SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19
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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: NCT04355494 |
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Expanded Access Status :
No longer available
First Posted : April 21, 2020
Last Update Posted : March 9, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| COVID-19 Pneumonia, Viral Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) | Biological: eculizumab |
This is an open label, multicenter, Expanded Access Program (EAP) to allow participants with a confirmed diagnosis of SARS-CoV-2 infection, and a clinical presentation consistent with COVID-19 severe pneumonia, acute lung injury, or ARDS to be treated with eculizumab. Participants admitted to a designated hospital facility who qualify for emergency treatment will be administered eculizumab up to 7 times during their treatment course (5 mandatory doses and up to 2 optional doses, per Investigator assessment).
The EAP consists of a Screening Period of up to 7 days, a 4-week Treatment Period, a final in-hospital assessment on Day 29 or day of discharge, whichever occurs first, and 3 monthly safety follow up visits (to be conducted as a telephone call if the participant has been discharged from the hospital or an in-person visit if the participant is still hospitalized).
For each participant, the total duration of the program is anticipated to be 4.5 months.
| Study Type : | Expanded Access |
| Expanded Access Type : | Intermediate-size Population |
| Official Title: | SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID 19) - An Expanded Access Program for Hospital-based Emergency Treatment |
- Biological: eculizumab
Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)Other Name: Soliris
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
Inclusion Criteria:
- Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent.
- Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
- Symptomatic, bilateral pulmonary infiltrates confirmed by CT or X-ray at Screening or within the 7 days prior to Screening
- Severe pneumonia, acute lung injury, or ARDS requiring oxygen supplementation
Exclusion Criteria:
- Confirmed diagnosis of SARS-CoV-2 infection presenting as mild to moderate COVID-19, even if the participant is hospitalized
- Participant is not expected to survive more than 24 hours
- Participant has an unresolved Neisseria meningitidis infection
- Hypersensitivity to murine proteins or to one of the excipients of Soliris
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): NCT04355494
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Newton-Wellesley Hospital | |
| Newton, Massachusetts, United States, 02462 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New Jersey | |
| Robert Wood Johnson University Hospital | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Icahn School of Medicine at Mount Sinai | |
| New York, New York, United States, 10029 | |
| United States, Ohio | |
| The Ohio State University Wexner Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| France | |
| Hôpital Henri Mondor | |
| Creteil, France, 94000 | |
| Hôpital Garches Raymond Poincaré | |
| Garches, France, 92380 | |
| Hôpital de Bicêtre | |
| Le Kremlin Bicêtre, France, 94275 | |
| Hôpital Saint Louis | |
| Paris, France, 75010 | |
| Hôpital Paul Brousse | |
| Villejuif, France, 94800 | |
| Responsible Party: | Alexion Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04355494 |
| Other Study ID Numbers: |
ECU-COV-401 |
| First Posted: | April 21, 2020 Key Record Dates |
| Last Update Posted: | March 9, 2021 |
| Last Verified: | March 2021 |
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acute lung injury acute respiratory distress syndrome antibodies, monoclonal, humanized complement inhibition COVID-19 eculizumab emergency treatment expanded access program |
hospitalization pneumonia severe acute respiratory syndrome severe acute respiratory syndrome coronavirus 2 severe pneumonia Soliris viral |
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COVID-19 Pneumonia Pneumonia, Viral Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Lung Injury Syndrome Disease Pathologic Processes Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries Eculizumab Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |