NCT04312243

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

April 7, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

March 20, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 15, 2020

Results QC Date

February 10, 2026

Last Update Submit

March 18, 2026

Conditions

Coronavirus InfectionsHealthcare Associated Infection

Outcome Measures

Primary Outcomes (1)

  • COVID-19 Diagnosis

    Percentage of subjects with COVID-19 diagnosis in the two groups

    14 days

Secondary Outcomes (1)

  • Positive SARS-CoV-2 Rt-PCR Test

    14 days

Other Outcomes (2)

  • Total Number of Quarantine Days

    14 days

  • Proportion of Healthcare Providers Requiring Quarantine

    14 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

NO INTERVENTION

Daily monitoring of body temperature and symptoms. SARS-CoV-2 RT-PCR test if fever or COVID-19 symptoms.

Interventions

Inhaled nitric oxide gasDRUG

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.

Treatment Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Scheduled to work with SARS-CoV-2 infected patients for at least 3 days in a week.

You may not qualify if:

  • Previous documented SARS-CoV-2 infections and subsequent negative SARS-CoV-2 rt-PCR test.
  • Pregnancy
  • Known hemoglobinopathies.
  • Known anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • Akerstrom 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.

    PMID: 19800091BACKGROUND

  • 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. doi: 10.1016/j.ijid.2004.04.012.

    PMID: 15234326BACKGROUND

  • Akhtar S, Das JK, Ismail T, Wahid M, Saeed W, Bhutta ZA. Nutritional perspectives for the prevention and mitigation of COVID-19. Nutr Rev. 2021 Feb 11;79(3):289-300. doi: 10.1093/nutrit/nuaa063.

    PMID: 33570583DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsCross Infection

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Lorenzo Berra, MD
Organization
Massachusetts General Hospital
lberra@mgh.harvard.edu
617-726-3030

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2020

First Posted

March 18, 2020

Study Start

April 7, 2020

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

March 20, 2026

Results First Posted

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)