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

May 21, 2021 updated by: JUAN J JALLER-RAD, United Medical Specialties

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 0.9% NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Treatment Period of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Medical Specialties

Investigators

  • Principal Investigator: Juan Jaller, MD, United Medical Specialties
  • Study Director: Carlos A Riveros, MD, United Medical Specialties

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Anticipated)

July 30, 2021

Study Completion (Anticipated)

August 30, 2021

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID19-0001-USR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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