Sodium Pyruvate Nasal Spray Treatment of COVID-19 and Influenza Infections
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04824365|
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Influenza||Drug: Sodium Pyruvate Other: Saline||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||15 patients will be assigned to the placebo and 15 patients assigned to the drug treatment for both COVID19 and influenza group, for a total of 60 patients.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Two Week Sub-chronic Double-blinded Placebo Controlled Trial Designed to Determine if Sodium Pyruvate Nasal Spray Will Reduce the Symptoms, Duration and Replication of COVID-19 and Influenza Infections|
|Actual Study Start Date :||April 12, 2021|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: treatment of COVID-19 or influenza infected patients with a sodium pyruvate nasal spray
In this arm, patients will be provided with N115 sodium pyruvate nasal spray and instructed to use it 3x daily for 14 days. This group will be compared to the placebo control group to determine if sodium pyruvate reduces the symptoms, duration and replication of COVIV-19 and influenza infections.
Drug: Sodium Pyruvate
Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
Other Name: N115
Placebo Comparator: Placebo control treatment of COVID-19 or influenza infected patients
In this arm, patients will be provided with a saline nasal spray as a placebo control. Patients will use the saline nasal spray 3x daily for 14 days, similar to the sodium pyruvate drug arm. This will serve as a control for the symptoms, duration and replication of COVIV-19 and influenza infections.
Subjects will use a saline nasal spray 3x daily for 14 days.
- Evaluate the ability of inhaled nasal sodium pyruvate to change COVID-19 or influenza viral titers. [ Time Frame: 14 days ]RT-PCR will be used to assess viral titers from nasal swabs from COVID19 or influenza patients. Swabs will be collected and tested every 2 days for 14 days or until negative.
- Evaluate the ability of inhaled nasal sodium pyruvate to change the symptoms of COVID-19 or influenza. [ Time Frame: 14 days ]To evaluate the ability of the nasal spray to improve the symptoms from COVID19 or influenza, a patient log will be used. Signs and symptoms to be logged include fever, body ache, headache, chills, coughing/sneezing, sore throat, congestion, trouble breathing and other (patient supplied). Patients will use a Likert scales from 1 to 10 to assess signs and symptoms, except for fever, which will be recorded as temperature in degrees Fahrenheit. Blood pressure and pulse/Ox will be collected every 2 days by a nurse or PA at the time of nasal swab collection.
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): NCT04824365
|Contact: Christopher lupfer, Ph.D.||901 461 9215||Christopherlupfer@MissouriState.edu|
|Contact: Alain Martin, Ph.D.||908 237 firstname.lastname@example.org|
|United States, Florida|
|Family First Medical Research Center||Recruiting|
|Virginia Gardens, Florida, United States, 33166|
|Contact: Manuel M Lam, MD 786-665-9374 email@example.com|
|Contact: Barbara Rordriguez, ARPN 786-665-9374 firstname.lastname@example.org|
|United States, Missouri|
|Missouri State University||Recruiting|
|Springfield, Missouri, United States, 65897|
|Contact: Christopher Lupfer, Ph.D. 417-836-6887 Christopherlupfer@MissouriState.edu|
|Contact: Alain Martin 9082371561 email@example.com|
|Principal Investigator: Christopher lupfer, Ph.D.|
|Study Director:||Ronald Amen, Ph.D.||VP of Regulatory affairs|