Study to assess the safety and effectiveness of remdesivir in people with moderate COVID-19
| ISRCTN | ISRCTN85762140 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85762140 |
| EudraCT/CTIS number | 2020-000842-32 |
| IRAS number | 282026 |
| ClinicalTrials.gov number | NCT04292730 |
| Secondary identifying numbers | GS-US-540-5774, IRAS 282026, CPMS 45459 |
- Submission date
- 02/11/2020
- Registration date
- 03/11/2020
- Last edited
- 30/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Background and study aims
The purpose of this study is to test a new medicine, remdesivir (RDV) for people with COVID-19.
There are no approved medications to treat COVID-19, a new disease caused by a virus called SARS-CoV-2 that was just identified in late 2019. COVID-19 can cause many symptoms. The symptoms can range from mild to very severe and sometimes can lead to death.
The purpose of this study is to see if RDV can improve the health of people with moderate COVID-19.
Who can participate?
Persons 12 years of age or older who have SARS-CoV-2 infection less than 4 days before joining the study, and are in hospital.
What does the study involve?
Part A was randomized and open-label (patients know what medication they are getting and for how long, doctors and study staff also know):
The researchers used a computer program to randomly choose the treatment each participant took. This helped make sure the treatments were chosen fairly. Participants had an equal chance of receiving RDV for 5 days, receiving RDV for 10 days or for not receiving RDV at all. In all treatment arms, participants still received standard of care treatment.
Part B was also open-label. Participants who qualified for the study and decided to join received RDV by injections directly into the vein. Participants were randomized to one of the following treatment groups:
1. Standard of care treatment together with RDV 200mg on Day 1 and then RDV 100mg on Days 2, 3, 4 and 5
2. Standard of care treatment together with RDV 200mg on Day 1 and then RDV 100mg on Days 2, 3, 4, 5, 6, 7, 8, 9 and 10
3. Standard of care treatment and no RDV
Part B Extension Treatment Group – For participants enrolled when Part A is completed, they received standard of care treatment together with RDV 200mg on Day 1 and then RDV 100mg on Days 2, 3, 4, 5, 6, 7, 8, 9, 10. The treatment may have been reduced to a total of 5 days based on the results from Part A.
What are the possible benefits and risks of participating?
Possible benefits: Participants may not get any benefit from taking part in this study. Studies are a way for doctors to see if a drug is useful in treating a disease. Taking part in this study may help us know more about how to treat people with COVID-19 in the future.
Possible risks: All medicines could potentially cause side effects in some people. Increases in levels of liver enzymes have been seen in some people who have taken RDV, which may be a sign of inflammation or damage to the cells in the liver.
Where is the study run from?
The study was run from Gilead Sciences, Inc. (USA) and took place at 133 centres globally.
When is the study starting and how long is it expected to run for?
February 2020 to June 2020
Who is funding the study?
Gilead Sciences, Inc. (USA)
Who is the main contact?
GileadClinicalTrials@gilead.com
Contact information
Ms Devi Sengupta
Scientific
Scientific
333 Lakeside Drive
Foster City
California
94404
United States of America
| Phone | +1 646-351-9642 |
|---|---|
| Devi.SenGupta@gilead.com |
Study information
| Study design | Phase 3 randomized open-label multi-center study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A phase 3 randomized study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with moderate COVID-19 compared to standard of care treatment |
| Study objectives | The odds of improvement for the RDV 5-day treatment group (Treatment Group 1) or 10-day treatment group (Treatment Group 2) is different from the odds of improvement for SOC treatment group (Treatment Group 3) with respect to clinical status assessed by a 7-point ordinal scale on Day 11. |
| Ethics approval(s) | Approved 25/03/2020, North East - Tyne & Wear South Research Ethics Committee (HRA Jarrow, Room 001, Jarrow Business Centre, Rolling Mill Road, Jarrow, NE32 3DT, UK; +44 (0)207 1048084; nrescommittee.northeast-tyneandwearsouth@nhs.net), ref: 20/NE/0105 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | The study was conducted in two parts. In Part A, approximately 600 participants who met all eligibility criteria were randomized via an interactive web response system (IWRS) in 1:1:1 ratio into one of the following treatment groups: Treatment Group 1: continued SOC therapy together with intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2, 3, 4, and 5 Treatment Group 2: continued SOC therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 Treatment Group 3: continued SOC therapy Part B began enrollment after enrollment to Part A is complete. In Part B, an additional approximately 1,000 participants who met all of the eligibility criteria received: Extension Treatment Group: continued standard of care therapy together with IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 Based on the results from Part A, or if treatment for 5 days is selected in a study of more severe disease, all participants in the Extension Treatment Group and all new participants will be reassigned to receive treatment for a total of 5 days. National and local regulatory authorities will be informed. All participants were followed-up for 28 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Remdesivir (RDV) |
| Primary outcome measure | The Odds of Ratio for Improvement on a 7-point Ordinal Scale (The ordinal scale is an assessment of the clinical status on a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol Remdesivir administration 7. Not hospitalized.) The ordinal scale was recorded each day from Baseline until discharge or Day14, any change in category from Day 14 to discharge (or Day28) was also recorded. |
| Secondary outcome measures | Adverse Events were recorded from patient medical records from the time of consent up to Day 28 (+/-5 days). Serious adverse events were reported up to 30 days of last dose and after the protocol defined follow-up period if deemed relevant to the use of study drug |
| Overall study start date | 11/02/2020 |
| Completion date | 26/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 12 Years |
| Sex | Both |
| Target number of participants | 1,600 |
| Total final enrolment | 1113 |
| Key inclusion criteria | 1. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under 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 2. Aged ≥18 years (at all sites), 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]) 3. SARS-CoV-2 infection confirmed by PCR test ≤4 days before randomization 4. Currently hospitalized and requiring medical care for COVID-19 5. SpO2 >94% on room air at screening 6. Radiographic evidence of pulmonary infiltrates 7. Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception |
| Key exclusion criteria | 1. Participation in any other clinical trial of an experimental treatment for COVID-19 2. Concurrent treatment or planned concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 3. Requiring mechanical ventilation at screening 4. ALT or AST >5 x ULN Note: if per local practice only ALT is routinely measured, exclusion criteria will be evaluated on ALT alone 5. Creatinine clearance <50 mL/min using the Cockcroft-Gault formula for participants ≥18 years of age and Schwartz Formula for participants <18 years of age 6. Positive pregnancy test 7. Breastfeeding woman 8. Known hypersensitivity to the study drug, the metabolites, or formulation excipient |
| Date of first enrolment | 15/03/2020 |
| Date of final enrolment | 29/05/2020 |
Locations
Countries of recruitment
- England
- France
- Germany
- Hong Kong
- Italy
- Japan
- Korea, South
- Netherlands
- Scotland
- Singapore
- Spain
- Sweden
- Switzerland
- Taiwan
- United Kingdom
- United States of America
Study participating centres
Princess Margaret Hospital
2-10 Princess Margaret Hospital Road
Kowloon
N.T.
Hong Kong
Kowloon
N.T.
Hong Kong
Nagoya City East Medical Center
1-2-23 Wakamizu,Chikusa-ku
Nagoya, Aichi
464-8547
Japan
Nagoya, Aichi
464-8547
Japan
Yokohama Municipal Citizen’s Hospital
1-1, Mitsuzawanishimachi, Kanagawa-ku
Yokohama-shi, Kanagawa
221-0855
Japan
Yokohama-shi, Kanagawa
221-0855
Japan
Seoul Medical Center
156 Sinnae-ro, Jungnang-gu
Seoul
2053
Korea, South
Seoul
2053
Korea, South
National Medical Center,
245, Euljiro, Jung-gu
Seoul
4564
Korea, South
Seoul
4564
Korea, South
National University Hospital
1E Kent Ridge Road
NUHS Tower Block
119228
Singapore
NUHS Tower Block
119228
Singapore
Singapore General Hospital (SGH)
20 College Road
169856
Singapore
169856
Singapore
National Centre for Infectious Diseases
16 Jalan Tan Tock Seng
308442
Singapore
308442
Singapore
Hôpital Saint-André
1 Rue Jean Burguet
Service des maladies infectieuses et tropicales
Bordeaux
33075
France
Service des maladies infectieuses et tropicales
Bordeaux
33075
France
Hôpital Saint Louis
1 Avenue Claude Vellefaux
Service des Maladies Infectieuses et Tropicales
Paris
75010
France
Service des Maladies Infectieuses et Tropicales
Paris
75010
France
Universitatsklinikum Dusseldorf
Moorenstraße 5
Düsseldorf
40225
Germany
Düsseldorf
40225
Germany
Klinikum St. Georg gGmbH
Delitzscher Strasse 141
Leipzig,Sachsen
4129
Germany
Leipzig,Sachsen
4129
Germany
Universitätsklinikum Hamburg Eppendorf
Martinistraße 52
I. Medizinische Klinik und Poliklinik, Hamburg
20246
Germany
I. Medizinische Klinik und Poliklinik, Hamburg
20246
Germany
Universitatsklinikum Schleswig-Holstein
Arnold Heller Straße 3
Klinik für Innere Medizin I
Kiel
24105
Germany
Klinik für Innere Medizin I
Kiel
24105
Germany
Charité - Universitätsmedizin Berlin
Augustenburger Platz 1
Berlin
13353
Germany
Berlin
13353
Germany
Klinikum rechts der Isar der Technischen Universität München
Ismaninger Str. 22
II. Medizinische Klinik und Poliklinik der TU München
München, Bayern
81675
Germany
II. Medizinische Klinik und Poliklinik der TU München
München, Bayern
81675
Germany
Klinikum Schwabing
Kölner Platz 1
München, Bayern
80804
Germany
München, Bayern
80804
Germany
Fondazione IRCCS Policlinico San Matteo di Pavia
Viale Golgi 19
UOC malattie Infettive I
Pavia
27100
Italy
UOC malattie Infettive I
Pavia
27100
Italy
Ospedale San Raffaele S.r.l. – PPDS
Via Olgettina 60
Isituto Scientifico Universitario San Raffaele
Milano
20132
Italy
Isituto Scientifico Universitario San Raffaele
Milano
20132
Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Pazzale Spedali Civili 1
U.O. di Malattie Infettive
Brescia
25123
Italy
U.O. di Malattie Infettive
Brescia
25123
Italy
Azienda Ospedaliera Di Padova
Via Giustiniani 2
Unità Operativa Malattie Infettive E Tropicali
Padova, Veneto
35128
Italy
Unità Operativa Malattie Infettive E Tropicali
Padova, Veneto
35128
Italy
Ospedale Guglielmo Da Saliceto
Via Taverna, 49
Piacenza, Emilia-Romagna
29100
Italy
Piacenza, Emilia-Romagna
29100
Italy
Comprensorio Amedeo Di Savoia Birago Di Vische
Corso Svizzera 164
Torino, Piemonte
10149
Italy
Torino, Piemonte
10149
Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Via Giovanni Battista Grassi, 74
Dipartimento di Scienze Biomediche e Cliniche L. Sacco
Milano, Lombardia
20157
Italy
Dipartimento di Scienze Biomediche e Cliniche L. Sacco
Milano, Lombardia
20157
Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Via Francesco Sforza 35,Milano
Lombardia
20122
Italy
Lombardia
20122
Italy
Azienda Ospedaliero Universitaria di Parma
Via Gramsci 14
Parma
43100
Italy
Parma
43100
Italy
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Via Portuense 292
Roma
00149
Italy
Roma
00149
Italy
ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
Viale Concordia 1
Cremona, Lombardia
26100
Italy
Cremona, Lombardia
26100
Italy
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
Piazza OMS 1, Bergamo
24127
Italy
24127
Italy
Academisch Medisch Centrum Amsterdam
Meibergdreef 9
Amsterdam, Noord-Holland
1105 AZ
Netherlands
Amsterdam, Noord-Holland
1105 AZ
Netherlands
Leids Universitair Medisch Centrum
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Leiden
2333 ZA
Netherlands
Hospital Universitario A Coruña
As Xubias, 84, A Coruña
15006
Spain
15006
Spain
Hospital Universitario La Paz – PPDS
Paseo de la Castellana 261, Madrid
28046
Spain
28046
Spain
Hospital Universitario de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
8907
Spain
L'Hospitalet de Llobregat
Barcelona
8907
Spain
Hospital Regional Universitario de Malaga – Hospital General
Avda. Carlos Haya, s/n
Servicio de Enfermedades Infecciosas
Pabellon A, 2ª planta
Malaga
29010
Spain
Servicio de Enfermedades Infecciosas
Pabellon A, 2ª planta
Malaga
29010
Spain
Hospital Universitari i Politecnic La Fe de Valencia
Avenida Fernado Abril Martorell, 106
Valencia
46026
Spain
Valencia
46026
Spain
Hospital Universitario Virgen del Rocio – PPDS
Avenida Manuel Siurot s/n
Sevilla
41013
Spain
Sevilla
41013
Spain
Hospital Universitario de Cruces, Cruces Plaza
S/N
Unidad enfermedades infecciosas, Barakaldo
48903
Spain
Unidad enfermedades infecciosas, Barakaldo
48903
Spain
Hospital Universitario Fundacion Jimenez Diaz
Av. Reyes Católicos 2
Madrid
28040
Spain
Madrid
28040
Spain
Hospital Universitario 12 de Octubre
Avenida de Andalucía s/n, Madrid
28041
Spain
28041
Spain
Hospital Universitario Ramon y Cajal
Ctra. de Colmenar, Km. 9,100
Madrid
28034
Spain
Madrid
28034
Spain
Hospital Universitario Principe de Asturias
Carretera de Alcala Meco s/n
Madrid
28805
Spain
Madrid
28805
Spain
Hospital Clinic de Barcelona
C/ Villarroel 170
Badalona, Barcelona
8036
Spain
Badalona, Barcelona
8036
Spain
Karolinska University Hospital
Hälsovägen, Stockholm
SE-141 86
Sweden
SE-141 86
Sweden
Skånes Universitetssjukhus Malmö
Ruth Lundskogs gata 3
Infektionskliniken
Malmö
SE-20502
Sweden
Infektionskliniken
Malmö
SE-20502
Sweden
Ospedale Regionale Lugano Civico
Via Tesserete 46, Lugano
Ticino (it)
6900
Switzerland
Ticino (it)
6900
Switzerland
Hopitaux Universitaires de Geneve (HUG)
4 Rue Gabrielle Perret-Gentil
Geneve
1205
Switzerland
Geneve
1205
Switzerland
Universitätsspital Zürich,
Rämistrasse 100
Klinik für Infektiologie und Spitalhygiene
Zürich, Zürich (de)
8091
Switzerland
Klinik für Infektiologie und Spitalhygiene
Zürich, Zürich (de)
8091
Switzerland
Royal Free London NHS Foundation Trust
Hampstead
London
NW3 5NU
United Kingdom
London
NW3 5NU
United Kingdom
University College London Hospitals (UCLH)
235 Euston Road
London
NW1 2BU
United Kingdom
London
NW1 2BU
United Kingdom
St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom
London
W2 1NY
United Kingdom
Derriford Hospital
Derriford Road
Crownhill
Plymouth
PL6 8DH
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
Sheffield
S10 2JF
United Kingdom
Royal Infirmary of Edinburgh – PPDS
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Edinburgh
EH16 4SA
United Kingdom
Queen Elizabeth University Hospital – PPDS
1345 Govan Road
Glasgow
G51 4TF
United Kingdom
Glasgow
G51 4TF
United Kingdom
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
Cottingham
HU16 5JQ
United Kingdom
King's College Hospital
King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
United Kingdom
Denmark Hill
London
SE5 9RS
United Kingdom
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
Liverpool
L7 8XP
United Kingdom
North Manchester General Hospital
Delaunays Road
Crumpsall
Manchester
M8 5RB
United Kingdom
Crumpsall
Manchester
M8 5RB
United Kingdom
Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
Harrow
London
HA1 3UJ
United Kingdom
Icahn School of Medicine at Mount Sinai
17 East 102nd Street, 8th Floor
New York
10029
United States of America
New York
10029
United States of America
Mount Sinai West
1000 10th Avenue, Suite 2T, New York, NY
10019
United States of America
10019
United States of America
Mount Sinai Beth Israel
350 East 17th Street, 3rd floor, New York, NY
1003
United States of America
1003
United States of America
St Joseph Hospital – Eureka
2700 Dolbeer Street
Eureka, California
95501
United States of America
Eureka, California
95501
United States of America
Kadlec Regional Medical Center
45 Goethals Drive
Suite 300
Richland, Washington
99352
United States of America
Suite 300
Richland, Washington
99352
United States of America
Mission Hospital
27700 Medical Center Road
Mission Viejo
California
92691
United States of America
Mission Viejo
California
92691
United States of America
Hennepin Healthcare Research Institute
701 Park Avenue
Minneapolis, Minnesota
55415
United States of America
Minneapolis, Minnesota
55415
United States of America
Hackensack University Medical Center
30 Prospect Avenue
Hackensack, New Jersey
7601
United States of America
Hackensack, New Jersey
7601
United States of America
Henry Ford Hospital
2799 West Grand Blvd
Detroit, Michigan
48202
United States of America
Detroit, Michigan
48202
United States of America
James J Peters Veterans Administration Medical Center – NAVREF
130 West Kingsbridge Road
Bronx, New York
10468
United States of America
Bronx, New York
10468
United States of America
St.Joseph Hospital – Orange
1100 West Stewart Drive
Orange, California
92868
United States of America
Orange, California
92868
United States of America
University of Colorado
4200 East 9th Avenue
Denver, Colorado
80262
United States of America
Denver, Colorado
80262
United States of America
MultiCare Institute for Research and Innovation
910 West 5th Ave.
Suite 1001, Spokane
Washington
99204
United States of America
Suite 1001, Spokane
Washington
99204
United States of America
Temple University Hospital
1801 N. Broad Street
Philadelphia, Pennsylvania
19122
United States of America
Philadelphia, Pennsylvania
19122
United States of America
Hospital of the University of Pennsylvania
3400 Spruce Street
Philadelphia, Pennsylvania
19104
United States of America
Philadelphia, Pennsylvania
19104
United States of America
Providence Regional Medical Center Everett
1330 Rockefeller Avenue
Suite 440, Everett
Washington
98201
United States of America
Suite 440, Everett
Washington
98201
United States of America
Tulane University School of Medicine
1415 Tulane Avenue
New Orleans
Louisiana
70112
United States of America
New Orleans
Louisiana
70112
United States of America
Swedish Medical Center
747 Broadway
Seattle, Washington
98122
United States of America
Seattle, Washington
98122
United States of America
Baylor University Medical Center
3500 Gaston Ave
Dallas, Texas
75246
United States of America
Dallas, Texas
75246
United States of America
Saints Medical Center
1400 8th Ave
Fort Worth, TX
76104
United States of America
Fort Worth, TX
76104
United States of America
Baylor Scott & White Medical Center -Temple
2401 S 31st St
Temple, TX
76508
United States of America
Temple, TX
76508
United States of America
Sutter Santa Rosa Regional Hospital
30 Mark West Springs Rd
Santa Rosa, California
95403
United States of America
Santa Rosa, California
95403
United States of America
Houston Methodist Hospital
6565 Fannin Street
TX Medical Flagship
Houston, Texas
77030
United States of America
TX Medical Flagship
Houston, Texas
77030
United States of America
Indiana University School of Medicine-Indianapolis
545 Barnhill Drive
Emerson Hall
Suite 421, Indianapolis
Indiana
46077
United States of America
Emerson Hall
Suite 421, Indianapolis
Indiana
46077
United States of America
Rose Medical Center
4567 East 9th Avenue
Denver, Colorado
80220
United States of America
Denver, Colorado
80220
United States of America
Providence St. John’s Health Center
2121 Santa Monica Blvd
1st Floor, Santa Monica
90404
United States of America
1st Floor, Santa Monica
90404
United States of America
Prisma Health–Midlands
5 Richland ,Medical Park Drive
Columbia, South Carolina
29203
United States of America
Columbia, South Carolina
29203
United States of America
Prisma Health-Greenville Memorial Hospital
701 Grove Rd
Greenville, SC
29605
United States of America
Greenville, SC
29605
United States of America
University Hospitals Cleveland Medical Center
11100 Euclid Ave
Cleveland, Ohio
44106
United States of America
Cleveland, Ohio
44106
United States of America
John H. Stroger, Jr. Hospital of Cook County
1901 West Harrison Street
Chicago, Illinois
60612
United States of America
Chicago, Illinois
60612
United States of America
University Of Iowa Hospitals And Clinics
200 Hawkins Drive
Iowa City, Iowa
52242
United States of America
Iowa City, Iowa
52242
United States of America
UT Southwestern Medical Center–ID Clinical Reseach
1936 Amelia Court
2nd Floor
Dallas, TX
75235
United States of America
2nd Floor
Dallas, TX
75235
United States of America
Holy Cross Hospital
1500 Forest Glen Road
Silver Spring, Maryland
20910
United States of America
Silver Spring, Maryland
20910
United States of America
University of Michigan
1500 East Medical Center Drive
Ann Arbor, Michigan
48109
United States of America
Ann Arbor, Michigan
48109
United States of America
Inova Fairfax Hospital
3300 Gallows Road
Falls Church, Virginia
22042
United States of America
Falls Church, Virginia
22042
United States of America
Sutter Medical Center Sacramento
2825 Capitol Avenue
Sacramento, California
95816
United States of America
Sacramento, California
95816
United States of America
Jacobi Medical Center
1400 Pelham Parkway South
Bronx, New York
10461
United States of America
Bronx, New York
10461
United States of America
California Pacific Medical Center
1101 Van Ness Avenue
San Francisco, California
94109
United States of America
San Francisco, California
94109
United States of America
Northwell Health
300 Community Drive
Manhasset, New York
11030
United States of America
Manhasset, New York
11030
United States of America
Long Island Jewish Medical Center
270-05 76th Aven
New Hyde Park, NY
11040
United States of America
New Hyde Park, NY
11040
United States of America
Virginia Mason Medical Center
1100 9th Avenue
Seattle, Washington
98101
United States of America
Seattle, Washington
98101
United States of America
Tacoma General Hospital
315 Martin Luther King Jr Way
Tacoma, Washington
98405
United States of America
Tacoma, Washington
98405
United States of America
Liver Institute at Methodist Dallas
1411 North Beckley Avenue
Pavillion III
Suite 268, Dallas, Texas
75203
United States of America
Pavillion III
Suite 268, Dallas, Texas
75203
United States of America
Weill Cornell Medicine
1300 York Avenue
New York
10065
United States of America
New York
10065
United States of America
Brigham and Womens Hospital
75 Francis Street
Division of Infectious Disease
Brigham and Women's Hospital
Boston, Massachusetts
2115
United States of America
Division of Infectious Disease
Brigham and Women's Hospital
Boston, Massachusetts
2115
United States of America
Alta Bates Summit Medical Center
2450 Ashby Avenue
Berkeley, California
94705
United States of America
Berkeley, California
94705
United States of America
Virginia Hospital Center
1701 North George Mason Drive, Arlington, Virginia
2205
United States of America
2205
United States of America
Kaiser Permanente Center For Health Research
3800 North Interstate Avenue
Portland, Oregon
97227
United States of America
Portland, Oregon
97227
United States of America
University of Chicago
5801 S. Ellia Avenue
Chicago, Illinois
60637
United States of America
Chicago, Illinois
60637
United States of America
Robert Wood Johnson University Hospital New Brunswick
1 RWJ Place
New Brunswick, NJ
08901
United States of America
New Brunswick, NJ
08901
United States of America
Danbury Hospital
24 Hospital Avenue
Danbury, Connecticut
6810
United States of America
Danbury, Connecticut
6810
United States of America
Columbia University Medical Center
177 Fort Washington Avenue
Milstein Hospital
Fourth Floor, New York
10032
United States of America
Milstein Hospital
Fourth Floor, New York
10032
United States of America
Yale-New Haven Hospital
20 York St
New Haven, Connecticut
06510-3220
United States of America
New Haven, Connecticut
06510-3220
United States of America
Tufts Medical Center – PPDS
800 Washington Street
Boston, Massachusetts
2111
United States of America
Boston, Massachusetts
2111
United States of America
Providence Saint Vincent's Medical Center
9205 Southwest Barnes Road
Portland, Oregon
97225
United States of America
Portland, Oregon
97225
United States of America
St Joseph's Regional Medical Center
703 Main Street
Paterson, New Jersey
7503
United States of America
Paterson, New Jersey
7503
United States of America
Mayo Clinic – PPDS
200 First Street Southwest
Rochester, Minnesota
55905
United States of America
Rochester, Minnesota
55905
United States of America
Hoag Memorial Hospital Presbyterian
One Hoag Drive
Newport Beach, California
92663
United States of America
Newport Beach, California
92663
United States of America
Virginia Commonwealth University
1250 East Marshall Street
Richmond, Virginia
23298
United States of America
Richmond, Virginia
23298
United States of America
Maine Medical Center
22 Bramhall Street
Portland, Maine
4102
United States of America
Portland, Maine
4102
United States of America
Rush University Medical Center
600 South Paulina
Suite 143, Chicago, Illinois
60612
United States of America
Suite 143, Chicago, Illinois
60612
United States of America
El Camino Hospital
2500 Grant Road
Mountain View, California
94040
United States of America
Mountain View, California
94040
United States of America
Kaiser Permanente Oakland Medical Center
3600 Broadway
Oakland, California
94611
United States of America
Oakland, California
94611
United States of America
Kaiser Permanente San Francisco Medical Center
2425 Geary Blvd. San Francisco, CA
94115
United States of America
94115
United States of America
Kaiser Permanente Santa Clara
700 Lawrence Expressway, Santa Clara, CA
95051
United States of America
95051
United States of America
Kaiser Permanente San Jose
Medical Center – 250 Hospital Parkway, San Jose, CA
95119
United States of America
95119
United States of America
Kaiser Permanente South San Francisco Medical Center
1200 El Camino Real, San Francisco, CA
94080
United States of America
94080
United States of America
Beth Israel Deaconess Medical Center
330 Brookline Avenue
Boston, Massachusetts
2215
United States of America
Boston, Massachusetts
2215
United States of America
Stanford University School of Medicine
300 Pasteur Drive
Stanford, California
94305
United States of America
Stanford, California
94305
United States of America
Miriam Hospital
164 Summitt Avenue
Providence, Rhode Island
2906
United States of America
Providence, Rhode Island
2906
United States of America
Duke University Medical Center
2301 Erwin Road
Durham, North Carolina
27710
United States of America
Durham, North Carolina
27710
United States of America
Dartmouth-Hitchcock Medical Center
1 Medical Center Drive
Lebanon, New Hampshire
3766
United States of America
Lebanon, New Hampshire
3766
United States of America
Sponsor information
Gilead Sciences (United States)
Industry
Industry
333 Lakeside Drive
Foster City
California
94404
United States of America
| Phone | +1-833-445-3230 |
|---|---|
| GileadClinicalTrials@gilead.com | |
| Website | http://www.gilead.com/ |
"ROR" |
https://ror.org/056546b03 |
Funders
Funder type
Industry
Gilead Sciences
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Gilead, Gilead Sciences, Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. A redacted version of the latest protocol and statistical analysis plan, will be available on ClinicalTrials.gov when results are submitted https://clinicaltrials.gov/ct2/show/NCT04292730) |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Gilead Sciences shares anonymized individual patient data upon request or as required by law or regulation with qualified external researchers based on submitted curriculum vitae and reflecting non conflict of interest. The request proposal must also include a statistician. Approval of such requests is at Gilead Science’s discretion and is dependent on the nature of the request, the merit of the research proposed, the availability of the data, and the intended use of the data. Data requests should be sent to datarequest@gilead.com . Data will become available 18 months after study completion and will be accessible in a secured external environment. More information on Gilead’s data sharing policy can be found here: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy . |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | 15/09/2020 | 25/03/2021 | Yes | No | |
| Protocol (other) | V2.0 | 29/04/2020 | 30/11/2022 | No | No |
| Statistical Analysis Plan | v1.0 | 26/06/2020 | 30/11/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
30/11/2022: Protocol and statistical analysis plan added.
25/03/2021: The following changes have been made:
1. Publication reference added.
2. A basic results link has been added.
03/11/2020: Trial’s existence confirmed by North East - Tyne & Wear South Research Ethics Committee.
