SARS-CoV-2 Infection
Conditions
Keywords
Coronavirus Infections, COVID-19, SARS-COV-2
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
Interventions
DRUGDrug COVID19-0001-USR
COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2
DRUGnormal saline
0.9% NS via nebulization
Sponsors
United Medical Specialties
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The mapping sequence will be hidden from the researcher by enrolling and evaluating participants in sequentially numbered, sealed, and stapled envelopes. To avoid the subversion of the allocation sequence, the name and date of birth of the participant will be written in the envelope, a second researcher verifies the process. The corresponding envelopes will be opened only after the enrolled participants complete all the reference assessments and assignment of the intervention by the protocol
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Colombia
Contacts
Primary ContactCarlos A Riveros, MD
Backup ContactJuan Jaller, MD
Outcome results
None listed