Phase 3 Clinical Study Evaluating Nitric Oxide Nasal Spray (NONS) Efficacy To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Asymptomatic or Mild COVID-19

NCT05012319 | Unknown Phase 3 DMC

• 1 other identifier: COVIDTX-CTP-07
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Study Design: This is a double-blind, placebo-controlled, Phase 3 clinical efficacy study evaluating NONS in adult volunteers as a treatment for high-risk asymptomatic and symptomatic individuals with mild COVID-19 infection. thru facility).

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• efficacy of NONS compared to placebo in participants with COVID-19 to reduce the need of urgent care

  To evaluate the efficacy of NONS compared to placebo to reduce the need for urgent medical care in term of the need of visiting the emergency room in participants with COVID-19 infection and reduce of symptoms.

  6 months

Secondary Outcomes (4)

• efficacy of NONS compared to placebo in participants with COVID-19 to reduce mortality

  6 months

• efficacy of NONS compared to placebo in participants with COVID-19 on viral load reduction

  6 months

• efficacy of NONS compared to placebo in participants with COVID-19 to reduce time of clinical symptoms improvement

  6 months

• Incidence of Treatment-Emergent Adverse Events

  6 months

Study Arms (2)

treatment arm

EXPERIMENTAL

Nitric Oxide Nasal Spray "Enovid"

Drug: to be given as a treatment

Placebo

PLACEBO COMPARATOR

Placebo

Drug: to be given as a treatment

Interventions

to be given as a treatment DRUG

Nitric Oxide Nasal Spray "Enovid"

Placebo; treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and above.
• COVID-19 infection Confirmed with a laboratory SARS-CoV-2 RT-PCR nasal swab or antigen test. COVID-19 test specimen must be collected 48 hours prior to Screenings.
• Mild COVID-19 Infection defined as:
• No Pneumonia (negative by chest auscultation or Chest X Ray).
• No Shortness of breath.
• No Tachypnea (respiratory rate \<20 breathes/min)
• No Hypoxia (Oxygen saturation \>93% on RA)
• Fever \<38 degrees.
• No Chest Pain.
• No Mental Status Change.
• Asymptomatic participants must be high risk defined as (any of the following):
• Smokers (at least 5 cigarettes per day)
• BMI (\> 40 kg/m2)
• History of cardiac or chronic lung disease
• Clotting predisposing conditions (hemophilia, von Willebrand's disease)

You may not qualify if:

• Participants diagnosed with another (non-COVID-19) respiratory infection.
• Participants with a current tracheostomy or laryngectomy.
• Participants who are receiving concomitant respiratory therapy such as oxygen, positive airway pressure or ventilatory support. NOTE: Positive airway pressure for obstructive sleep apnea is permitted if the treatment was established with good compliance for at least 3 months before study enrollment.
• Participants with newly diagnosed illnesses that are not deemed stable by the participant's primary care physician), based on Investigator assessment of medical history during Screening.
• Participants who use intranasally dosed drugs, prescriptions or over-the-counter medications such as fluticasone.
• Participants who need hospitalization for reasons other than COVID-19 infection.
• Participants who are unable to safely self-administer the nasal spray as directed.
• Clinical signs indicative of moderate, severe, or critical COVID severity symptoms (requirement for supplemental oxygen, limitation of activities due to COVID-19 symptoms).
• Females who are breastfeeding, pregnant, or attempting to become pregnant.
• Participants who have experienced symptoms of COVID-19 for more than 7 days prior to randomization.
• Participants who have any other condition that, in the opinion of the Investigator, would interfere with a participant's ability to adhere to the protocol (eg, participants who are mentally or neurologically disabled and who are considered not fit for their participation in the study), interfere with assessment of the investigational product, or compromise the safety of the participant, or the quality of the data.

Sponsors & Collaborators

• Salmaniya Medical Complex: lead

Study Sites (1)

Abdulla Kanoo Center,

A'ali, Building 556, Bahrain

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

jameela m alsalman, MD

CONTACT

0097336515138; jsalman@health.gov.bh

Mariam alalawi, md

CONTACT

0097339960004; malalawi31@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: the list of the members of the resrach team who will be blinided have been identiifed and a full procedure has been identified
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: infectious disease consultant

Model Details: This is a randomized, double-blind, placebo-controlled, Phase 3 clinical efficacy study evaluating NONS in healthy adult volunteers as a treatment for high-risk asymptomatic and symptomatic individuals with mild COVID-19 infection.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 19, 2021
• Study Start: August 5, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

BA (1)