A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Latest Information Update: 12 Jul 2023
At a glance
- Drugs Tocilizumab (Primary)
- Indications COVID-19 pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms COVACTA
- Sponsors Roche
- 24 May 2023 Results assessing effect of IL-6R blockade on key immune pathways associated with severe COVID-19, presented at the 119th International Conference of the American Thoracic Society
- 04 Apr 2022 According to a Genentech media release, A decision on U.S. FDA approval is expected in the second half of this year.
- 04 Apr 2022 According to a Genentech media release, the U.S. FDA has accepted the company's supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Most Recent Events
Trial Overview
Outcome
Purpose
This placebo-controlled Phase III study (COVACTA) is designed to evaluate the safety and efficacy of intravenous Actemra/RoActemra added to standard of care in adult patients hospitalised with severe COVID-19 pneumonia compared to placebo plus standard of care.
Patients will be followed for 60 days post-randomisation, and an interim analysis will be conducted to look for early evidence of efficacy.
Comments
In April 2022, The U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). A decision on U.S. FDA approval is expected in the second half of this year.
According to a Chugai Pharmaceutical media release, the company received regulatory approval from the Ministry of Health, Labour and Welfare for Actemra Intravenous Infusion 80 mg, 200 mg, and 400 mg for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention), based on results from COVACTA, EMPACTA, REMDACTA, J-COVACTA and RECOVERY studies.
According to Roche media release, the European Commission has extended the marketing authorisation for Actemra®/RoActemra® (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. The decision from the European Commission follows an accelerated assessment by the EMA's CHMP, which reviewed results from four studies of Actemra/RoActemra ( RECOVERY, EMPACTA, COVACTA and REMDACTA studies) in over 5,500 patients with severe or critical COVID-19.
According to a Genentech media release, U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).Data from RECOVERY, EMPACTA, COVACTA and REMDACTA studies was included in the EUA submission.
Primary Endpoints
Clinical Status Assessed Using a 7-Category Ordinal Scale
time_frame: Day 28 [1]
Other Endpoints
Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours
description: Defined as time from first dose of study drug to at least two NEWS2 assessments with a score of ≤2 covering a span of at least 21.5 hours, with a maximum of 26.5 hours between the first and last of these assessments and no assessments with a score >2 in between. If one of the components of the NEWS2 score was missing at a particular time point, then the NEWS2 score was not calculated. Participants who died were censored at Day 28.
time_frame: Up to Day 28
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
description: Time to improvement for this outcome measure was defined as the days from the first dose of study drug to when at least a 2-category improvement in clinical status (based on a 7-category ordinal scale) is observed. Participants who died were censored at Day 28.
time_frame: Up to Day 28
Time to Hospital Discharge or "Ready for Discharge"
description: Time to Hospital Discharge was defined as the time from the first dose of study drug to hospital discharge or "ready for discharge" (normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or </=2L supplemental oxygen) Participants who died were censored at Day 28.
time_frame: Up to Day 28
Incidence of Mechanical Ventilation by Day 28
description: Participants who died by Day 28 were assumed to have required mechanical ventilation.
time_frame: Up to Day 28
Ventilator-Free Days to Day 28
description: Participants who died by Day 28 were assigned 0 ventilator-free days.
time_frame: Up to Day 28
Incidence of Intensive Care Unit (ICU) Stay by Day 28 (Week 4)
description: Participants who died by Day 28 were assumed to have required an ICU stay.
time_frame: Up to Day 28
Duration of ICU Stay to Day 28 (Week 4)
description: Participants who died by Day 28 were assigned a duration from the first dose of study drug to Day 28 at hour 23:59:59.
time_frame: Up to Day 28
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14
description: Clinical status was assessed using a 7-category ordinal scale:
- Discharged (or "ready for discharge")
- Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen
- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen
- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen
- ICU, requiring intubation and mechanical ventilation
- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support
- Death
time_frame: Day 14
Time to Clinical Failure to Day 28 (Week 4)
description: Time to clinical failure was defined as the number of days from the first dose of study drug to the first occurrence on study of death, mechanical ventilation, ICU admission, or study withdrawal prior to discharge, whichever occurs first.
time_frame: Up to Day 28
Mortality Rate at Day 28 (Week 4)
time_frame: Day 28
Time to Recovery to Day 28 (Week 4)
description: Time to recovery was defined as the number of days from the first dose of study drug to hospital discharge or "ready for discharge" (normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or </= 2L supplemental oxygen) or non-ICU hospital ward or "ready for hospital ward" not requiring supplemental oxygen. Participants who died were censored at Day 28.
time_frame: Up to Day 28
Duration of Supplemental Oxygen to Day 28 (Week 4)
description: Participants who died by Day 28 were assigned a duration of 28 days of supplemental oxygen.
time_frame: Up to Day 28 [2]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID-19 pneumonia | treatment | severe |
Subjects
- Subject Type patients
-
Number
Planned: 450
Actual: 452
- Sex male & female
- Age Group ≥ 18 years; adult
Patient Inclusion Criteria
- Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan - SPO2 </=93% or PaO2/FiO2 <300 mmHg
Patient 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 COVID-19) - In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments - Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 3 months - Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor) - Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination - Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medial Monitor) - Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab) - Absolute neutrophil count (ANC) < 1000/mL at screening (per local lab) - Platelet count < 50,000/mL at screening (per local lab)
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT04320615 | ClinicalTrials.gov: US National Institutes of Health |
| EudraCT2020-001154-22 | European Clinical Trials Database |
| 13593711 | ISRCTN: Current Controlled Trials |
| WA42380 | Roche |
| HHSO100201800036C | - |
Organisations
- Sponsors Roche
- Affiliations Chugai Pharmaceutical; Genentech; Roche
Trial Dates
-
Initiation Dates
Planned : 03 Apr 2020
Actual : 03 Apr 2020
-
Primary Completion Dates
Planned : 31 Aug 2020
Actual : 24 Jun 2020
-
End Dates
Planned : 30 Sep 2020
Actual : 28 Jul 2020
Other Details
- Design double-blind; multicentre; parallel; prospective; randomised
- Phase of Trial Phase III
- Location Canada; Denmark; England; France; Germany; Ireland; Italy; Netherlands; Scotland; Spain; Sweden; Switzerland; United Kingdom; USA
- Focus Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| TocilizumabPrimary Drug | Intravenous | Infusion |
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 or show no improvement.
Drug: Tocilizumab (TCZ) (Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement.)
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 or show no improvement.
Drug: Placebo (Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.)
Results
Therapeutic efficacy
Pneumonia (associated with COVID-2019)
Results from the phase III COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia and the key secondary endpoint which included the difference in patient mortality at week four, were not met. A positive trend in time to hospital discharge was observed in tocilizumab patients. Tocilizumab and placebo in patients assessed using a 7-category ordinal scale at week four was not statistically significant (p=0.36; odds ratio [95% CI] = 1.19 [0.81, 1.76]. There was no difference between tocilizumab and placebo in the percentage of patients that died by week four (tocilizumab = 19.7% and placebo = 19.4% with a difference [95% CI] of 0.3% [-7.6%, 8.2%], p=0.9410). Time to hospital discharge or ‘ready to discharge’ was shorter in patients treated with tocilizumab than in those treated with placebo. The median time to discharge or ‘ready to discharge’ for tocilizumab was 20 days and for placebo was 28 days (median time [95% CI]: tocilizumab = 20.0 [17.0, 27.0]; placebo = 28.0 [20.0, NE], p=0.0370). The difference in ventilator-free days between tocilizumab and placebo was not statistically significant (median of 22 days for tocilizumab and 16.5 days with placebo, difference in medians [95% CI] = 5.5 [-2.8, 13.0], p=0.3202). At week four, rates of infections were 38.3% and 40.6% in the tocilizumab and placebo arms, respectively, and the rates of serious infections were 21.0% and 25.9% in the tocilizumab and placebo arms, respectively [3] .
Adverse events
Pneumonia (associated with COVID-2019): Results from the phase III COVACTA trial in patients with severe COVID-19 pneumonia showed no new safety signals for tocilizumab. The most common adverse events in tocilizumab patients were COVID-19 pneumonia (10.5%), hypertension (6.4%), pneumonia, acute kidney injury and diarrhea (5.8% each). The trial enrolled 450 patients [1] .
2023-10-11 10:15:44.250
Publications
-
Genentech. Genentech Provides an Update on the Phase III COVACTA Trial of Actemra in Hospitalized Patients With Severe COVID-19 Associated Pneumonia. Media-Rel 2020;.
Media Release -
Roche. Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia. Media-Rel 2020;.
Media Release -
Chugai Pharmaceutical. Chugai Provides an Update on Phase III COVACTA Study of Actemra in Hospitalized Patients with Severe COVID-19 Associated Pneumonia. Media-Rel 2020;.
Media Release -
Rosas IO, Brau N, Waters M, Go RC, Hunter BD, Bhagani S, et al. Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia. . N-Engl-J-Med 2021;.
PubMed | CrossRef Fulltext -
Bauer RN, Hackney J, Rosenberger C, Teterina A, Qamra A, Onabajo O, et al. Tocilizumab Treatment Leads to Early Resolution of Myeloid Dysfunction and Lymphopenia in Patients Hospitalized With COVID-19. ATS-2023 2023; abstr. N/A.
Available from: URL: https://www.abstractsonline.com/pp8/#!/10703/presentation/8922
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
|
Clinical Trials
1 DNA Way South San Francisco 94080 United States of America +1 (0)888 662 6728 global-roche-genentech-trials@gene.com
show details
https://www.roche.com/about_roche/roche_worldwide.htm |
Hoffmann-La Roche | USA |
|
Reference Study ID Number: WA42380 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 global-roche-genentech-trials@gene.com
show details
|
-
|
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| - |
-
|
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| Amphia Ziekenhuis | Breda | Netherlands |
| ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco | Milano, Lombardia | Italy |
| ASST Papa Giovanni XXIII; Dipartimento Interaziendale di Farmacia Clinica | Bergamo, Lombardia | Italy |
| Azienda Ospedaliera Dei Colli | Napoli, Campania | Italy |
| Azienda Ospedaliera San Gerardo di Monza | Monza MI, Lombardia | Italy |
| Baylor St. Luke's Medical Center | Houston, Texas | USA |
| Baystate Health System | Springfield, Massachusetts | USA |
| Ben Taub General Hospital - HCHD | Houston, Texas | USA |
| Centre Hospitalier Departemental de Vendee | La Roche Sur Yon | France |
| Centre Hospitalier et Universitaire de Limoges | Limoges | France |
| CHRU de Tours, Pharmacie | Tours | France |
| Cleveland Clinic Foundation; Pulmonary, Allergy & Critical Care Medicine | Cleveland, Ohio | USA |
| Clinical Research Institute of Montreal | Montreal, Quebec | Canada |
| David Geffen School of Medicine UCLA | Los Angeles, California | USA |
| Denver Health Medical Center | Denver, Colorado | USA |
| Duke University Medical Center | Durham, North Carolina | USA |
| Erasmus MC | Rotterdam | Netherlands |
| eStudySite | La Mesa, California | USA |
| Evergreen Health Infectious Disease | Kirkland, Washington | USA |
| F. Hoffmann-La Roche Ltd |
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| Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria | Pavia, Lombardia | Italy |
| Greater Glasgow and Clyde Health Board | Glasgow | United-Kingdom |
| Hackensack University Medical Center | Hackensack, New Jersey | USA |
| Hoffmann-La Roche | San Francisco | USA |
| HOPITAL COCHIN university hospital | Paris | France |
| Hopital de la Pitie Salpetriere | Paris | France |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario de Bellvitge | Hospitalet de Llobregat, Barcelona | Spain |
| Hospital Universitario HM Sanchinarro-CIOCC | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | Spain |
| Hotel Dieu - Nantes | Nantes | France |
| Hvidovre Hospital | Hvidovre | Denmark |
| Hôpital de La Croix Rousse | Lyon | France |
| Imperial College London | London | United-Kingdom |
| Intermountain LDS Hospital | Salt Lake City, Utah | USA |
| Intermountain Medical Group | Saint George, Utah | USA |
| Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS | Roma, Lazio | Italy |
| James J Peters Veterans Administration Medical Center - NAVREF | Bronx, New York | USA |
| Leeds Teaching Hospitals NHS Trust | Leeds | United-Kingdom |
| LMU Klinikum der Universitat Munchen | Munchen | Germany |
| Mayo Clinic - PPDS | Rochester, Minnesota | USA |
| McMaster University Medical Centre | Hamilton, Ontario | Canada |
| Medizinische Hochschule Hannover | Hannover | Germany |
| New York University Langone Medical Center | New York, New York | USA |
| North Manchester General Hospital | Manchester | United-Kingdom |
| NYU-Langone Medical Center | New York, New York | USA |
| Ochsner Clinic Foundation | Baton Rouge, Louisiana | USA |
| Odense Universitetshospital | Odense C | Denmark |
| Rigshospitalet Copenhagen University Hospital | Copenhagen | Denmark |
| Robert Wood Johnson University Hospital/Rutgers | New Brunswick, New Jersey | USA |
| Royal Free Hospital | London | United-Kingdom |
| Rush University Medical Center | Chicago, Illinois | USA |
| Salford Royal Hospital | Salford | United-Kingdom |
| Sjællands Universitetshospital, Roskilde | Roskilde | Denmark |
| Smith Clinic-Harris County Hospital | Houston, Texas | USA |
| St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | Netherlands |
| Stanford University | Stanford, California | USA |
| Swedish Hospital Medical Center | Seattle, Washington | USA |
| Thomas Jefferson University | Philadelphia, Pennsylvania | USA |
| Toronto Western Hospital | Toronto, Ontario | Canada |
| Uniklinik Köln | Köln | Germany |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands |
| Universitatsklinikum Dusseldorf | Dusseldorf | Germany |
| Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin | Kiel | Germany |
| University Health Network | Toronto, Ontario | Canada |
| University of California San Diego | La Jolla, California | USA |
| University of Chicago | Chicago, Illinois | USA |
| University of Miami Miller School of Medicine | Miami, Florida | USA |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 24 May 2023 | Results | Results assessing effect of IL-6R blockade on key immune pathways associated with severe COVID-19, presented at the 119th International Conference of the American Thoracic Society Updated 12 Jul 2023 |
| 13 Apr 2022 | Other trial event | Last checked against European Clinical Trials Database record. Updated 13 Apr 2022 |
| 04 Apr 2022 | Other trial event | According to a Genentech media release, A decision on U.S. FDA approval is expected in the second half of this year. Updated 08 Apr 2022 |
| 04 Apr 2022 | Other trial event | According to a Genentech media release, the U.S. FDA has accepted the company's supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Updated 08 Apr 2022 |
| 21 Jan 2022 | Other trial event | According to a Chugai Pharmaceutical media release, the company received regulatory approval from the Ministry of Health, Labour and Welfare for Actemra Intravenous Infusion 80 mg, 200 mg, and 400 mg for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention), based on results from COVACTA, EMPACTA, REMDACTA, J-COVACTA and RECOVERY studies. Updated 27 Jan 2022 |
| 07 Dec 2021 | Other trial event | According to Roche media release, the European Commission has extended the marketing authorisation for tocilizumab to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. The decision from the European Commission follows an accelerated assessment by the EMAs CHMP, which reviewed results from four studies of Actemra/RoActemra ( RECOVERY, EMPACTA, COVACTA and REMDACTA studies). Updated 13 Dec 2021 |
| 15 Jul 2021 | Other trial event | This trial has been completed in Italy, according to European Clinical Trials Database record. Updated 15 Jul 2021 |
| 07 Jul 2021 | Other trial event | Last checked against Clinicaltrials.gov record. Updated 07 Jul 2021 |
| 24 Jun 2021 | Other trial event | According to a Genentech media release, U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.Data from RECOVERY, EMPACTA, COVACTA and REMDACTA studies was included in the EUA submission. Updated 01 Jul 2021 |
| 25 Feb 2021 | Results | Results published in the New England Journal of Medicine Updated 05 Mar 2021 |
| 27 Jan 2021 | Other trial event | New source identified and integrated (ISRCTN: Current Controlled Trials record 13593711). Updated 27 Jan 2021 |
| 29 Jul 2020 | Results | Results presented in a Chugai Pharmaceutical Media Release. Updated 04 Aug 2020 |
| 29 Jul 2020 | Results | Results published in the Roche Media Release Updated 31 Jul 2020 |
| 29 Jul 2020 | Status change - completed | Status changed from active, no longer recruiting to completed, according to a Genentech media release. Updated 30 Jul 2020 |
| 29 Jul 2020 | Other trial event | According to a Genentech media release, further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal. Updated 30 Jul 2020 |
| 29 Jul 2020 | Results | Results published in the Genentech Media Release. Updated 30 Jul 2020 |
| 29 Jul 2020 | Endpoint not met | Primary endpoint has not been met. (Clinical Status Assessed Using a 7-Category Ordinal Scale), according to a Genentech media release. Updated 30 Jul 2020 |
| 28 May 2020 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 02 Jun 2020 |
| 28 May 2020 | Other trial event | According to an Roche media release, the data from the REMDACTA trial are designed to this study. Updated 29 May 2020 |
| 28 May 2020 | Other trial event | According to an Roche media release, the increase in original target of 330 patients to 450 patients will allow for even more robust data, while minimally extending the recruitment period. In addition, the protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals. Updated 29 May 2020 |
| 28 May 2020 | Other trial event | According to an Roche media release, this study is close to completing enrolment. The first patient in this study was randomised on April 3, 2020. Updated 29 May 2020 |
| 06 May 2020 | Other trial event | Planned number of patients changed from 330 to 450. Updated 06 May 2020 |
| 22 Apr 2020 | Completion date | Planned End Date changed from 30 Sep 2021 to 30 Sep 2020. Updated 27 Apr 2020 |
| 22 Apr 2020 | Other trial event | Planned primary completion date changed from 31 Aug 2021 to 31 Aug 2020. Updated 27 Apr 2020 |
| 22 Apr 2020 | Other trial event | According to a Roche media release, results from this study are expected in early summer. Updated 23 Apr 2020 |
| 06 Apr 2020 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 09 Apr 2020 |
| 06 Apr 2020 | Other trial event | New source identified and integrated (European Clinical Trials Database;EudraCT2020-001154-22). Updated 06 Apr 2020 |
| 27 Mar 2020 | Other trial event | New source identified and integrated (ClinicalTrials.gov record: NCT04320615). Updated 27 Mar 2020 |
| 23 Mar 2020 | Status change - not yet recruiting | Status changed from planning to not yet recruiting. Updated 27 Mar 2020 |
| 23 Mar 2020 | Other trial event | According to a Genentech media release, the U.S. Food and Drug Administration (FDA) has approved this trial. The company is moving forward to enroll as quickly as possible. Updated 24 Mar 2020 |
| 19 Mar 2020 | Other trial event | According to a Roche media release, an interim analysis will be conducted to look for early evidence of efficacy.This is the first global study of Actemra/RoActemra in this setting and is expected to begin enrolling as soon as possible in early April. Updated 19 Mar 2020 |
| 19 Mar 2020 | Other trial event | According to a Roche media release, the company is working with the FDA to initiate this Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR). Updated 19 Mar 2020 |
| 19 Mar 2020 | New trial record | New trial record Updated 19 Mar 2020 |
Table of Contents
References
-
Genentech. Genentech Provides an Update on the Phase III COVACTA Trial of Actemra in Hospitalized Patients With Severe COVID-19 Associated Pneumonia. Media-Rel 2020;.
Media Release -
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Available from: URL: http://clinicaltrials.gov -
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Media Release -
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Media Release -
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PubMed | CrossRef Fulltext -
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Genentech. Genentechs Actemra Receives FDA Emergency Use Authorization for the Treatment of COVID-19 In Hospitalized Adults and Children. Media-Rel 2021;.
Media Release -
Roche. Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir in hospitalised patients with severe COVID-19 pneumonia. Media-Rel 2020;.
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Genentech. U.S. FDA Grants Priority Review to Genentechs Actemra for the Treatment of COVID-19 in Hospitalized Adults. Media-Rel 2022;.
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Genentech. Genentech Announces FDA Approval of Clinical Trial for Actemra to Treat Hospitalized Patients With Severe COVID-19 Pneumonia. Media-Rel 2020;.
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