Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
Study NCT ID:
NCT04302766
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-02-17
First Post:
2020-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access Remdesivir (RDV; GS-5734™)
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-23', 'size': 107073, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-29T11:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True, 'intermediate': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'lastUpdateSubmitDate': '2022-02-15', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['COVID-19', 'GS-5734', 'Remdesivir', 'SARS-CoV-2'], 'conditions': ['Coronavirus Disease 2019']}, 'descriptionModule': {'briefSummary': 'Disease caused by 2019 Novel Coronavirus also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)', 'detailedDescription': 'The treatment of communicable Novel Coronavirus (CODIV-19) of 2019 with Remdesivir (RDV; GS-5734™) also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DoD-affiliated personnel as defined in DoDI 6200.02, which includes emergency-essential civilian employees and/or contractor personnel accompanying the Armed Forces who are subject to the same health risk as military personnel\n* Have a laboratory-confirmed COVID-19 diagnosis with moderate to severe disease presentation as determined by the principal investigator\n* Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23\n* Understands and agrees to comply with planned study procedures\n* Available for clinical follow-up for duration of the treatment and follow-up period\n* Woman of childbearing potential must\n\n * Have a negative pregnancy test within 24 hours before starting treatment\n * Agree not to become pregnant during treatment and for 1 months after receiving remdesivir (Treatment will be a maximum of 10 doses given over a 10-day interval)\n * Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period\n\nExclusion Criteria:\n\n* ALT/AST ≥ 5 times the upper limit of normal\n* Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR \\<30)\n* Anticipated transfer to another hospital that is not a study site within 72 hours\n* Allergy to any components of the study medication \\[GS-5734, sulfobutylether β-cyclodextrin sodium (SBECD) and hydrochloric acid and/or sodium hydroxide\\]\n* Concomitant antiviral therapy (lopinavir/ritonavir \\[Kaletra\\])\n* Pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT04302766', 'briefTitle': 'Expanded Access Remdesivir (RDV; GS-5734™)', 'organization': {'class': 'FED', 'fullName': 'U.S. Army Medical Research and Development Command'}, 'officialTitle': 'Intermediate-Size Patient Population Expanded Access Treatment Protocol for Coronavirus Disease 2019 (COVID-19) Remdesivir (RDV; GS-5734™)', 'orgStudyIdInfo': {'id': 'S-20-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Remdesivir', 'type': 'DRUG', 'otherNames': ['GS-5734'], 'description': 'Remdesivir (RDV,GS-5734) is a monophosphoramidate prodrug of an adenosine analog with potent activity against an array of RNA virus families including Filoviridae, Paramyxoviridae, Pneumoviridae, and Orthocoronavirinae, through the targeting of the viral RNA dependent RNA polymerase (RdRp).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92134-5000', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Medical Center San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32214-5005', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Naval Hospital Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '31905', 'city': 'Fort Benning', 'state': 'Georgia', 'country': 'United States', 'facility': 'Benning Martin Army Community Hospital', 'geoPoint': {'lat': 32.35237, 'lon': -84.96882}}, {'zip': '30905-5741', 'city': 'Fort Gordon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Eisenhower Army Medical Center', 'geoPoint': {'lat': 33.42097, 'lon': -82.16206}}, {'zip': '96859-5000', 'city': 'Tripler AMC', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Tripler Army Medical Center'}, {'zip': '42223-5318', 'city': 'Fort Campbell North', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Blanchfield Army Community Hospital', 'geoPoint': {'lat': 36.65429, 'lon': -87.46056}}, {'zip': '20889-0001', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '28310-7324', 'city': 'Fort Bragg', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Womack Army Medical Center', 'geoPoint': {'lat': 35.139, 'lon': -79.00603}}, {'zip': '28547-2538', 'city': 'Marine Corps Base Camp Lejeune', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Naval Medical Center Camp Lejeune', 'geoPoint': {'lat': 34.58769, 'lon': -77.39259}}, {'zip': '79920-5001', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'William Beaumont Army Medical Center', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '76544-5095', 'city': 'Fort Hood', 'state': 'Texas', 'country': 'United States', 'facility': 'Carl R. Darnall Army Medical Center', 'geoPoint': {'lat': 31.25483, 'lon': -97.70913}}, {'zip': '78234-4504', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Brooke Army Medical Center', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}, {'zip': '23708-2197', 'city': 'Portsmouth', 'state': 'Virginia', 'country': 'United States', 'facility': 'Naval Medical Center Portsmouth', 'geoPoint': {'lat': 36.83543, 'lon': -76.29827}}, {'zip': '98431-0001', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Madigan Army Medical Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '09354', 'city': 'Bagrām', 'country': 'Afghanistan', 'facility': 'Craig Joint Theater Hospital', 'geoPoint': {'lat': 34.96694, 'lon': 69.265}}, {'city': 'Kandahar', 'country': 'Afghanistan', 'facility': 'NATO Role 3 Multinational Medical Unit Kandahar Air Field', 'geoPoint': {'lat': 31.61332, 'lon': 65.71013}}, {'city': 'Djibouti', 'country': 'Djibouti', 'facility': 'EMF Camp Lemonnier', 'geoPoint': {'lat': 11.58901, 'lon': 43.14503}}, {'zip': '09180', 'city': 'Landstuhl', 'state': 'APO AE', 'country': 'Germany', 'facility': 'Landstuhl Regional Medical Center', 'geoPoint': {'lat': 49.41306, 'lon': 7.57021}}, {'zip': '96910', 'city': 'Hagåtña', 'country': 'Guam', 'facility': 'US Naval Hospital Guam', 'geoPoint': {'lat': 13.47567, 'lon': 144.74886}}, {'zip': '09305', 'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Baghdad Diplomatic Support Center', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}, {'zip': '904-0103', 'city': 'Okinawa', 'country': 'Japan', 'facility': 'US Naval Hospital Okinawa', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'zip': '09366-9998', 'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'US Military Hospital Kuwait 411th Hospital Center', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'U.S. Army Medical Research and Development Command', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}