A Phase 3 interventional study of to be given as a treatment in Covid19, sponsored by Salmaniya Medical Complex. Status unknown at 1 site in Bahrain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-19.
Sponsored by Salmaniya Medical Complex · Phase 3, Interventional, and Treatment
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 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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 500 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Salmaniya Medical Complex is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Mild COVID-19 Infection defined as:
Asymptomatic participants must be high risk defined as (any of the following):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nitric Oxide Nasal Spray "Enovid"
Drug: to be given as a treatment
Placebo
Drug: to be given as a treatment
Nitric Oxide Nasal Spray "Enovid"
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.
Time frame: 6 months
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
Time frame: 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.
Time frame: 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
Time frame: 6 months
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events to assess Safety and Tolerability\]
Time frame: 6 months
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Salmaniya Medical Complex