Immunosupressive Treatment in COVID-19 Patients (SAM-COVID)

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19 Infection
• Intervention / Treatment: Drug: NO-Immunosuppressive; Drug: Immunosuppressive; Drug: Immunoglubulins

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Sánchez-Barriga; Phone Number: +34 600162652; Email: maria.sanchezbarriga@juntadeandalucia.es

Study Locations

• Spain
  • Sevilla, Spain, 41071
    • Recruiting
    • Hospital Virgen Macarena
    • Principal Investigator: Jesús Rodriguez-Baño, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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 .

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 .	Drug: NO-Immunosuppressive; Patients not receiving immunosuppressive drugs; Drug: Immunosuppressive; Patients receiving immunosuppressive drugs (overall, and specific drugs); Drug: Immunoglubulins; Patients receiving immunoglubulins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive ventilation or death	Days until invasive mechanical ventilation or death, whatever happened first.	Up to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation	Days until mechanical ventilation	Up to 21 days
Death	Days until death	Up to 21 days
Secondary infections	Proportion of patients developing secondary infections	Up to 21 days
Digestive tract hemorrhage	Proportion of patients with digestive tract hemorrhage	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	Day 21

Collaborators and Investigators

• Sponsor: Spanish Network for Research in Infectious Diseases
• Collaborators: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Immunosuppressive; Immunoglubulins
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Immunosuppressive Agents
• Other Study ID Numbers: FIS-INM-2020-03