Coronavirus Infections Clinical Trial
— NOpreventCOVIDOfficial title:
Nitric Oxide Gas Inhalation for Prevention of COVID-19 in Healthcare Providers
Verified date | November 2022 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Thousands of healthcare workers have been infected with SARS-CoV-2 and contracted COVID-19 despite their best efforts to prevent contamination. No proven vaccine is available to protect healthcare workers against SARS-CoV-2. This study will enroll 470 healthcare professionals dedicated to care for patients with proven SARS-CoV-2 infection. Subjects will be randomized either in the observational (control) group or in the inhaled nitric oxide group. All personnel will observe measures on strict precaution in accordance with WHO and the CDC regulations.
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | April 7, 2023 |
Est. primary completion date | April 7, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Age =18 years 2. Scheduled to work with SARS-CoV-2 infected patients for at least 3 days in a week. Exclusion Criteria: 1. Previous documented SARS-CoV-2 infections and subsequent negative SARS-CoV-2 rt-PCR test. 2. Pregnancy 3. Known hemoglobinopathies. 4. Known anemia |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Akerström S, Gunalan V, Keng CT, Tan YJ, Mirazimi A. Dual effect of nitric oxide on SARS-CoV replication: viral RNA production and palmitoylation of the S protein are affected. Virology. 2009 Dec 5;395(1):1-9. doi: 10.1016/j.virol.2009.09.007. Epub 2009 Oct 1. — View Citation
Keyaerts E, Vijgen L, Chen L, Maes P, Hedenstierna G, Van Ranst M. Inhibition of SARS-coronavirus infection in vitro by S-nitroso-N-acetylpenicillamine, a nitric oxide donor compound. Int J Infect Dis. 2004 Jul;8(4):223-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Total number of quarantine days | Mean/ Median in the two groups | 14 days | |
Other | Proportion of healthcare providers requiring quarantine | Percentage in the two groups | 14 days | |
Primary | COVID-19 diagnosis | Percentage of subjects with COVID-19 diagnosis in the two groups | 14 days | |
Secondary | Positive SARS-CoV-2 rt-PCR test | Percentage of subjects with a positive test in the two groups | 14 days |
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