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Tocilizumab Treatment in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363853
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico

Brief Summary:
A phase II clinical trial will be carried out with the objective of studying the impact of the administration of Tocilizumab on the evolution of the acute respiratory distress syndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection. Due to the high mortality of severe forms of SARS-CoV-2 and for ethical reasons, a control arm will not be included. Patients will be recruited by signing an informed consent and the baseline variables of interest will be recorded. Tocilizumab will be administered in one or two doses, depending on the case, and will be followed up for 30 days. The response to treatment, survival and evolution will be studied. Factors associated with improvement of ARDS and survival will be identified through multivariate analyzes. The results will be compared with those reported internationally.

Condition or disease Intervention/treatment Phase
Sars-CoV2 Drug: Tocilizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase II, single-arm, open-label, prospective, blinded, clinical trial with Tocilizumab as the sole agent.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Serious and Critical Patients With COVID-19 With Tocilizumab
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arm Intervention/treatment
Experimental: Tocilizumab tratment Drug: Tocilizumab
We study the impact of the administration of Tocilizumab on the evolution of the acute respiratory distress syndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection.




Primary Outcome Measures :
  1. Hematic biometry [ Time Frame: 24 hours ]
    Until removal of mechanical ventilation, Control of hemoglobin, hematocrit, platelet , and leukocytes levels.

  2. Blood chemistry [ Time Frame: 24 hours ]
    Until removal of mechanical ventilation. Control of glucose, uric acid, cholesterol, urea, triglycerides, and creatinine.

  3. Blood gas [ Time Frame: 24 hours ]
    Until removal of mechanical ventilation. Control metabolic and repiratory alcalosis or acidosis.

  4. Hematic biometry [ Time Frame: 48 hours ]
    Until removal of mechanical ventilation, Control of hemoglobin, hematocrit, platelet , and leukocytes levels.

  5. Blood chemistry [ Time Frame: 48 hours ]
    Until removal of mechanical ventilation. Control of glucose, uric acid, cholesterol, urea, triglycerides, and creatinine.

  6. blood gas [ Time Frame: 48 hours ]
    Until removal of mechanical ventilation. Control metabolic and repiratory alcalosis or acidosis.

  7. Hematic biometry [ Time Frame: 72 hours ]
    Until removal of mechanical ventilation, Control of hemoglobin, hematocrit, platelet , and leukocytes levels.

  8. Blood chemistry [ Time Frame: 72 hours ]
    Until removal of mechanical ventilation. Control of glucose, uric acid, cholesterol, urea, triglycerides, and creatinine.

  9. blood gas [ Time Frame: 72 hours ]
    Until removal of mechanical ventilation. Control metabolic and repiratory alcalosis or acidosis.

  10. Hematic biometry [ Time Frame: 7 days ]
    Until removal of mechanical ventilation, Control of hemoglobin, hematocrit, platelet , and leukocytes levels.

  11. Blood chemistry [ Time Frame: 7 days ]
    Until removal of mechanical ventilation. Control of glucose, uric acid, cholesterol, urea, triglycerides, and creatinine.

  12. blood gas [ Time Frame: 7 days ]
    Until removal of mechanical ventilation. Control metabolic and repiratory alcalosis or acidosis.

  13. Hematic biometry [ Time Frame: 14 days ]
    Until removal of mechanical ventilation, Control of hemoglobin, hematocrit, platelet , and leukocytes levels.

  14. Blood chemistry [ Time Frame: 14 days ]
    Until removal of mechanical ventilation. Control of glucose, uric acid, cholesterol, urea, triglycerides, and creatinine.

  15. blood gas [ Time Frame: 14 days ]
    Until removal of mechanical ventilation. Control metabolic and repiratory alcalosis or acidosis.

  16. thorax radiography [ Time Frame: 24 hours ]
    Until removal of mechanical ventilation. Monitoring for signs of pneumonia imaging.

  17. thorax radiography [ Time Frame: 7 days ]
    Until removal of mechanical ventilation. Monitoring for signs of pneumonia imaging.

  18. thorax radiography [ Time Frame: 14 days ]
    Until removal of mechanical ventilation. Monitoring for signs of pneumonia imaging.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients 18 years or older
  • Diagnosis of SARS-CoV-2 infection by RT-PCR
  • Diagnosis of serious or critical illness, without mechanical ventilation or with less than 24 hours of mechanical ventilation.
  • Severe: dyspnea, increase in respiratory rate ≥ 30 breaths / min, oxygen saturation <90% or PaO2 <60 mmHg or increase in supplemental oxygen requirement more than 3% from baseline, PaO2 / FiO2 <300 mmHg, and / or pulmonary infiltrates by image> 50% within 24 to 48 hours of symptom onset.
  • Critical: respiratory failure (alteration in gas exchange with PaO2 <60 mmHg with or without elevation of PaCO2> 33 mmHg), septic shock (hypotension secondary to sepsis with a requirement for vasopressors to maintain a mean arterial pressure> 65 mmHg and lactate> 2 mmol / l).
  • Signature of informed consent by the patient, family member or legal representative
  • Negative pregnancy test for women of childbearing age.
  • Male patients who agree to use barrier methods when having sexual intercourse in the following 80 days after receiving tocilizumab
  • Patients receiving immunomodulatory treatment (cancer, transplant recipients or other diseases) that may temporarily suspend the drug.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Patients who by indication of their treating doctor cannot suspend previous immunomodulatory treatment.
  • Known allergic reactions to Tocilizumab or any excipients.
  • Patients receiving systemic steroids at a dose greater than 1 mg / Kg of weight per day in prednisone equivalents
  • Patients with SOFA score> 15 points that predicts 90% mortality on admission
  • The decision of the attending physician not to include the patient due to the presence of any condition that does not allow the administration of the drug to be safe.
  • Diverticulitis or intestinal perforation
  • Patients with any of the following active infections: viral hepatitis, tuberculosis, HIV infection, bacterial and/or fungal and/or viral infections (other than SARS-CoV-2 infection) suspected or diagnosed using compatible microbiological isolation.
  • Alanine aminotransferase/aspartate aminotransferase values> 5 times the upper limit of normal
  • Neutrophil values <1000/ml,
  • Platelet values <50,000/ml.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363853


Locations
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Mexico
National Cancer Institute of Mexico Recruiting
Mexico city, Distrito Federal, Mexico, 14080
Contact: Oscar G Arrieta, MD M Sc.    56 28 04 00 ext 71101    ogar@unam.mx   
Contact: Diana Flores Estrada    56 28 04 00 ext 71104    clinicacancerpulmonincan@gmail.com   
Principal Investigator: Oscar G Arrieta, Oncologist         
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Roche Pharma AG
Publications:

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Responsible Party: Oscar Gerardo Arrieta Rodríguez, MD MSc Head of Thoracic Oncology Unit, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT04363853    
Other Study ID Numbers: INF-3343-20-22-1
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data wil be avaible in july 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No