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

United Medical Specialties

Status and phase: Unknown; Phase 2; Phase 1

Conditions: SARS-CoV-2 Infection

Treatments: Drug: normal saline; Drug: Drug COVID19-0001-USR

Study type: Interventional

Funder types: Other

Identifiers

NCT04595136

COVID19-0001-USR

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

COVID19-0001-USR

Experimental group

Description:

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

Treatment:

Drug: Drug COVID19-0001-USR

Normal Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: normal saline