Skip to main content
OpenTrials
Completed

NCT Number: NCT04363736

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic - Arizona, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tociliuzumab

Drug

Participants will receive IV TCZ.

Primary outcomes

  1. Area Under the Curve From Day 0-28 (AUC0-d28) of Tocilizumab)

    Time frame: Days 0-28. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.

  2. Maximum Serum Concentration (Cmax) of Tocilizumab

    Time frame: Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.

  3. Clearance (CL) of Tocilizumab

    Time frame: Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.

  4. Volume of the Central Compartment (Vc) of Tocilizumab

    Time frame: Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.

  5. Serum Concentration of C-reactive Protein (CRP) Following Administration of IV TCZ

    Time frame: Baseline - Day 60

  6. Serum Concentration of Ferritin Following Administration of IV TCZ

    Time frame: Baseline - Day 60

  7. Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R) Following Administration of IV TCZ

    Time frame: Baseline - Day 60

  8. Serum Concentration of Interleukin-6 (IL-6) Following Administration of IV TCZ

    Time frame: Baseline - Day 60

Secondary outcomes

  1. Pecentage of Participants With Adverse Events

    Time frame: Up to Day 60

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

  2. Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) (COVID-19) Viral Load Over Time

    Time frame: Baseline - Day 60

  3. Time to Real-Time Polymerase Chain Reaction (RT-PCR) Virus Negativity

    Time frame: Up to Day 28

    Time to Real-Time Polymerase Chain Reaction (RT-PCR) virus negativity was defined as the number of days from the first dose of study drug to when a negative RT-PCR SARS-CoV-2 assessment result was observed. Results are presented as a cumulative incidence function (CIF) with death as a competing risk.

  4. Proportion of Participants With Any Post-Treatment Infection

    Time frame: Up to Day 60

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: MARIPOSA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2020
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.