Study to Evaluate the Efficacy of COVID19-0001-USR in Patients With Mild/or Moderate COVID-19 Infection in Outpatient

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Drug: Drug COVID19-0001-USR
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 < 20. 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional study, randomized controlled, double-blind (i.e., active and passive control), 1 intervention group with investigative medicine, and a control group that will receive placebo intervention.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID19-0001-USR<br>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 | Drug: Drug COVID19-0001-USR<br>* COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2<br>* Other names: Nebulized;|
| Placebo Comparator: Normal Saline<br>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 | Drug: normal saline<br>* 0.9% NS via nebulization<br>* Other names: 0.9% NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on viral load results from baseline after using COVID19-0001-USR via nebulization | 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 | Treatment Period of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus Infections, COVID-19, SARS-COV-2