A Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal STI-2099 (COVI-DROPS™) as Treatment for COVID-19 Infection in Outpatient Adults
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Proportion of subjects who have a COVID-19-related visit or hospitalization
研究概览
简要总结
This is prospective double-blind study in the United States is designed to investigate the efficacy and safety of a single dose of COVI-DROPS or matched placebo in outpatient adults with mild symptoms associated with COVID-19 and a recent positive COVID-19 test.
详细描述
Subjects will be randomized 2:1 to receive a single dose of COVI-DROPS (40 mg) or placebo in a double-blind manner. Investigational product (COVI-DROP or placebo) will be administered once on Study Day 1 and followed to Day 29. Subjects will be stratified based upon prior history of infection or vaccination versus the group who is unvaccinated and not previously infected with COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment
- •Have mild illness/symptoms based upon NIH criteria. The NIH illness severity definition for "mild" states as follows: "Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging."
- •Be in good health as judged by investigator using screening medical history and physical examination. Participants who are otherwise healthy with a stable chronic medical condition may enroll
- •A prior COVID-19 infection in the past from which the subject fully recovered or a previously unknown asymptomatic infection is allowed, as is any previous COVID-19 vaccination
- •Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol
- •Subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity
- •Willing to follow contraception guidelines
排除标准
- •In the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours)
- •Currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to COVID-19 infection
- •Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection
- •Has an active documented infection other than COVID-19
- •Any medical condition that, in the Investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process
- •Pregnant or lactating women who are breast feeding or planning on either during the study
- •Has received within the 30 days prior to screening or is planning on receiving an EUA-cleared monoclonal antibody (mAb) during the study
- •Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, other non-EUA-cleared mAbs against COVID-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
研究组 & 干预措施
COVI-DROPS
40 mg of COVI-DROPS administered intranasally
干预措施: COVI-DROPS (Biological)
Placebo
2 mL placebo administered intranasally
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects who have a COVID-19-related visit or hospitalization
时间窗: Baseline through Day 29
Proportion of subjects with COVID-19-related urgent medically attended visits, emergency department assessments, hospitalizations ≥ 24h or all-cause death through Day 29 (D29)
次要结局
- Viral load change from baseline to Day 15 (D15)(Baseline through Day 15)
- Proportion of subjects who have a COVID-19-related visit or hospitalization based on stratification groups(Baseline to Day 29)