Sars-CoV2Phase 2GERONIMO 19NCT04403269
NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER, COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE
A Phase 2 study testing IgIV in people with Sars-CoV2, run by Versailles Hospital at 1 site in France.
Trial summary
According to recent data, death rate is more than 20% for 75 years old hospitalized patients and older. In case of aggravation, according to the latest observations, if they are refused for mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- IgIV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2020to 5 May 2021
- Phase
- Phase 2
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Man or woman aged 75 and over
- SARS-coV2 infection confirmed by RT-PCR or thoraco-pulmonary CT
- Hospitalized in the acute general geriatrics unit of the Versailles Hospital Center
- Patient rejected from resuscitation
- Saturation ≤ 95% under oxygen therapy> 5 L / min (i.e. PaO2 / FiO2≤200mmHg according to the Berlin definition of ARDS) by means of a nasal cannula, a high concentration facial mask or another device similar oxygen distribution
Who cannot join
- Patient under palliative care
- Patient with contraindication to IV polyvalent Ig
- . Hypersensitivity to the active substance or to any of the excipients (L-proline)
- . Hypersensitivity to human immunoglobulins, especially when the patient has anti-IgA antibodies,
- . Patients with type I or II hyperprolinemia
- Patient under guardianship or curatorship
Show all 10Show fewer
- Patient receiving another experimental treatment as part of an interventional study
- Moderate to severe dementia known: it must have been diagnosed before hospitalization and is defined by an MMSE <20/30 or a neuropsychological assessment with a diagnosis made.
- Patient not affiliated with a social security system in France
- ADL patients <4/6 and / or IADL <6/8
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Versailles
Le Chesnay, 78150
Laure PARNET
About this study
Official title: "STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE" GERONIMO 19
According to recent data, death rate is more than 20% for 75 years old hospitalized patients and older.
In case of aggravation, according to the latest observations, if they are refused for mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity.
Read more
Apart from an increase in oxygen therapy, no specific treatment is currently proposed.
The control of the inflammatory component seems to be a key element to be able to influence the patients' health evolution.
Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties with a favorable safety profile for these elderly patients and several clinical cases lead to positive impact in the caring for Covid patients.
This study objective is evaluation of the efficacy of polyvalent IVIg in combination with the standard management of patients aged 75 and over with SARSCov2 infection with acute respiratory failure (saturation ≤ 95%) requiring oxygen therapy> 5 L / min (i.e. patients considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200) and disqualified from a care in the ICU.
- Conditions
- Sars-CoV2
- Being tested
- IgIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgIVDrug
2 infusion at D1 and D2 (0.8 g / kg by IV infusion)
| Study group | Role | What they receive |
|---|---|---|
| IgIV | Experimental | The experimental arm is human immunoglobulins. 2 infusion at D1 and D2. (0.8 g / kg by IV infusion) Receives: Drug: IgIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Day 14
Secondary outcomes (14)
Total number of days of full hospitalization
Measured: 3 and 6 months
Duration of oxygen therapy
Measured: 3 and 6 months
Ferritin level in the blood
Measured: 3 and 6 months
CRP level in the blood
Measured: 3 and 6 months
LDH level in the blood
Measured: 3 and 6 months
Lymphocyte level in the blood
Measured: 3 and 6 months
PNN level in the blood
Measured: 3 and 6 months
platelet level in the blood
Measured: 3 and 6 months
WHO performance index
Measured: 3 and 6 months
WHOQOL-OLD questionnaire
Measured: 3 and 6 months
Lung function by pulmonary computed tomography
Measured: 3 and 6 months
Lung function by EFR
Measured: 3 and 6 months
Mortality
Measured: 3 and 6 months
Readmission Rates
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start5 May 2020
- Primary completion5 May 2021 (estimated)
- Study completion5 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Laure PARNET, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403269
- Sponsor's protocol ID
- P20/07 GERONIMO 19
- Acronym
- GERONIMO 19
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE" GERONIMO 19
- ClinicalTrials.gov ID
- NCT04403269
- Acronym / sponsor ID
- GERONIMO 19 / P20/07 GERONIMO 19
- Conditions
- Sars-CoV2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 5 May 2021 (estimated)
- Study completion
- 5 May 2021 (estimated)
- First posted
- 27 May 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.
According to recent data, death rate is more than 20% for 75 years old hospitalized patients and older.
In case of aggravation, according to the latest observations, if they are refused for mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity.
Apart from an increase in oxygen therapy, no specific treatment is currently proposed.
The control of the inflammatory component seems to be a key element to be able to influence the patients' health evolution.
Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties with a favorable safety profile for these elderly patients and several clinical cases lead to positive impact in the caring for Covid patients.
This study objective is evaluation of the efficacy of polyvalent IVIg in combination with the standard management of patients aged 75 and over with SARSCov2 infection with acute respiratory failure (saturation ≤ 95%) requiring oxygen therapy> 5 L / min (i.e. patients considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200) and disqualified from a care in the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IgIV | Experimental | Drug: IgIVThe experimental arm is human immunoglobulins. 2 infusion at D1 and D2. (0.8 g / kg by IV infusion) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Man or woman aged 75 and over
- SARS-coV2 infection confirmed by RT-PCR or thoraco-pulmonary CT
- Hospitalized in the acute general geriatrics unit of the Versailles Hospital Center
- Patient rejected from resuscitation
- Saturation ≤ 95% under oxygen therapy> 5 L / min (i.e. PaO2 / FiO2≤200mmHg according to the Berlin definition of ARDS) by means of a nasal cannula, a high concentration facial mask or another device similar oxygen distribution
Key exclusion criteria (10 listed)
- Patient under palliative care
- Patient with contraindication to IV polyvalent Ig
- Patient under guardianship or curatorship
- Patient receiving another experimental treatment as part of an interventional study
- Moderate to severe dementia known: it must have been diagnosed before hospitalization and is defined by an MMSE <20/30 or a neuropsychological assessment with a diagnosis made.
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 |
|---|---|---|
| IgIV2 infusion at D1 and D2 (0.8 g / kg by IV infusion) | Drug | IgIV |
Primary outcome
Mortality
Time frame: Day 14
14 secondary outcomes
Total number of days of full hospitalization
Time frame: 3 and 6 months
Duration of oxygen therapy
Time frame: 3 and 6 months
Ferritin level in the blood
Time frame: 3 and 6 months
CRP level in the blood
Time frame: 3 and 6 months
LDH level in the blood
Time frame: 3 and 6 months
Lymphocyte level in the blood
Time frame: 3 and 6 months
PNN level in the blood
Time frame: 3 and 6 months
platelet level in the blood
Time frame: 3 and 6 months
WHO performance index
Time frame: 3 and 6 months
WHOQOL-OLD questionnaire
Time frame: 3 and 6 months
Lung function by pulmonary computed tomography
Time frame: 3 and 6 months
Lung function by EFR
Time frame: 3 and 6 months
Mortality
Time frame: 3 and 6 months
Readmission Rates
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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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?
A Phase 2 study testing IgIV in people with Sars-CoV2, run by Versailles Hospital at 1 site in France.
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 5 inclusion and 10 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 27 May 2020. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mélody FORT (+33139239776, mfort@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Day 14). 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 27 May 2020.