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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

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: NCT05012319
Recruitment Status : Recruiting
First Posted : August 19, 2021
Last Update Posted : August 19, 2021
Sponsor:
Information provided by (Responsible Party):
jameela al salman, Salmaniya Medical Complex

Study Description
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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).

Condition or disease Intervention/treatment Phase
Covid19 Drug: to be given as a treatment Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: the list of the members of the resrach team who will be blinided have been identiifed and a full procedure has been identified
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 5, 2021
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: treatment arm
Nitric Oxide Nasal Spray "Enovid"
 Drug: to be given as a treatment
Nitric Oxide Nasal Spray "Enovid"
Placebo Comparator: Placebo
Placebo
 Drug: to be given as a treatment
Nitric Oxide Nasal Spray "Enovid"


Outcome Measures
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Primary Outcome Measures :
  1. efficacy of NONS compared to placebo in participants with COVID-19 to reduce the need of urgent care [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. efficacy of NONS compared to placebo in participants with COVID-19 to reduce mortality [ Time Frame: 6 months ]
    To evaluate the efficacy of NONS compared to placebo to reduce mortality of participants with COVID-19

  2. efficacy of NONS compared to placebo in participants with COVID-19 on viral load reduction [ Time Frame: 6 months ]
    Viral load reduction measure in copies per ml in participants with mild COVID-19 infection.

  3. efficacy of NONS compared to placebo in participants with COVID-19 to reduce time of clinical symptoms improvement [ Time Frame: 6 months ]
    Median time reduction to COVID-19 clinical symptoms improvement in days

  4. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months ]
    Incidence of Treatment-Emergent Adverse Events to assess Safety and Tolerability]


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05012319


Contacts
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Contact: jameela m alsalman, MD 0097336515138 jsalman@health.gov.bh
Contact: Mariam alalawi, md 0097339960004 malalawi31@hotmail.com

Locations
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Bahrain
Abdulla Kanoo Center, Recruiting
A'ali, Building 556, Bahrain
Contact: reem j ahmed    0097333731313    RAhmed4@health.gov.bh)   
Contact: fatima alnashaba, md    0097333779876      
Sponsors and Collaborators
Salmaniya Medical Complex
More Information
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Responsible Party: jameela al salman, infectious disease consultant, Salmaniya Medical Complex
ClinicalTrials.gov Identifier: NCT05012319    
Other Study ID Numbers: COVIDTX-CTP-07
First Posted: August 19, 2021    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases