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

Phase 1

• Conditions: SARS-CoV-2 Infection
• Interventions: Drug: Drug COVID19-0001-USR; Drug: normal saline

• Registration Number: NCT04595136
• Lead Sponsor: United Medical Specialties

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Study Start: 2020-11-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-26
• Primary Completion: 2021-07-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVID19-0001-USR	Drug 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
Normal Saline	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

Primary Outcome Measures

Name	Time	Method
Change on viral load results from baseline after using COVID19-0001-USR via nebulization	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

Trial Locations

Locations (1)

Cimedical; 🇨🇴 Barranquilla, Atlantico, Colombia