COVID-19 InfectionSAM-COVIDNCT04382781
Immunosupressive Treatment in COVID-19 Patients
An observational study of COVID-19 Infection, run by Spanish Network for Research in Infectious Diseases at 1 site in Spain.
Trial summary
SAM-COVID is a retrospective cohort study that aims to determine the impact of immunosuppressive drugs and immunoglubulins in the outcome of patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- NO-Immunosuppressive, Immunosuppressive and Immunoglubulins
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- May 2020to May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients admitted to Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who showed clinical and analytical data suggestive of macrophage activation syndrome during admission until March 30, 2020 .
Who may be able to join
- Adult patients (≥18 years) admitted because of COVID-19 confirmed by PCR in nasopharyngeal swab or lower respiratory tract sample and presenting on a specific date (day 0) one clinical and one laboratory criteria of the following:
- Clinical criteria:
- Temperature ≥38ºC.
- Worsening in oxygen requirements to achieve O2 saturation >92%.
- Laboratory criteria:
- Ferritin >2000 ng/mL or increment in >1000 ng/ML since admission.
- D-dimer >1500 µg/mL (or duplicate in 24h)
- IL6 >50 pg/mL.
Who cannot join
- Mechanical ventilation in day 0.
- Decision of provide only palliative care before day 0.
- Use of systemic steroids, tocilizumab, other immunosupressors, or immunoglobulins before day 0.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Virgen Macarena
Seville, 41071
Jesús Rodriguez-Baño, MD, PhD
About this study
Official title: Effect of Immunosupressive Treatment in COVID-19 Patients Whit SAM-LIKE Profile: Retrospective Cohort Study (SAM-COVID Project)
SAM-COVID is a retrospective cohort study that aims to determine the impact of immunosuppressive drugs and immunoglubulins in the outcome of patients with COVID-19.
Read the detailed description
SAM-COVID is a retrospective cohort study of patients admitted to 66 Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presenting during admission with clinical and laboratory data suggestive of macrophage activation syndrome with the objective to investigate whether the use of immunosuppressive drugs (including high-dose steroids, tocilizumab, sarilumab, anakimra) or immunoglobulins in avoiding the need for invasive mechanical ventilation or in-hospital death.
The Ethics Committee for Research of Virgen Macarena and Virgen del Rocío University Hospitals approved the study and waived the need to obtain informed consent.
The data source was the electronic medical records. All data were entered directly by personnel at each institution using an online case report form (CRF), that satisfied local requirements of data confidentiality.
The variables registered included administrative data, epidemiological information, type of clinical specimen in which the diagnosis was confirmed, demographics, comorbidities and current medications, signs and symptoms at admission, baseline laboratory tests results and at day 0, chest X-ray findings at baseline and during follow-up, medications with potential activity against COVID-19, supportive treatments including oxygen therapy, use of immunosuppressant medications or immunoglobulins, and outcome.
- Conditions
- COVID-19 Infection
- Being tested
- NO-Immunosuppressive, Immunosuppressive, Immunoglubulins
- Keywords
- COVID-19, SARS-CoV-2, Immunosuppressive, Immunoglubulins
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO-ImmunosuppressiveDrug
Patients not receiving immunosuppressive drugs
ImmunosuppressiveDrug
Patients receiving immunosuppressive drugs (overall, and specific drugs)
ImmunoglubulinsDrug
Patients receiving immunoglubulins
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 infection | Consecutive patients admitted to Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who showed clinical and analytical data suggestive of macrophage activation syndrome during admission until March 30, 2020 . Receives: Drug: NO-Immunosuppressive; Drug: Immunosuppressive; Drug: Immunoglubulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive ventilation or death
Days until invasive mechanical ventilation or death, whatever happened first.
Measured: Up to 21 days
Secondary outcomes (5)
Ventilation
Days until mechanical ventilation
Measured: Up to 21 days
Death
Days until death
Measured: Up to 21 days
Secondary infections
Proportion of patients developing secondary infections
Measured: Up to 21 days
Digestive tract hemorrhage
Proportion of patients with digestive tract hemorrhage
Measured: Up to 21 days
Change in 7 points scale
Proportion of patients with imnprovement in 2 or more points in 7-point scale by WHO
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study startMay 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Network for Research in Infectious Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Responsible party
- Principal investigator, JESUS RODRIGUEZ BAÑO, Spanish Network for Research in Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382781
- Sponsor's protocol ID
- FIS-INM-2020-03
- Acronym
- SAM-COVID
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immunosupressive Treatment in COVID-19 Patients Whit SAM-LIKE Profile: Retrospective Cohort Study (SAM-COVID Project)
- ClinicalTrials.gov ID
- NCT04382781
- Acronym / sponsor ID
- SAM-COVID / FIS-INM-2020-03
- Conditions
- COVID-19 Infection
- Keywords
- COVID-19, SARS-CoV-2, Immunosuppressive, Immunoglubulins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Spanish Network for Research in Infectious DiseasesUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Study start
- May 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 11 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.
SAM-COVID is a retrospective cohort study that aims to determine the impact of immunosuppressive drugs and immunoglubulins in the outcome of patients with COVID-19.
Detailed description
SAM-COVID is a retrospective cohort study of patients admitted to 66 Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presenting during admission with clinical and laboratory data suggestive of macrophage activation syndrome with the objective to investigate whether the use of immunosuppressive drugs (including high-dose steroids, tocilizumab, sarilumab, anakimra) or immunoglobulins in avoiding the need for invasive mechanical ventilation or in-hospital death.
The Ethics Committee for Research of Virgen Macarena and Virgen del Rocío University Hospitals approved the study and waived the need to obtain informed consent.
The data source was the electronic medical records. All data were entered directly by personnel at each institution using an online case report form (CRF), that satisfied local requirements of data confidentiality.
The variables registered included administrative data, epidemiological information, type of clinical specimen in which the diagnosis was confirmed, demographics, comorbidities and current medications, signs and symptoms at admission, baseline laboratory tests results and at day 0, chest X-ray findings at baseline and during follow-up, medications with potential activity against COVID-19, supportive treatments including oxygen therapy, use of immunosuppressant medications or immunoglobulins, and outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 infection | – | Drug: NO-Immunosuppressive, Drug: Immunosuppressive, Drug: ImmunoglubulinsConsecutive patients admitted to Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who showed clinical and analytical data suggestive of macrophage activation syndrome during admission until March 30, 2020 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted to Spanish hospitals with laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction (RT-PCR) assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who showed clinical and analytical data suggestive of macrophage activation syndrome during admission until March 30, 2020 .
Key inclusion criteria (8 listed)
- Adult patients (≥18 years) admitted because of COVID-19 confirmed by PCR in nasopharyngeal swab or lower respiratory tract sample and presenting on a specific date (day 0) one clinical and one laboratory criteria of the following:
- Temperature ≥38ºC.
- Worsening in oxygen requirements to achieve O2 saturation >92%.
- Ferritin >2000 ng/mL or increment in >1000 ng/ML since admission.
- D-dimer >1500 µg/mL (or duplicate in 24h)
Key exclusion criteria (3 listed)
- Mechanical ventilation in day 0.
- Decision of provide only palliative care before day 0.
- Use of systemic steroids, tocilizumab, other immunosupressors, or immunoglobulins before day 0.
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 |
|---|---|---|
| NO-ImmunosuppressivePatients not receiving immunosuppressive drugs | Drug | COVID-19 infection |
| ImmunosuppressivePatients receiving immunosuppressive drugs (overall, and specific drugs) | Drug | COVID-19 infection |
| ImmunoglubulinsPatients receiving immunoglubulins | Drug | COVID-19 infection |
Primary outcome
Invasive ventilation or death
Time frame: Up to 21 days
Days until invasive mechanical ventilation or death, whatever happened first.
5 secondary outcomes
Ventilation
Time frame: Up to 21 days
Death
Time frame: Up to 21 days
Secondary infections
Time frame: Up to 21 days
Digestive tract hemorrhage
Time frame: Up to 21 days
Change in 7 points scale
Time frame: Day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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?
An observational study of COVID-19 Infection, run by Spanish Network for Research in Infectious Diseases at 1 site in Spain.
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 8 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 12 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 Spain. 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 Sánchez-Barriga (+34 600162652, maria.sanchezbarriga@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive ventilation or death (time frame: Up to 21 days). 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 12 May 2020.