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A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia (MARIPOSA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363736
Recruitment Status : Active, not recruiting
First Posted : April 27, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will assess the pharmacodynamics, pharmacokinetics, safety and efficacy of two different doses of tocilizumab (TCZ) in combination with standard-of-care (SOC) in hospitalized adult participants with moderate to severe COVID-19 pneumonia.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Tociliuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase-II, Open-Label, Randomized, Multicenter Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of 8 mg/kg or 4mg/kg Intravenous Tocilizumab in Patients With Moderate to Severe COVID-19 Pneumonia
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : July 3, 2020
Estimated Study Completion Date : August 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Tocilizumab

Arm Intervention/treatment
Active Comparator: TCZ 8 mg/kg
Participants will receive intravenous (IV) tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
Drug: Tociliuzumab
Participants will receive IV TCZ.

Experimental: TCZ 4 mg/kg
Participants will receive IV tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.
Drug: Tociliuzumab
Participants will receive IV TCZ.




Primary Outcome Measures :
  1. Serum Concentration of interleukin-6 (IL-6) Following Administration of 8 mg/kg IV TCZ [ Time Frame: At pre-defined intervals from first TCZ administration to Day 28 ]
  2. Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R) Following Administration of 8 mg/kg IV TCZ [ Time Frame: At pre-defined intervals from first TCZ administration to Day 28 ]
  3. Serum Concentration of Ferritin Following Administration of 8 mg/kg IV TCZ [ Time Frame: At pre-defined intervals from first TCZ administration to Day 28 ]
  4. Serum Concentration of C-reactive Protein (CRP) Following Administration of 8 mg/kg IV TCZ [ Time Frame: At pre-defined intervals from first TCZ administration to Day 28 ]
  5. Serum Concentration of IL-6 Following Administration of 4 mg/kg IV TCZ [ Time Frame: At pre-defined intervals from first TCZ administration to Day 28 ]
  6. Serum Concentration of sIL-6R Following Administration of 4 mg/kg IV TCZ [ Time Frame: At pre-defined intervals from first TCZ administration to Day 28 ]
  7. Serum Concentration of Ferritin Following Administration of 4 mg/kg IV TCZ [ Time Frame: At pre-defined intervals from first TCZ administration to Day 28 ]
  8. Serum Concentration of CRP Following Administration of 4 mg/kg IV TCZ [ Time Frame: At pre-defined intervals from first TCZ administration to Day 28 ]

Secondary Outcome Measures :
  1. Pecentage of Participants with Adverse Events [ Time Frame: Up to Day 28 ]
  2. Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) (COVID-19) Viral Load Over Time [ Time Frame: Up to Day 28 ]
  3. Time to Real-Time Polymerase Chain Reaction (RT-PCR) Virus Negativity [ Time Frame: Up to Day 28 ]
  4. Proportion of Participants with any Post-Treatment Infection [ Time Frame: Up to Day 28 ]


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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Hospitalization with COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen [e.g., respiratory, blood, urine, stool, and other bodily fluids]) and evidence of pneumonia on chest X-ray or computed tomography scan
  • For severe patients, SpO2 </= 93% or PaO2/FiO2 < 300 mmHg. If a participant is on supplemental oxygen with SpO2 > 93%, but desaturation </= to 93% on lower supplemental oxygen or ambient air is documented during screening, the inclusion criterion is met
  • For moderate patients (those who do not qualify as severe based oxygen requirements), CRP > 2 x upper limit of normal (ULN) is required
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined by the protocol
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined by the protocol

Exclusion Criteria

  • Known severe allergic reactions to TCZ or other monoclonal antibodies
  • Active tuberculosis (TB) infection
  • Suspected active bacterial, fungal, viral, or other infection (besides SARS-CoV-2)
  • Participants who are on a mechanical ventilator > 24 hours or extracorporeal membrane oxygenation (ECMO), in shock, or combination thereof with other organ failure requiring treatment in an ICU
  • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
  • Receipt of oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x ULN detected within 24 hours at screening or at baseline (according to local laboratory reference ranges)
  • Absolute neutrophil count (ANC) < 1000/uL at screening and baseline (according to local laboratory reference ranges)
  • Platelet count < 50,000/uL at screening and baseline (according to local laboratory reference ranges)
  • Pregnancy or breastfeeding, or positive pregnancy test at a predose examination
  • Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days (whichever is longer) of randomization

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): NCT04363736


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04363736    
Other Study ID Numbers: CA42481
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections