COVID 19NCT04438863
Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19
An observational study of COVID 19, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of this preliminary study is to describe the potential decline in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in high-risk subjects infected with COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COVID 19
- What is being tested?
- home spirometry
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Aug 2020to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: confirmed COVID19 patients (hospitalized or not hospitalized) with mild to moderate symptoms. (low grade fever, cough, anosmia, fatigue, discomfort, anorexia or other gastrointestinal symptoms)
Who may be able to join
- without dyspnea and with no evidence of pneumonia, ARDS, organ failure or requiring admission to ICU.
- All patients ≥55 years age or ≥1 risk factor for disease complications (prior pulmonary, kidney or cardiovascular disease, diabetes mellitus, hypertension, bone merrow suppression, solid organ transplant, HIV with CD4<250, heavy smoker, BMI >30). All participants will sign a written informed consent.
Who cannot join
- Patients unable to perform spirometry
- contraindications for spirometry (hemoptysis, active tuberculosis, syncope associated with forced exhalation or increased risk for spirometry)
- adhere to the follow-up protocol.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Gal Varshavsky, 972-3-5305997, Gal.Varshavsky@sheba.health.gov.il
About this study
Official title: A Descriptive Pilot Study of Daily Home Spirometry for Early Detection of Pulmonary Complications in High Risk Patients With COVID19
The aim of this preliminary study is to describe the potential decline in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in high-risk subjects infected with COVID-19. We hypothesize that the magnitude of such a decline in FEV1 and/or FVC may be associated with clinical deterioration and hospitalization. The study will ultimately inform a larger subsequent RCT that will evaluate the efficacy of home spirometry in the early detection (pre respiratory symptoms) of respiratory complications and therefore prompt early medical attention which is a key for improving outcome.
- Conditions
- COVID 19
- Being tested
- home spirometry
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home spirometryDiagnostic test
portable hand-held spirometer to collect and store daily spirometric data (including FVC, FEV1, forced expiratory flow after 25 to 75% of vital capacity has been expelled, and peak flow).
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization
participants that are hospitalized
Measured: number of participants hospitalized in a time frame of a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start8 Aug 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Liran Levy, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438863
- Sponsor's protocol ID
- SHEBA-20-7022-SMC-LL-CTIL
- Status last verified
- Nov 2021
- First submitted
- 17 Jun 2020
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Pilot Study of Daily Home Spirometry for Early Detection of Pulmonary Complications in High Risk Patients With COVID19
- ClinicalTrials.gov ID
- NCT04438863
- Acronym / sponsor ID
- SHEBA-20-7022-SMC-LL-CTIL
- Conditions
- COVID 19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this preliminary study is to describe the potential decline in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in high-risk subjects infected with COVID-19. We hypothesize that the magnitude of such a decline in FEV1 and/or FVC may be associated with clinical deterioration and hospitalization. The study will ultimately inform a larger subsequent RCT that will evaluate the efficacy of home spirometry in the early detection (pre respiratory symptoms) of respiratory complications and therefore prompt early medical attention which is a key for improving outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- confirmed COVID19 patients (hospitalized or not hospitalized) with mild to moderate symptoms. (low grade fever, cough, anosmia, fatigue, discomfort, anorexia or other gastrointestinal symptoms)
Key inclusion criteria (2 listed)
- without dyspnea and with no evidence of pneumonia, ARDS, organ failure or requiring admission to ICU.
- All patients ≥55 years age or ≥1 risk factor for disease complications (prior pulmonary, kidney or cardiovascular disease, diabetes mellitus, hypertension, bone merrow suppression, solid organ transplant, HIV with CD4<250, heavy smoker, BMI >30). All participants will sign a written informed consent.
Key exclusion criteria (3 listed)
- Patients unable to perform spirometry
- contraindications for spirometry (hemoptysis, active tuberculosis, syncope associated with forced exhalation or increased risk for spirometry)
- adhere to the follow-up protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home spirometryportable hand-held spirometer to collect and store daily spirometric data (including FVC, FEV1, forced expiratory flow after 25 to 75% of vital capacity has been expelled, and peak flow). | Diagnostic test | – |
Primary outcome
Hospitalization
Time frame: number of participants hospitalized in a time frame of a year
participants that are hospitalized
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID 19, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gal Varshavsky (972-3-5305997, Gal.Varshavsky@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization (time frame: number of participants hospitalized in a time frame of a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.