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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: to be given as a treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: jameela m alsalman, MD; Phone Number: 0097336515138; Email: jsalman@health.gov.bh
• Study Contact Backup: Name: Mariam alalawi, md; Phone Number: 0097339960004; Email: malalawi31@hotmail.com

Study Locations

• Bahrain
  • Building 556
    • A'ali, Building 556, Bahrain
      • Recruiting
      • Abdulla Kanoo Center,
      • Contact: reem j ahmed; Phone Number: 0097333731313; Email: RAhmed4@health.gov.bh)
      • Contact: fatima alnashaba, md; Phone Number: 0097333779876

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: to be given as a treatment; Nitric Oxide Nasal Spray "Enovid"
Experimental: treatment arm; Nitric Oxide Nasal Spray "Enovid"	Drug: to be given as a treatment; Nitric Oxide Nasal Spray "Enovid"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of NONS compared to placebo in participants with COVID-19 to reduce mortality	To evaluate the efficacy of NONS compared to placebo to reduce mortality of participants with COVID-19	6 months
efficacy of NONS compared to placebo in participants with COVID-19 on viral load reduction	Viral load reduction measure in copies per ml in participants with mild COVID-19 infection.	6 months
efficacy of NONS compared to placebo in participants with COVID-19 to reduce time of clinical symptoms improvement	Median time reduction to COVID-19 clinical symptoms improvement in days	6 months
Incidence of Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Adverse Events to assess Safety and Tolerability]	6 months

Collaborators and Investigators

• Sponsor: Salmaniya Medical Complex

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVIDTX-CTP-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No