Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 6:09 AM
Study NCT ID:
NCT04355793
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2021-12-15
First Post:
2020-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000080424', 'term': 'Cytokine Release Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}, 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2020-04-18', 'studyFirstSubmitQcDate': '2020-04-18', 'lastUpdatePostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Cytokine Storm', 'ruxolitinib'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '40197709', 'type': 'DERIVED', 'citation': 'Weinstein J, Jagan N, Lorthridge-Jackson S, Hamer-Maansson JE, Squier P. Ruxolitinib for Emergency Treatment of COVID-19-Associated Cytokine Storm: Findings From an Expanded Access Study. Clin Respir J. 2025 Apr;19(4):e70050. doi: 10.1111/crj.70050.'}]}, 'descriptionModule': {'briefSummary': 'To provide ruxolitinib through an expanded access program for the treatment of cytokine storm due to COVID-19 in the United States to patients who are eligible but not able to be hospitalized or who are hospitalized with a clinical diagnosis and/or positive test for SARD-CoV-2 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, 12 years of age or older.\n* Clinical diagnosis of COVID-19 and/or locally accepted positive test; if feasible, swab should be taken and saved for quantitative testing to determine viral load.\n* Disease severity making the patient eligible for hospitalization (whether or not hospitalization is available), with evidence of cytokine storm as determined by the treating physician. Manifestations of cytokine storm can include the following:\n* Severe shortness of breath (respiratory rate \\> 24 breaths/minute).\n* SpO2 of \\< 90% on ambient air.\n* Need for invasive or noninvasive mechanical ventilation.\n* Acute respiratory distress syndrome.\n* Multiple organ failure.\n* Be willing to avoid pregnancy or fathering children\n* Able to provide written informed consent, consent from the patient's legally authorized representative, and/or assent from the patient, parent, or guardian.\n\nExclusion Criteria:\n\n* Patients, patient's legally authorized representative, or legal guardians unable to review and sign ICF.\n* Females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant.\n* Patients with inadequate liver function (ALT above 4 × ULN or direct bilirubin 4 × ULN and the laboratory abnormalities are considered to be due to underlying liver dysfunction).\n* Patients with platelet counts \\< 50 × 109 /L\n* Any underlying or current medical or psychiatric condition that, in the opinion of the treating physician, would place the patient at an unacceptable risk if he or she were to participate in the program.\n* Previous allergic reactions to JAK inhibitors or excipients.\n* Concomitant use of any other JAK inhibitor.\n* Is eligible or able to access ruxolitinib through an Incyte-sponsored clinical study or is eligible for another therapeutic clinical trial for cytokine storm at the treating institution.."}, 'identificationModule': {'nctId': 'NCT04355793', 'briefTitle': 'Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'An Open-Label Expanded Access Program of Ruxolitinib for the Emergency Treatment of Cytokine Storm From COVID-19 Infection', 'orgStudyIdInfo': {'id': 'INCB 18424-MA-COVID-19-301'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ruxolitinib', 'type': 'DRUG', 'otherNames': ['INCB018424'], 'description': 'Ruxolitinib starting dose level 5 mg orally, twice daily (BID).'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}