Clinical trial NCT04595136: Study to Evaluate the Efficacy of COVID19-0001-USR in Patients With Mild/or Moderate COVID-19 Infection in Outpatient
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: SARS-CoV-2 Infection
Keywords: Coronavirus Infections
COVID-19
SARS-COV-2
Lead sponsor: United Medical Specialties
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change on viral load results from baseline after using COVID19-0001-USR via nebulization
timeFrame: Treatment Period of 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Cimedical
state: Atlantico
Study officials:
affiliation: United Medical Specialties
name: Juan Jaller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: United Medical Specialties
name: Carlos A Riveros, MD
role: STUDY_DIRECTOR
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