Covid19Phase 3NCT05012319
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 Phase 3 study testing to be given as a treatment in people with Covid19, run by Salmaniya Medical Complex at 1 site in Bahrain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- to be given as a treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteBahrain
- Study dates
- 5 Aug 2021to 30 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Bahrain1 site, 1 recruiting
- Recruiting
Abdulla Kanoo Center,
A'ali, Building 556
reem j ahmed, 0097333731313, RAhmed4@health.gov.bh)
fatima alnashaba, md, 0097333779876
About this study
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
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).
Read the 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
- Being tested
- to be given as a treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to be given as a treatmentDrug
Nitric Oxide Nasal Spray "Enovid"
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Nitric Oxide Nasal Spray "Enovid" Receives: Drug: to be given as a treatment |
| Placebo | Placebo comparator | Placebo Receives: Drug: to be given as a treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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
Measured: 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.
Measured: 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
Measured: 6 months
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events to assess Safety and Tolerability]
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start5 Aug 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salmaniya Medical Complex
- Sponsor type
- Other government
- Responsible party
- Principal investigator, jameela al salman, Salmaniya Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012319
- Sponsor's protocol ID
- COVIDTX-CTP-07
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05012319
- Acronym / sponsor ID
- COVIDTX-CTP-07
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Salmaniya Medical ComplexOther government
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: to be given as a treatmentNitric Oxide Nasal Spray "Enovid" |
| Placebo | Placebo comparator | Drug: to be given as a treatmentPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- Asymptomatic participants must be high risk defined as (any of the following):
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| to be given as a treatmentNitric Oxide Nasal Spray "Enovid" | Drug | Placebo, treatment arm |
Primary outcome
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.
4 secondary outcomes
efficacy of NONS compared to placebo in participants with COVID-19 to reduce mortality
Time frame: 6 months
efficacy of NONS compared to placebo in participants with COVID-19 on viral load reduction
Time frame: 6 months
efficacy of NONS compared to placebo in participants with COVID-19 to reduce time of clinical symptoms improvement
Time frame: 6 months
Incidence of Treatment-Emergent Adverse Events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing to be given as a treatment in people with Covid19, run by Salmaniya Medical Complex at 1 site in Bahrain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jameela m alsalman, MD (0097336515138, jsalman@health.gov.bh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of NONS compared to placebo in participants with COVID-19 to reduce the need of urgent care (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.