NCT04595136

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: United Medical Specialties · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	Drug COVID19-0001-USR	COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2
DRUG	normal saline	0.9% NS via nebulization

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-07-30
• Completion: 2021-08-30
• First posted: 2020-10-20
• Last updated: 2021-05-26

Locations

1 site across 1 country: Colombia