Studies
| Study First Submitted Date | 2020-03-02 |
| Study First Posted Date | 2020-03-10 |
| Last Update Posted Date | 2022-02-17 |
| Verification Month Year | February 2022 |
| Verification Date | 2022-02-28 |
| Last Update Posted Date | 2022-02-17 |
Detailed Descriptions
| Sequence: | 20759055 |
| Description | 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) |
Facilities
| Sequence: | 200423860 | Sequence: | 200423861 | Sequence: | 200423862 | Sequence: | 200423863 | Sequence: | 200423864 | Sequence: | 200423865 | Sequence: | 200423866 | Sequence: | 200423867 | Sequence: | 200423868 | Sequence: | 200423869 | Sequence: | 200423870 | Sequence: | 200423871 | Sequence: | 200423872 | Sequence: | 200423873 | Sequence: | 200423874 | Sequence: | 200423875 | Sequence: | 200423876 | Sequence: | 200423877 | Sequence: | 200423878 | Sequence: | 200423879 | Sequence: | 200423880 | Sequence: | 200423881 |
| Name | Naval Medical Center San Diego | Name | Naval Hospital Jacksonville | Name | Benning Martin Army Community Hospital | Name | Eisenhower Army Medical Center | Name | Tripler Army Medical Center | Name | Blanchfield Army Community Hospital | Name | Walter Reed National Military Medical Center | Name | Naval Medical Center Camp Lejeune | Name | Womack Army Medical Center | Name | William Beaumont Army Medical Center | Name | Carl R. Darnall Army Medical Center | Name | Brooke Army Medical Center | Name | Naval Medical Center Portsmouth | Name | Madigan Army Medical Center | Name | Craig Joint Theater Hospital | Name | NATO Role 3 Multinational Medical Unit Kandahar Air Field | Name | EMF Camp Lemonnier | Name | Landstuhl Regional Medical Center | Name | US Naval Hospital Guam | Name | Baghdad Diplomatic Support Center | Name | US Naval Hospital Okinawa | Name | US Military Hospital Kuwait 411th Hospital Center |
| City | San Diego | City | Jacksonville | City | Fort Benning | City | Fort Gordon | City | Tripler AMC | City | Fort Campbell North | City | Bethesda | City | Camp Lejeune | City | Fort Bragg | City | El Paso | City | Fort Hood | City | Fort Sam Houston | City | Portsmouth | City | Tacoma | City | Bagrām | City | Kandahar | City | Djibouti | City | Landstuhl | City | Agaña | City | Baghdad | City | Okinawa | City | Kuwait |
| State | California | State | Florida | State | Georgia | State | Georgia | State | Hawaii | State | Kentucky | State | Maryland | State | North Carolina | State | North Carolina | State | Texas | State | Texas | State | Texas | State | Virginia | State | Washington | State | APO Ae | ||||||||||||||
| Zip | 92134-5000 | Zip | 32214-5005 | Zip | 31905 | Zip | 30905-5741 | Zip | 96859-5000 | Zip | 42223-5318 | Zip | 20889-0001 | Zip | 28547-2538 | Zip | 28310-7324 | Zip | 79920-5001 | Zip | 76544-5095 | Zip | 78234-4504 | Zip | 23708-2197 | Zip | 98431-0001 | Zip | 09354 | Zip | 09180 | Zip | 96910 | Zip | 09305 | Zip | 904-0103 | Zip | 09366-9998 | ||||
| Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | Afghanistan | Country | Afghanistan | Country | Djibouti | Country | Germany | Country | Guam | Country | Iraq | Country | Japan | Country | Kuwait |
Browse Interventions
| Sequence: | 96205231 | Sequence: | 96205232 | Sequence: | 96205233 | Sequence: | 96205234 | Sequence: | 96205235 |
| Mesh Term | Remdesivir | Mesh Term | Antimetabolites | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antiviral Agents | Mesh Term | Anti-Infective Agents |
| Downcase Mesh Term | remdesivir | Downcase Mesh Term | antimetabolites | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antiviral agents | Downcase Mesh Term | anti-infective agents |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52267332 |
| Name | Coronavirus Disease 2019 |
| Downcase Name | coronavirus disease 2019 |
Id Information
| Sequence: | 40228412 |
| Id Source | org_study_id |
| Id Value | S-20-01 |
Countries
| Sequence: | 42644999 | Sequence: | 42645000 | Sequence: | 42645001 | Sequence: | 42645002 | Sequence: | 42645003 | Sequence: | 42645004 | Sequence: | 42645005 | Sequence: | 42645006 |
| Name | United States | Name | Afghanistan | Name | Djibouti | Name | Germany | Name | Guam | Name | Iraq | Name | Japan | Name | Kuwait |
| Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False | Removed | False |
Interventions
| Sequence: | 52579897 |
| Intervention Type | Drug |
| Name | Remdesivir |
| 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). |
Keywords
| Sequence: | 80005371 | Sequence: | 80005372 | Sequence: | 80005373 | Sequence: | 80005374 |
| Name | COVID-19 | Name | GS-5734 | Name | Remdesivir | Name | SARS-CoV-2 |
| Downcase Name | covid-19 | Downcase Name | gs-5734 | Downcase Name | remdesivir | Downcase Name | sars-cov-2 |
Browse Conditions
| Sequence: | 193854066 | Sequence: | 193854065 | Sequence: | 193854067 | Sequence: | 193854068 | Sequence: | 193854069 | Sequence: | 193854070 | Sequence: | 193854071 | Sequence: | 193854072 | Sequence: | 193854073 | Sequence: | 193854074 | Sequence: | 193854075 | Sequence: | 193854076 |
| Mesh Term | COVID-19 | Mesh Term | Coronavirus Infections | Mesh Term | Coronaviridae Infections | Mesh Term | Nidovirales Infections | Mesh Term | RNA Virus Infections | Mesh Term | Virus Diseases | Mesh Term | Infections | Mesh Term | Pneumonia, Viral | Mesh Term | Pneumonia | Mesh Term | Respiratory Tract Infections | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases |
| Downcase Mesh Term | covid-19 | Downcase Mesh Term | coronavirus infections | Downcase Mesh Term | coronaviridae infections | Downcase Mesh Term | nidovirales infections | Downcase Mesh Term | rna virus infections | Downcase Mesh Term | virus diseases | Downcase Mesh Term | infections | Downcase Mesh Term | pneumonia, viral | Downcase Mesh Term | pneumonia | Downcase Mesh Term | respiratory tract infections | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48409019 |
| Agency Class | FED |
| Lead Or Collaborator | lead |
| Name | U.S. Army Medical Research and Development Command |
Eligibilities
| Sequence: | 30821218 |
| Gender | All |
| Minimum Age | N/A |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria: 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 Have a laboratory-confirmed COVID-19 diagnosis with moderate to severe disease presentation as determined by the principal investigator Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23 Understands and agrees to comply with planned study procedures Available for clinical follow-up for duration of the treatment and follow-up period Woman of childbearing potential must Have a negative pregnancy test within 24 hours before starting treatment 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) Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period Exclusion Criteria: ALT/AST ≥ 5 times the upper limit of normal Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR <30) Anticipated transfer to another hospital that is not a study site within 72 hours Allergy to any components of the study medication [GS-5734, sulfobutylether β-cyclodextrin sodium (SBECD) and hydrochloric acid and/or sodium hydroxide] Concomitant antiviral therapy (lopinavir/ritonavir [Kaletra]) Pregnant or nursing |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254109091 |
| Number Of Facilities | 22 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
Intervention Other Names
| Sequence: | 26718381 |
| Intervention Id | 52579897 |
| Name | GS-5734 |
Provided Documents
| Sequence: | 2588480 |
| Document Type | Informed Consent Form |
| Has Protocol | False |
| Has Icf | True |
| Has Sap | False |
| Document Date | 2020-06-23 |
| Url | https://ClinicalTrials.gov/ProvidedDocs/66/NCT04302766/ICF_000.pdf |
Responsible Parties
| Sequence: | 28933559 |
| Responsible Party Type | Sponsor |