moderate COVID-19 Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Infection of Upper Respiratory Tract Caused by 2019-nCoV
Keywords: 2019-nCoV
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients
timeFrame: from baseline to D3, D5, D7
Secondary outcomes:
measure: Evaluate the safety of SA55 injection in mild or moderate COVID-19 patients
timeFrame: an average of 1 year
measure: Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (impact on virological indicators)
timeFrame: (1) D9, D11, D15 (2) After administration (3) D3, D5, D7, D9, D11, D15
measure: Evaluation of the efficacy of SA55 injection in mild or moderate COVID-19 patients (impact on clinical indicators)
timeFrame: an average of 1 year
measure: Evaluate the pharmacokinetic characteristics of SA55 injection in mild or moderate COVID-19 patients
timeFrame: an average of 1 year
measure: Evaluation of serum COVID-19 neutralizing activity at different time points
timeFrame: an average of 1 year
measure: Evaluating the immunogenicity of SA55 injection
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Guang Ning
role: PRINCIPAL_INVESTIGATOR
References: