NO Prevention of COVID-19 for Healthcare Providers (NOpreventCOVID)
|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: NCT04312243|
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : June 16, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Infections Healthcare Associated Infection||Drug: Inhaled nitric oxide gas||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||470 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nitric Oxide Gas Inhalation for Prevention of COVID-19 in Healthcare Providers|
|Actual Study Start Date :||April 7, 2020|
|Estimated Primary Completion Date :||April 7, 2021|
|Estimated Study Completion Date :||April 7, 2022|
Experimental: Treatment Group
Inhaled NO (160 ppm) before and after the work shift. Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.
Drug: Inhaled nitric oxide gas
Control group: a SARS-CoV2 rt-PCR will be performed if symptoms arise. Treatment group: the subjects will breathe NO at the beginning of the shift and before leaving the hospital. Inspired NO will be delivered at 160 parts per million (ppm) for 15 minutes in each cycle. A SARS-CoV-2 rt-PCR will be performed if symptoms arise. Safety: Oxygenation and methemoglobin levels will be monitored via a non-invasive CO-oximeter. If methemoglobin levels rise above 5% at any point of the gas delivery, inhaled NO will be halvened. NO2 gas will be monitored and maintained below 5 ppm.
No Intervention: Control Group
Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.
- COVID-19 diagnosis [ Time Frame: 14 days ]Percentage of subjects with COVID-19 diagnosis in the two groups
- Positive SARS-CoV-2 rt-PCR test [ Time Frame: 14 days ]Percentage of subjects with a positive test in the two groups
- Total number of quarantine days [ Time Frame: 14 days ]Mean/ Median in the two groups
- Proportion of healthcare providers requiring quarantine [ Time Frame: 14 days ]Percentage in the two groups
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): NCT04312243
|Contact: Lorenzo Berra, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Lorenzo Berra email@example.com|