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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04312243|
Recruitment Status : Active, not recruiting
First Posted : March 18, 2020
Last Update Posted : November 10, 2022
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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)|
|Actual Enrollment :||24 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, 2023|
|Estimated Study Completion Date :||April 7, 2023|
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Age ≥18 years
- Scheduled to work with SARS-CoV-2 infected patients for at least 3 days in a week.
- Previous documented SARS-CoV-2 infections and subsequent negative SARS-CoV-2 rt-PCR test.
- Known hemoglobinopathies.
- Known anemia
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Lorenzo Berra, MD, Principal Investigator, Massachusetts General Hospital|
|Other Study ID Numbers:||
|First Posted:||March 18, 2020 Key Record Dates|
|Last Update Posted:||November 10, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
RNA Virus Infections
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Endothelium-Dependent Relaxing Factors