A RCT - Safety & Efficacy of Tocilizumab - Tx of Severe COVID-19: ARCHITECTS (ARCHITECTS)
|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: NCT04412772|
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Tocilizumab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Tocilizumab for the Treatment of Severe COVID-19|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Tocilizumab (TCZ) Arm
Participants will receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose may be given if clinical symptoms worsen.
Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen.
Other Name: Actemra
Placebo Comparator: Placebo Arm
Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.
Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.
- Clinical status (on a 7-point ordinal scale) at day 28 [ Time Frame: up to day 28 ]
Clinical Status 7-point ordinal scale:
- Not hospitalized, no limitations on activities
- Not hospitalized, limitation on activities
- Hospitalized, not requiring supplemental oxygen
- Hospitalized, requiring supplemental oxygen
- Hospitalized, on non-invasive ventilation or high flow oxygen devices
- Hospitalized, on invasive mechanical ventilation or ECMO
- Clinical improvement [ Time Frame: up to day 28 ]ii. Time to clinical improvement, defined as a National Early Warning Score (NEWS) of < 2 maintained for 24 hours iii. Time to clinical improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status
- Mechanical Ventilation [ Time Frame: up to day 28 ]iv. Incidence of mechanical ventilation v. Ventilator-free days
- Oxygenation [ Time Frame: up to day 28 ]vi. Duration of time on supplemental oxygen
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): NCT04412772
|Contact: Todd Seto, MD||808 firstname.lastname@example.org|
|Contact: May Vawer, RN||808 email@example.com|
|Principal Investigator:||Todd Seto, MD||The Queen's Medical Center|