Covid19NCT04954235
Effectiveness and Safety Study of Specific Hyperimmune Equine Serum for the Treatment of Severe Hospitalized SARS-CoV-2 in Adults: Retrospective Cohort Study
An observational study of Covid19, run by Inmunova S.A. at 1 site in Argentina.
Trial summary
An observational, retrospective, classic cohort study of adult patients hospitalized for severe pneumonia with a diagnosis of SARS-CoV-2 by RT-PCR will be carried out. The cohort will be divided into two arms: a group of patients who received treatment with anti-SARS-CoV-2 hyperimmune serum and a group of patients not… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Covid19
- Type of treatment
- Injection or infusion
- How many people
- 847 participants
- Where
- 1 siteArgentina
- Study dates
- 22 May 2021to 9 Sep 2021
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients younger than 80 years hospitalized at the "Escuela Hogar" Hospital in Corrientes, Argentina, for severe pneumonia diagnosed with SARS-CoV-2
Who may be able to join
- Patients older than 18 years and younger than 80 years.
- Hospitalized for COVID-19 at the "Escuela Hogar" Hospital in Corrientes, Argentina from September 2020 to April 2021.
- Confirmed diagnosis of COVID-19 by SARS-CoV-2 Antigen Test or qualitative reverse transcriptase-polymerase chain reaction (qRT-PCR -GeneoDX Co, Ltd or similar) or Dosage of anti-SARS-CoV-2 IgG / IgM antibodies
- Who received hyperimmune anti-SARS-CoV-2 serum according to the indication approved by ANMAT for use after the approval date (January 2021 to April 2021) or Patients with the same indication corresponding to the period prior to the approval date (September 2020 to January 2020)
- With severe disease defined as individuals with tachypnea> 30 breaths per minute or oxygen saturation <94% ambient air or PaO2 / FiO2 <300, or pulmonary infiltrates> 50% on chest image.
Who cannot join
- Asymptomatic disease (individuals with a positive test for SARS-CoV-2, but who do not have symptoms), mild (individuals who have compatible symptoms, but without dyspnea and with a normal chest imaging study), moderate (individuals with evidence of lower respiratory tract disease on clinical or imaging evaluation, and oxygen saturation> = 94% room air) or critical (those with respiratory failure, septic shock, and / or multi-organ dysfunction).
- Patients who received anti-SARS-CoV-2 hyperimmune serum off-label approved by ANMAT for use according to Regulation 9175/20.
- Pregnant women.
- Lactating women.
- Patients who are on mechanical ventilation or admitted to the ICU at hospital admission.
- Confirmation of another concomitant microbiological cause of pneumonia other than COVID-19
Trial locations and contacts
1 site in 1 country.
About this study
An observational, retrospective, classic cohort study of adult patients hospitalized for severe pneumonia with a diagnosis of SARS-CoV-2 by RT-PCR will be carried out. The cohort will be divided into two arms: a group of patients who received treatment with anti-SARS-CoV-2 hyperimmune serum and a group of patients not exposed to the intervention during hospitalization corresponding to the period prior to the approval of the anti-hyperimmune serum SARS-CoV-2 for use. All patients will be have structured follow-up at 14, 21 and 28 days, until discharge or death.
Read the detailed description
A classic retrospective cohort observational study of adult patients hospitalized for severe pneumonia with a diagnosis of SARS-CoV-2 will be conducted. The date of admission to the cohort will be considered the date of admission. All patients will be followed with structured evaluations at 14, 21 and 28 days.
The cohort will be divided into two arms: a group of patients who received treatment with 2 infusions of 4 mg / Kg each of hyperimmune anti-SARS-CoV-2 serum (INM005, CoviFab®) separated by 48 hours, from the date of approval for its use; and a group of patients not exposed to said intervention during hospitalization corresponding to the period prior to the approval of the hyperimmune anti-SARS-CoV-2 serum for its use. CoviFab® has been authorized under special conditions by the Agency for Medicines, Food and Medical Technology (ANMAT) for the treatment of hospitalized patients with moderate to severe disease caused by the SARS-CoV-2 virus (Regulation 9175/20, 22 December 2020)
The study period that will be considered for the arm of patients exposed to anti-SARS-CoV-2 polyclonal hyperimmune serum is between January 27, 2021 and April 9, 2021. The study period to include patients not exposed to hyperimmune anti-SARS-CoV-2 serum is between September 1, 2020 to January 26, 2021. This last period was chosen because it is considered to be a time when there were no substantive differences in the diagnosis, categorization of risk, support measures or treatment of hospitalized adult patients with a confirmed diagnosis of COVID-19 pneumonia, and therefore corresponds to a valid period for comparison.
Although the "Escuela Hogar" Hospital began operating in July 2020, it was decided to exclude patients admitted for the first two months, considering that after two months of operation, the diagnostic, treatment and support systems are stable for the comparison between exposed and unexposed patients.
The study will be carried out in a collaborative manner between the Acute Campaign Hospital "Escuela Hogar" and the Hospital Italiano de Buenos Aires, which will act as the coordinating center for this study.
The Acute Campaign Hospital "Escuela Hogar" was designed and implemented to treat COVID-19 cases exclusively. It was inaugurated in July 2020 in the city of Corrientes, Argentine Republic, with the aim of functioning as a diagnostic and treatment center for patients affected by COVID-19 throughout the province of Corrientes[4].
It has a general hospitalization sector and a intensive care unit, with approximately 723 total beds available and 300 in the intensive care unit. The staff includes doctors, nurses and health personnel, as well as technicians and administrators trained in the care of patients affected by COVID-19. It has an Operations Center where the members of the Crisis Committee monitor the entire building and access in real time, the status of patients and the movement of that institution.
The hospital is paper free, and has a Computerized Medical Record. This data repository has additional information on patient admission, free text evolutions, structured indications, vital sign registration and support, and results of imaging studies reports such as X-rays and Tomography. The laboratory is in a different development that contains all the laboratories performed on each patient in each episode.
The data processing and analysis will be carried out in the area of the Research Department of the Hospital Italiano de Buenos Aires.
Variables Follow-up will be carried out with structured forms upon admission, days 14, 21 and 28. For the purposes of the study, we will include demographic variables (age, sex, BMI), presence of comorbidities (hypertension, diabetes, obesity, cancer, lung disease, liver disease, kidney disease, coronary / cardiovascular disease), the history of having received plasma in the previous 30 days or during hospitalization, the plasma dose, Charlson score; related to the patient's diagnosis and their baseline status at admission (diagnostic method , date of onset of symptoms, respiratory rate, oxygen saturation, PaO2 / FiO2, oxygen requirement, type of device indicated, NEWS score) and related to the evolution both in hospitalization and after hospital discharge until day 28 from hospital admission (need for supplemental oxygen, admission to mechanical ventilation, admission to ICU, clinical improvement, disease progression, death, discharge).
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed to Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F[ab']2 fragments | Group of patients with severe pneumonia who received treatment with 2 infusions of 4 mg / Kg each of hyperimmune anti-SARS-CoV-2 serum (INM005, CoviFab®) separated by 48 hours | |
| Not Exposed to Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F[ab']2 fragments | Group of patients with severe pneumonia not exposed to hyperimmune anti-SARS-CoV-2 serum (INM005, CoviFab®) during hospitalization corresponding to the period prior to the approval of the hyperimmune anti-SARS-CoV-2 serum for its use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at day 28
Proportion of patients who die at 28th day since hospital admission date
Measured: 28th day since hospital admission date
Secondary outcomes (10)
Mortality at days 14 and 21 after hospital admission.
Proportion of patients who die at 14th and 21st days since hospital admission date
Measured: 14th and 21st days since hospital admission date
Ordinal clinical scale at days 14, 21 and 28
Proportion of patients in each categorie at 14th, 21st and 28th days since hospital admission
Measured: 14th, 21st and 28th days since hospital admission date
Hospital discharge at days 14, 21 and 28.
Proportion of patients discharged from hospital on days 14, 21 and 28 since hospital admission date
Measured: 14th, 21st and 28th days since hospital admission date
Time to hospital discharge
Time to hospital discharge since hospital admission date (days).
Measured: Time to hospital discharge since hospital admission date in a 28 days follow up period
Patients admitted to Intensive Care Unit.
Proportion of patients admitted to Intensive Care Unit in a 28 days follow up period since hospital admission date
Measured: 28 days follow up period since hospital admission date
Time to discharge from the Intensive Care Unit
Time to discharge from the Intensive Care Unit since hospital admission date (days).
Measured: 28 days follow up period since hospital admission date
Days in Intensive Care Unit.
Total days hospitalized in Intensive Care Unit.
Measured: 28 days follow up period since hospital admission date
Patients on mechanical ventilation
Proportion of patients admitted to mechanical ventilation.
Measured: 28 days follow up period since hospital admission date
Time from the date of hospitalization to the start of mechanical ventilation.
Time to mechanical ventilation start since hospital admission date (days).
Measured: 28 days follow up period since hospital admission date
Adverse events / serious adverse events.
Proporcion of participants with adverse events / serious adverse events.
Measured: 28 days follow up period since hospital admission date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start22 May 2021
- Primary completion9 Sep 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 847 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmunova S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Italiano de Buenos Aires, Hospital de Campaña Escuela Hogar, Laboratorio Elea Phoenix S.A., Instituto de Virologia Dr. Jose Maria Vanella
- Responsible party
- Sponsor
- Investigators
- Mariana Colonna, Bioch, Principal investigator, Inmunova S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954235
- Sponsor's protocol ID
- 4484
- Status last verified
- Mar 2022
- First submitted
- 5 Jul 2021
- Last updated
- 6 Apr 2022
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Study of Specific Hyperimmune Equine Serum for the Treatment of Severe Hospitalized SARS-CoV-2 in Adults: Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04954235
- Acronym / sponsor ID
- 4484
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 847 participants (actual)
- Lead sponsor
- Inmunova S.A.University, hospital or other
- Collaborators
- Hospital Italiano de Buenos Aires, Hospital de Campaña Escuela Hogar, Laboratorio Elea Phoenix S.A., Instituto de Virologia Dr. Jose Maria Vanella
- Study start
- 22 May 2021 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 8 Jul 2021 (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.
An observational, retrospective, classic cohort study of adult patients hospitalized for severe pneumonia with a diagnosis of SARS-CoV-2 by RT-PCR will be carried out. The cohort will be divided into two arms: a group of patients who received treatment with anti-SARS-CoV-2 hyperimmune serum and a group of patients not exposed to the intervention during hospitalization corresponding to the period prior to the approval of the anti-hyperimmune serum SARS-CoV-2 for use. All patients will be have structured follow-up at 14, 21 and 28 days, until discharge or death.
Detailed description
A classic retrospective cohort observational study of adult patients hospitalized for severe pneumonia with a diagnosis of SARS-CoV-2 will be conducted. The date of admission to the cohort will be considered the date of admission. All patients will be followed with structured evaluations at 14, 21 and 28 days.
The cohort will be divided into two arms: a group of patients who received treatment with 2 infusions of 4 mg / Kg each of hyperimmune anti-SARS-CoV-2 serum (INM005, CoviFab®) separated by 48 hours, from the date of approval for its use; and a group of patients not exposed to said intervention during hospitalization corresponding to the period prior to the approval of the hyperimmune anti-SARS-CoV-2 serum for its use. CoviFab® has been authorized under special conditions by the Agency for Medicines, Food and Medical Technology (ANMAT) for the treatment of hospitalized patients with moderate to severe disease caused by the SARS-CoV-2 virus (Regulation 9175/20, 22 December 2020)
The study period that will be considered for the arm of patients exposed to anti-SARS-CoV-2 polyclonal hyperimmune serum is between January 27, 2021 and April 9, 2021. The study period to include patients not exposed to hyperimmune anti-SARS-CoV-2 serum is between September 1, 2020 to January 26, 2021. This last period was chosen because it is considered to be a time when there were no substantive differences in the diagnosis, categorization of risk, support measures or treatment of hospitalized adult patients with a confirmed diagnosis of COVID-19 pneumonia, and therefore corresponds to a valid period for comparison.
Although the "Escuela Hogar" Hospital began operating in July 2020, it was decided to exclude patients admitted for the first two months, considering that after two months of operation, the diagnostic, treatment and support systems are stable for the comparison between exposed and unexposed patients.
The study will be carried out in a collaborative manner between the Acute Campaign Hospital "Escuela Hogar" and the Hospital Italiano de Buenos Aires, which will act as the coordinating center for this study.
The Acute Campaign Hospital "Escuela Hogar" was designed and implemented to treat COVID-19 cases exclusively. It was inaugurated in July 2020 in the city of Corrientes, Argentine Republic, with the aim of functioning as a diagnostic and treatment center for patients affected by COVID-19 throughout the province of Corrientes[4].
It has a general hospitalization sector and a intensive care unit, with approximately 723 total beds available and 300 in the intensive care unit. The staff includes doctors, nurses and health personnel, as well as technicians and administrators trained in the care of patients affected by COVID-19. It has an Operations Center where the members of the Crisis Committee monitor the entire building and access in real time, the status of patients and the movement of that institution.
The hospital is paper free, and has a Computerized Medical Record. This data repository has additional information on patient admission, free text evolutions, structured indications, vital sign registration and support, and results of imaging studies reports such as X-rays and Tomography. The laboratory is in a different development that contains all the laboratories performed on each patient in each episode.
The data processing and analysis will be carried out in the area of the Research Department of the Hospital Italiano de Buenos Aires.
Variables Follow-up will be carried out with structured forms upon admission, days 14, 21 and 28. For the purposes of the study, we will include demographic variables (age, sex, BMI), presence of comorbidities (hypertension, diabetes, obesity, cancer, lung disease, liver disease, kidney disease, coronary / cardiovascular disease), the history of having received plasma in the previous 30 days or during hospitalization, the plasma dose, Charlson score; related to the patient's diagnosis and their baseline status at admission (diagnostic method , date of onset of symptoms, respiratory rate, oxygen saturation, PaO2 / FiO2, oxygen requirement, type of device indicated, NEWS score) and related to the evolution both in hospitalization and after hospital discharge until day 28 from hospital admission (need for supplemental oxygen, admission to mechanical ventilation, admission to ICU, clinical improvement, disease progression, death, discharge).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed to Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F[ab']2 fragments | – | –Group of patients with severe pneumonia who received treatment with 2 infusions of 4 mg / Kg each of hyperimmune anti-SARS-CoV-2 serum (INM005, CoviFab®) separated by 48 hours |
| Not Exposed to Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F[ab']2 fragments | – | –Group of patients with severe pneumonia not exposed to hyperimmune anti-SARS-CoV-2 serum (INM005, CoviFab®) during hospitalization corresponding to the period prior to the approval of the hyperimmune anti-SARS-CoV-2 serum for its use. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients younger than 80 years hospitalized at the "Escuela Hogar" Hospital in Corrientes, Argentina, for severe pneumonia diagnosed with SARS-CoV-2
Key inclusion criteria (5 listed)
- Patients older than 18 years and younger than 80 years.
- Hospitalized for COVID-19 at the "Escuela Hogar" Hospital in Corrientes, Argentina from September 2020 to April 2021.
- Confirmed diagnosis of COVID-19 by SARS-CoV-2 Antigen Test or qualitative reverse transcriptase-polymerase chain reaction (qRT-PCR -GeneoDX Co, Ltd or similar) or Dosage of anti-SARS-CoV-2 IgG / IgM antibodies
- Who received hyperimmune anti-SARS-CoV-2 serum according to the indication approved by ANMAT for use after the approval date (January 2021 to April 2021) or Patients with the same indication corresponding to the period prior to the approval date (September 2020 to January 2020)
- With severe disease defined as individuals with tachypnea> 30 breaths per minute or oxygen saturation <94% ambient air or PaO2 / FiO2 <300, or pulmonary infiltrates> 50% on chest image.
Key exclusion criteria (6 listed)
- Asymptomatic disease (individuals with a positive test for SARS-CoV-2, but who do not have symptoms), mild (individuals who have compatible symptoms, but without dyspnea and with a normal chest imaging study), moderate (individuals with evidence of lower respiratory tract disease on clinical or imaging evaluation, and oxygen saturation> = 94% room air) or critical (those with respiratory failure, septic shock, and / or multi-organ dysfunction).
- Patients who received anti-SARS-CoV-2 hyperimmune serum off-label approved by ANMAT for use according to Regulation 9175/20.
- Pregnant women.
- Lactating women.
- Patients who are on mechanical ventilation or admitted to the ICU at hospital admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality at day 28
Time frame: 28th day since hospital admission date
Proportion of patients who die at 28th day since hospital admission date
10 secondary outcomes
Mortality at days 14 and 21 after hospital admission.
Time frame: 14th and 21st days since hospital admission date
Ordinal clinical scale at days 14, 21 and 28
Time frame: 14th, 21st and 28th days since hospital admission date
Hospital discharge at days 14, 21 and 28.
Time frame: 14th, 21st and 28th days since hospital admission date
Time to hospital discharge
Time frame: Time to hospital discharge since hospital admission date in a 28 days follow up period
Patients admitted to Intensive Care Unit.
Time frame: 28 days follow up period since hospital admission date
Time to discharge from the Intensive Care Unit
Time frame: 28 days follow up period since hospital admission date
Days in Intensive Care Unit.
Time frame: 28 days follow up period since hospital admission date
Patients on mechanical ventilation
Time frame: 28 days follow up period since hospital admission date
Time from the date of hospitalization to the start of mechanical ventilation.
Time frame: 28 days follow up period since hospital admission date
Adverse events / serious adverse events.
Time frame: 28 days follow up period since hospital admission date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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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.
Mariana Colonna, Bioch principal investigator
Inmunova S.A.
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 Covid19, run by Inmunova S.A. at 1 site in Argentina.
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 6 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: finished, as of the sponsor's last update on 6 Apr 2022. 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at day 28 (time frame: 28th day since hospital admission date). 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 6 Apr 2022.