A Two-arm Randomized Double-blind Study With COVID19-0001-USR Administered Via Nebulization to Patients With Mild and/or Moderate Severe Acute Respiratory Syndrome (SARS-COV-2) Infection to Decrease Viral Load
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change on viral load results from baseline after using COVID19-0001-USR via nebulization
研究概览
简要总结
Determine the efficacy and safety of COVID19-0001-USR in the treatment of SARS-COV-2 infection in mild to moderate manifestations administered via nebulization/inhalation.
详细描述
This is an interventional, randomized controlled, double-blind study (i.e., active and passive control), 1 intervention group will be randomized with COVID 19-001-USR, and a control group to receive a placebo intervention to assess efficacy, tolerance, and decrease viral load and clinical manifestation on patients infected with SARS-COV-2. This will be a self-administered study drug 3 times a day for 7 days
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The mapping sequence will be hidden from the researcher by enrolling and evaluating participants in sequentially numbered, sealed, and stapled envelopes. To avoid the subversion of the allocation sequence, the name and date of birth of the participant will be written in the envelope, a second researcher verifies the process. The corresponding envelopes will be opened only after the enrolled participants complete all the reference assessments and assignment of the intervention by the protocol
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
- •Provide written consent before being included in the essay.
- •Positive cases of COVID-19 (based on polymerase chain reaction or positive antigen test for SARS-CoV-2),
- •Being diagnosed with mild to moderate SARS-COV-2 disease (COVID19)
- •Symptomatic or asymptomatic patient, with good clinical appearance, Sat O2 at rest > 94% with room air, and without desaturation with ambulation, and without tachypnea,
- •Respiratory rate <
- •Suspected cases of COVID-19, based on 3 criteria:
- •Fever > 38 Degrees Celsius
- •O2 saturation ≤94
- •Abnormal laboratory indicators, any of them:
- •Lymphopenia <1500 cells/m3
- •C reactive protein >2 mg/L
- •Ferritin >300g/L
排除标准
- •Existing decompensated conditions such as Diabetes Mellitus, Hypertension, Coronary Insufficiency, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease (or any chronic or severe lung disease), Chronic Kidney Disease, Cancer, Immunosuppression, Mood Change
- •Respiratory Frequency > 20 / min, Pulse > 120 bpm, systolic < 90 mmHg, diastolic < 60 mmHg
- •The patient seems toxic and distressed, or, O2 at rest <93% in ambient air, or desaturation when ambulating
- •Being diagnosed with severe SARS-COV-2 disease (COVID19)
- •Patients with low oxygen saturation levels, need for ICU entry, need or likelihood of invasive mechanical ventilation
- •Patients requiring bronchodilator treatment
- •Patients with a known history of asthma and/or lung disease
- •Patients with severe decompensated Chronic Obstructive Pulmonary Disease
- •Patients who are unable to give consent or who are unable to follow up on the test group will be excluded
研究组 & 干预措施
COVID19-0001-USR
Group 1 Patients with SARS-COV-2 (COVID19) positive test will receive Investigational Drug administer by nebulization ( COVID-19-0001-USR) Dosage: 3ml Frequency and Duration: Three times a day for 7 days
干预措施: Drug COVID19-0001-USR (Drug)
Normal Saline
Group 2 of patients with positive tests intervention SARS-COV-2 (COVID19) with placebo (i.e., normal saline 0.9% NS) plus standard baseline treatment for covid provided by Primary care provider ( Azithromycin, dexamethasone, and/or anticoagulants) Dosage: 3ml Frequency and Duration: Three times a day for 7 days
干预措施: normal saline (Drug)
结局指标
主要结局
Change on viral load results from baseline after using COVID19-0001-USR via nebulization
时间窗: Treatment Period of 7 days
COVID19-0001-USR 1% nebulized pathway changes viral load of SARS-COV-2 virus (COVID19) in the upper and lower airways if started during the initial phase of infection
次要结局
未报告次要终点
研究者
JUAN J JALLER-RAD
Principal Investigator
United Medical Specialties