Immunosupressive Treatment in COVID-19 Patients

COVID-19 Infection Clinical Trial

— SAM-COVID  

Official title:

Effect of Immunosupressive Treatment in COVID-19 Patients Whit SAM-LIKE Profile: Retrospective Cohort Study (SAM-COVID Project)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04382781
• Other study ID #: FIS-INM-2020-03
• Status: Recruiting
• Start date: May 2020
• Est. completion date: May 2020

Study information

• Verified date: May 2020
• Source: Spanish Network for Research in Infectious Diseases
• Contact: Sánchez-Barriga
• Phone: +34 600162652
• Email: maria.sanchezbarriga[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19 Infection

Intervention

Drug:
• NO-Immunosuppressive
Patients not receiving immunosuppressive drugs
• Immunosuppressive
Patients receiving immunosuppressive drugs (overall, and specific drugs)
• Immunoglubulins
Patients receiving immunoglubulins

Locations

Country	Name	City	State
Spain	Hospital Virgen Macarena	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Network for Research in Infectious Diseases	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive ventilation or death	Days until invasive mechanical ventilation or death, whatever happened first.	Up to 21 days
Secondary	Ventilation	Days until mechanical ventilation	Up to 21 days
Secondary	Death	Days until death	Up to 21 days
Secondary	Secondary infections	Proportion of patients developing secondary infections	Up to 21 days
Secondary	Digestive tract hemorrhage	Proportion of patients with digestive tract hemorrhage	Up to 21 days
Secondary	Change in 7 points scale	Proportion of patients with imnprovement in 2 or more points in 7-point scale by WHO	Day 21