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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | Nitric Oxide Nasal Spray "Enovid" |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| to be given as a treatment | Drug | Nitric Oxide Nasal Spray "Enovid" |
|
| 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 |
| 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 |
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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:
Asymptomatic participants must be high risk defined as (any of the following):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jameela m alsalman, MD | Contact | 0097336515138 | jsalman@health.gov.bh | |
| Mariam alalawi, md | Contact | 0097339960004 | malalawi31@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abdulla Kanoo Center, | Recruiting | A'ali | Building 556 | Bahrain |
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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.
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the list of the members of the resrach team who will be blinided have been identiifed and a full procedure has been identified
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 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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