CClinicalTrials.gg
Status unknownNCT04355481ENVIROREAUpdated Apr 24, 2020

Dissemination of SARS-COV-2 (COVID-19) in the Environment of Infected Patients Admitted to Intensive Care Unit

An observational study in Covid-19 and Viral Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study summary

The objective of this protocol is to estimate the proportion of patients hospitalized in intensive care unit for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR. In fact, the hospital hygiene measures practiced in intensive care unit in patients with viral respiratory infection are identical to those practiced in other services. These measures are possibly insufficient as evidenced by recent data related to the COVID-19 epidemic.

Read the detailed description

Respiratory viruses are frequently responsible for acute respiratory failure which justifies hospitalization in intensive care unit. Actually, recent epidemics of emerging viruses (including COVID-19) have highlighted the possibility of air-type transmission in this specific population. Despite the fact that the risk of environmental contamination has never been objectified, It is probable that in intensive care patients, this contamination is greater than in other patients because of the gravity of the patients (greater inoculum) and the use of ventilation techniques responsible for probably increased exhaled viral expression. Defining the mode of transmission of respiratory viruses has major consequences in terms means of prevention. The "air" mode of transmission absolutely requires hospitalization in a single room and sometimes additional air treatment. The droplet transmission mode due to its short range requires simpler measures (wearing a surgical mask, no specific air treatment) and has also led to the discussion of the value of the individual room. Indeed, the use of high flow ventilation system such as "optiflow" or non-invasive ventilation, can transform a droplet risk into "air" risk. For this reason, measuring the extent of environmental contamination around infected patients in intensive care is a major issue.

02

Conditions studied

  • Covid-19
  • Viral Infection

Keywords

  • SARS-Cov-2
  • environmental contamination
  • intensive care unit
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 150 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients are recruited at the intensive care unit, for all patients admitted to intensive care for a low respiratory infection during which the SARS-Cov-2 virus (RT-PCR positive) is documented within 48 hours before carrying out the air and surfaces specimens.

Inclusion criteria

  • Patient over 18 years old.
  • Patient admitted to intensive care unit for a low respiratory infection during which the SARS-Cov-2 virus is documented, with a positive RT-PCR in the 48 hours before taking samples.
  • Information and not opposition from the patient / or family

Exclusion criteria

Exclusion Criteria:

  • No documentation of SARS-Cov-2 viral respiratory infection.
  • Patient under guardianship / curatorship
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Estimate the proportion of patients hospitalized in intensive care for a SARS-Cov-2 viral lung infection and contaminating their environment at 1 meter.

    The primary objective of the study will be evaluated by the proportion of patients contaminating the air 1 meter from their face. The contamination will be assessed by quantifying the viral RNA by RT-PCR on a 600-liter air sample aspirated by a Coriolis® system. This sample will be taken within 48 hours after the confirmation of SARS-Cov-2 infection, documented by RT-PCR.

    Time frame: within 48 hours of the confirmation of SARS-Cov-2 infection documented by RT-PCR

07

Study locations

1 of 3 sites recruiting
  • Service de réanimation Hôpital Avicenne
    Bobigny, 93000, France
    Recruiting
  • Service de réanimation Hôpital Bichat
    Paris, 75018, France
    Not yet recruiting
  • Service de réanimation Hôpital Tenon
    Paris, 75020, France
    • Guillaume Voiriot, Dr · Contact · 01 56 01 62 63
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04355481
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Apr 21, 2020
Start date
Apr 17, 2020
Primary completion
Oct 17, 2020 (estimated)
Completion
Dec 17, 2020 (estimated)
Last update
Apr 24, 2020

Study contacts

Yacine TANDJAOUI-LAMBIOTTE, Dr
Contact
yacine.tandjaoui-lambiotte@aphp.fr
06 64 17 19 36 ext. +33
Nacira DARGHAL
Contact
nacira.darghal@aphp.fr
0148957473 ext. +33
Yacine TANDJAOUI-LAMBIOTTE, Dr
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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