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

NCT ID: NCT05012319

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2022-03-30

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).

Detailed Description

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

treatment arm

Nitric Oxide Nasal Spray "Enovid"

Group Type: EXPERIMENTAL

to be given as a treatment

Intervention Type: DRUG

Nitric Oxide Nasal Spray "Enovid"

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

to be given as a treatment

Intervention Type: DRUG

Nitric Oxide Nasal Spray "Enovid"

Interventions

to be given as a treatment

Nitric Oxide Nasal Spray "Enovid"

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 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)
• Sickle cell disease
• Immunocompromised such as HIV , cancer , on immunosuppressant medications

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salmaniya Medical Complex

OTHER_GOV

Sponsor Role: lead

Responsible Party

jameela al salman

infectious disease consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Abdulla Kanoo Center,

A'ali, Building 556, Bahrain

Site Status: RECRUITING

Countries

Bahrain

Central Contacts

jameela m alsalman, MD

Role: CONTACT

jsalman@health.gov.bh

0097336515138

Mariam alalawi, md

Role: CONTACT

malalawi31@hotmail.com

0097339960004

Facility Contacts

reem j ahmed

Role: primary

RAhmed4@health.gov.bh)

0097333731313

fatima alnashaba, md

Role: backup

0097333779876

Other Identifiers

COVIDTX-CTP-07

Identifier Type: -

Identifier Source: org_study_id