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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)

Primary Purpose

SARS-CoV-2 Infection

Status

Unknown status

Phase

Phase 1

Locations

Colombia

Study Type

Interventional

Intervention

Drug COVID19-0001-USR

normal saline

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring Coronavirus Infections, COVID-19, SARS-COV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CimedicalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVID19-0001-USR

Normal Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change on viral load results from baseline after using COVID19-0001-USR via nebulization

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04595136

First Posted

October 15, 2020

Last Updated

May 21, 2021

Sponsor

United Medical Specialties

1. Study Identification

Unique Protocol Identification Number

NCT04595136

Brief Title

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

Acronym

COVID-19

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 2, 2020 (Actual)

Primary Completion Date

July 30, 2021 (Anticipated)

Study Completion Date

August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

United Medical Specialties

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV-2 Infection

Keywords

Coronavirus Infections, COVID-19, SARS-COV-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigator

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

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COVID19-0001-USR

Arm Type

Experimental

Arm Description

Arm Title

Normal Saline

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Drug COVID19-0001-USR

Other Intervention Name(s)

Nebulized

Intervention Description

COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2

Intervention Type

Drug

Intervention Name(s)

normal saline

Other Intervention Name(s)

0.9% NS

Intervention Description

0.9% NS via nebulization

Primary Outcome Measure Information:

Title

Change on viral load results from baseline after using COVID19-0001-USR via nebulization

Description

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

Time Frame

Treatment Period of 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carlos A Riveros, MD

Phone

305-224-2201

Carlosrivg@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Juan Jaller, MD

Phone

57-310-630-3530

juanjaller@cimedical.co

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan Jaller, MD

Organizational Affiliation

United Medical Specialties

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carlos A Riveros, MD

Organizational Affiliation

United Medical Specialties

Official's Role

Study Director

Facility Information:

Facility Name

Cimedical

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan Jaller, MD

Phone

57-5-345-0085

contacto@cimedical.co

First Name & Middle Initial & Last Name & Degree

Viviana Fernandez, Nurse

Phone

57-5-345-0085

Vfernandez@Cimedical.co

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32779815

Citation

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Results Reference

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32132196

Citation

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.

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Links:

URL

https://www.researchsquare.com/article/rs-64501/v1

Description

Nebulized ivermectin for COVID-19 and other respiratory diseases, a proof of concept, dose-ranging study in rats

Learn more about this trial

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

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