Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-03 @ 6:34 PM
Study NCT ID:
NCT04323761
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2020-11-13
First Post:
2020-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606551', 'term': 'remdesivir'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}, 'nPtrsToThisExpAccNctId': 5}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'statusVerifiedDate': '2020-11', 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['SARS-CoV2 Infection']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age), or willing and able to provide assent (participants ≥ 12 and \\< 18 years of age, where locally and nationally approved) prior to performing study procedures. For participants ≥ 12 and \\< 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures.\n* Age ≥ 18 years or aged ≥ 12 and \\< 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC))\n* Hospitalized with confirmed SARS-CoV2 by polymerase chain reaction (PCR) or known contact of confirmed case with syndrome consistent with coronavirus disease (COVID-19) with PCR pending\n* Oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen at baseline\n* Alanine aminotransferase (ALT) \\< 5 x upper limit of normal (ULN) by local laboratory measure and/or ALT \\< 3 x ULN and bilirubin \\< 2 x ULN\n* Females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception\n* Lactating females must agree to discontinue nursing before the study drug is administered and while they are participating in the study\n\nExclusion Criteria:\n\n* Evidence of multiorgan failure including but not limited to coagulopathy (significant thrombocytopenia), hepatic failure (elevated bilirubin) or renal failure (low urine output or estimated glomerular filtration rate (eGFR) \\< 30 mL/min), or significant cardiomyopathy (low cardiac output)\n* Use of more than 1 pressor for septic shock (note that use of 1 pressor at low/medium doses for inotropic support due to the use of sedation and paralytics while on the ventilator is allowed)\n* Renal failure (eGRF \\< 30 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age and Schwartz Formula for participants \\< 18 years of age) or dialysis or continuous Veno-Venous Hemofiltration)\n* Eligible for enrollment in a randomized clinical trial studying remdesivir for treatment of SARS-CoV2 at the medical facility where the participant is admitted\n* Known hypersensitivity to the study drug, the metabolites, or formulation excipient\n* Requiring venous arterial (V-A) extracorporeal membrane oxygen (ECMO) (venous venous (V-V) ECMO is not an exclusion criteria)'}, 'identificationModule': {'nctId': 'NCT04323761', 'briefTitle': 'Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection', 'orgStudyIdInfo': {'id': 'GS-US-540-5821'}, 'secondaryIdInfos': [{'id': '2020-001453-49', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Remdesivir', 'type': 'DRUG', 'otherNames': ['GS-5734™', 'Veklury®'], 'description': 'Intravenous infusion administered over a 30 to 120 minute period'}]}, 'contactsLocationsModule': {'locations': [{'zip': 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