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

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ClinicalTrials.gov Identifier: NCT04595136
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
JUAN J JALLER-RAD, 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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: Drug COVID19-0001-USR Drug: normal saline Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, 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
Primary Purpose: Treatment
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
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Drug COVID19-0001-USR
COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2
Other Name: Nebulized

Placebo Comparator: 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
Drug: normal saline
0.9% NS via nebulization
Other Name: 0.9% NS




Primary Outcome Measures :
  1. Change on viral load results from baseline after using COVID19-0001-USR via nebulization [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595136


Contacts
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Contact: Carlos A Riveros, MD 305-224-2201 Carlosrivg@gmail.com
Contact: Juan Jaller, MD 57-310-630-3530 juanjaller@cimedical.co

Locations
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Colombia
Cimedical Recruiting
Barranquilla, Atlantico, Colombia
Contact: Juan Jaller, MD    57-5-345-0085    contacto@cimedical.co   
Contact: Viviana Fernandez, Nurse    57-5-345-0085    Vfernandez@Cimedical.co   
Sponsors and Collaborators
United Medical Specialties
Investigators
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Principal Investigator: Juan Jaller, MD United Medical Specialties
Study Director: Carlos A Riveros, MD United Medical Specialties
Additional Information:
Publications:

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Responsible Party: JUAN J JALLER-RAD, Principal Investigator, United Medical Specialties
ClinicalTrials.gov Identifier: NCT04595136    
Other Study ID Numbers: COVID19-0001-USR
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by JUAN J JALLER-RAD, United Medical Specialties:
Coronavirus Infections
COVID-19
SARS-COV-2
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases