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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
Sponsor:
Information provided by (Responsible Party):
Lorenzo Berra, MD, Massachusetts General Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. COVID-19 diagnosis [ Time Frame: 14 days ]
    Percentage of subjects with COVID-19 diagnosis in the two groups


Secondary Outcome Measures :
  1. Positive SARS-CoV-2 rt-PCR test [ Time Frame: 14 days ]
    Percentage of subjects with a positive test in the two groups


Other Outcome Measures:
  1. Total number of quarantine days [ Time Frame: 14 days ]
    Mean/ Median in the two groups

  2. Proportion of healthcare providers requiring quarantine [ Time Frame: 14 days ]
    Percentage in the two groups



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Lorenzo Berra, MD +16176437733 lberra@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lorenzo Berra       lberra@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Publications:
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Responsible Party: Lorenzo Berra, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04312243    
Other Study ID Numbers: NOpreCOVID-19
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Nitric Oxide
Infection
Communicable Diseases
Cross Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents