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.
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
Drug: Drug COVID19-0001-USR
COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2
Other Name: Nebulized
Drug: normal saline
0.9% NS via nebulization
Other Name: 0.9% NS
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
Cimedical
Barranquilla, Atlantico, Colombia
Investigator: Juan Jaller, MD
Contact: 57-5-345-0085
contacto@cimedical.co
Carlos A Riveros, MD
305-224-2201
Carlosrivg@gmail.com
Juan Jaller, MD
57-310-630-3530
juanjaller@cimedical.co