Clinical trial NCT04518410: ACTIV-2: A Study for Outpatients With COVID-19
Official title: Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronavirus
Covid19
Keywords: COVID-19
Coronavirus
COVID 19
Coronaviridae Infections
Coronavirus Infections
RNA Virus Infections
Virus Diseases
Nidovirales Infections
SARS-CoV-2
SARS Coronavirus
ACTIV-2
ACTIV2
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Eli Lilly and Company
name: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
name: Brii Biosciences Limited
name: AstraZeneca
name: Sagent Pharmaceuticals
name: Synairgen Research Ltd.
name: Bristol-Myers Squibb
name: SAb Biotherapeutics, Inc.
First posted: 2020-08-19
Enrollment: 4044
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community.

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.

Detailed description: This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression.

The study includes both infused and non-infused agents and is a randomized controlled platform that allows agents to be added and dropped during the course of the study for efficient phase II and phase III testing of new agents within the same trial infrastructure.

Version 7 of the protocol provided for blinded phase II evaluation of an investigational agent for superiority to placebo among participants at lower risk of progression to hospitalization or death, regardless of the mode of administration of the agent.

Agents that graduate to phase III after initiation of the protocol version will be evaluated in persons at higher risk for progression to hospitalization or death for non-inferiority to an active comparator (monoclonal antibody cocktail of casirivimab plus imdevimab (REGEN-COV, Regeneron). This active comparator has been shown to be effective in this population in preventing hospitalization or death. When two or more agents are being evaluated in the same phase of the study, the trial design includes sharing of the control group (placebo in phase II and active comparator in phase III) for efficient evaluation of each agent.

Investigational agents will be approved by the Trial Oversight Committee (TOC) for phase II evaluation based on the presence of in vitro data demonstrating promise as anti-SARS-CoV-2 therapeutics in pre-clinical testing, and for which there are suitable pharmacokinetics and safety data from phase I testing, or through clinical or research testing for a different indication, and agent availability. Investigational agents will be included in phase III evaluation based on agent entry criteria for phase III as outlined in the protocol (or by TOC approval based on data available outside ACTIV-2).

Eligibility criteria: Inclusion Criteria:

* Signed informed consent.
* Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry. Laboratory-confirmed SARS-CoV-2 infection outside the US must be conducted at a DAIDS-approved laboratory.
* Able to begin study treatment no later than 7 days from self-reported onset of COVID-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list:

  * subjective fever or feeling feverish
  * cough
  * shortness of breath or difficulty breathing at rest or with activity
  * sore throat
  * body pain or muscle pain/aches
  * fatigue
  * headache
  * chills
  * nasal obstruction or congestion
  * nasal discharge
  * loss of taste or smell
  * nausea or vomiting
  * diarrhea
  * temperature \> 38°C (100.4°F)
* One or more of the following signs/symptoms within 24 hours of participating in the study:

  * subjective fever or feeling feverish
  * cough
  * shortness of breath or difficulty breathing at rest or with activity
  * sore throat
  * body pain or muscle pain/aches
  * fatigue
  * headache
  * chills
  * nasal obstruction or congestion
  * nasal discharge
  * loss of taste or smell
  * nausea or vomiting
  * diarrhea
  * temperature \> 38°C (100.4°F)
* Oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level.
* Participant must agree not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first.
* Meet the protocol definition of being at "higher" risk of progression to hospitalization or death (BRII-196/BRII-198).
* In Phase III, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (SNG001, SAB-185, BMS 986414+BMS 986413)
* For participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a CLIA certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Note: Participants not of reproductive potential are eligible without requiring the use of a contraceptive method (BRII-196/BRII-198. AZD7442 \[IV\], AZD7442 \[IM\], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
* Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. Participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. Participants should refrain from sperm donation for 24 weeks after investigational agent administration (BRII-196/BRII-198, AZD7442 \[IV\], AZD7442 \[IM\], SAB-185).
* Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. Participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. Participants should refrain from sperm donation for 30 days after investigational agent administration (SNG001).
* Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. Participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. Participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (Camostat).
* If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. This would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods.
* If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (AZD7442 \[IV\], AZD7442 \[IM\], SAB-185).
* If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (SNG001).
* If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (Camostat).
* If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (BMS 986414+BMS 986413).

Exclusion Criteria:

* History of or current hospitalization for COVID-19.
* For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen tests from any respiratory tract specimen collected \> 240 hours prior to study entry.
* Current need for hospitalization or immediate medical attention.
* Use of any prohibited medication listed in the protocol and/or use of systemic or inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from chronic baseline) within 30 days prior to study.
* Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry.
* Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases or COVID-19 vaccines).
* Known allergy/sensitivity or hypersensitivity to study drug or placebo.
* Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study.
* Currently pregnant or breastfeeding (BRII-196/BRII-198, AZD7442 \[IV\], AZD7442 \[IM\], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
* In phase II, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (AZD7442 \[IV\], AZD7442 \[IM\], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
* Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, or other overlying skin conditions or tattoos that would preclude the assessment of injection site reactions, per the discretion of the investigator (AZD7442 \[IM\]).
* Inflammatory skin conditions that compromise the safety of subcutaneous (SC) injections, or other overlying skin conditions or tattoos that would preclude the assessment of infection site reactions, per the discretion of the investigator (BMS 986414+BMS 986413).
* History of coagulopathy which, in the opinion of the investigator, would preclude IM injection, or use of oral or injectable anticoagulants (protocol provides more information on prohibited medications) (AZD7442 \[IM\]).
* Use of or need for chronic supplemental oxygen (SNG001).
* Known severe liver disease prior to enrollment (defined as ALT or AST \> 5 times upper limit of normal or end stage liver disease with Child-Pugh Class C or Child-Pugh-Turcotte score ≥ 10) (Camostat).
* Known severe kidney disease prior to enrollment (defined as estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m² or on renal-replacement therapy such as peritoneal dialysis or hemodialysis (Camostat)

Other investigational drug protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: COVID-19 Symptom Duration (Phase 2)
timeFrame: Up to Day 28
measure: Quantification of SARS-CoV-2 RNA (Phase 2)
timeFrame: Day 3
measure: Quantification of SARS-CoV-2 RNA (Phase 2)
timeFrame: Day 7
measure: Quantification of SARS-CoV-2 RNA (Phase 2)
timeFrame: Day 14
measure: Number of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2)
timeFrame: Thru Day 28
measure: Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3)
timeFrame: Thru Day 28
measure: Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3)
timeFrame: Thru Day 28
Secondary outcomes:
measure: COVID-19 Symptom Duration (Phase 3)
timeFrame: Thru Day 28
measure: Quantification of SARS-CoV-2 RNA (Phase 3)
timeFrame: Day 3
measure: Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2)
timeFrame: Thru Day 28
measure: Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3)
timeFrame: Thru Day 28
measure: Level of SARS-CoV-2 RNA From NP Swabs (Phase 2)
timeFrame: Thru Day 14
measure: Level of SARS-CoV-2 RNA From NP Swabs (Phase 3)
timeFrame: Day 3
measure: Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3)
timeFrame: Thru Day 28
measure: COVID-19 Symptom Severity Ranking (Phases 2 and 3)
timeFrame: From Day 0 thru Day 28
measure: Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3)
timeFrame: Thru Day 28
measure: Time to Self-reported Return to Usual Health (a) (Phases 2 and 3)
timeFrame: Thru Day 28
measure: Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
timeFrame: Day 0 thru Week 24
measure: Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
timeFrame: Day 0 thru Week 72
measure: Oxygen Saturation Level (Phases 2 and 3)
timeFrame: Thru Day 28
measure: AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2)
timeFrame: Thru Day 14
measure: Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
timeFrame: Thru Day 28
measure: Proportion of Participants With New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
timeFrame: Thru Week 24
measure: Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3)
timeFrame: Thru Week 24
measure: Time to Self-reported Return to Usual Health (b) (Phases 2 and 3)
timeFrame: Thru Day 28
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group (Site 1082), 321 E. 10th Street
state: Alabama
city: Athens
country: United States
facility: North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (Site 1005), 908 20th Street South
state: Alabama
city: Cullman
country: United States
facility: Cullman Clinical Trials (Site 1140), 501 Clark St. NE.
state: Alabama
city: Jasper
country: United States
facility: Jasper Summit Research, LLC. (Site 1056), 1280 Summit
state: Alabama
city: Phoenix
country: United States
facility: Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211
state: Arizona
city: Tucson
country: United States
facility: University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410
state: Arizona
city: Anaheim
country: United States
facility: Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I
state: California
city: Bakersfield
country: United States
facility: Franco A. Felizarta MD (Site 1174), 3535 San Dimas St.
state: California
city: Canyon Country
country: United States
facility: Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd.
state: California
city: La Jolla
country: United States
facility: University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer
state: California
city: La Mesa
country: United States
facility: Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320
state: California
city: La Palma
country: United States
facility: Atella Clinical Research (Site 1111), 5451 La Palma Avenue
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C
state: California
city: Los Angeles
country: United States
facility: University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100
state: California
city: Los Angeles
country: United States
facility: Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100
state: California
city: Mather
country: United States
facility: VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way
state: California
city: Modesto
country: United States
facility: Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr.
state: California
city: Northridge
country: United States
facility: Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210
state: California
city: Orange
country: United States
facility: University of California Irvine (Site 1083), 843 Health Sciences Road
state: California
city: Oxnard
country: United States
facility: FOMAT Medical Research (Site 1136), 300 South A Street
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive
state: California
city: Redding
country: United States
facility: Paradigm Research (Site 1150), 3652 Eureka Way
state: California
city: Riverside
country: United States
facility: Riverside Medical Clinic (Site 1232), 7117 Brockton Ave.
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd.
state: California
city: San Bernardino
country: United States
facility: Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave.
state: California
city: San Diego
country: United States
facility: University of California San Diego (Site 1002), 220 Dickinson Street
state: California
city: San Diego
country: United States
facility: Zion Medical Center (Site 1063), 4647 Zion Avenue
state: California
city: San Diego
country: United States
facility: VA San Diego Health System (Stie 1127), 3350 La Jolla
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84
state: California
city: San Francisco
country: United States
facility: San Francisco Research Institute (Site 1210), 2435 Ocean Ave.
state: California
city: Stanford
country: United States
facility: Stanford University (Site 1213), 1201 Welch Road
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208
state: California
city: Thousand Oaks
country: United States
facility: Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301
state: California
city: Torrance
country: United States
facility: Harbor UCLA (Site 1022), 1124 West Carson Street
state: California
city: Westminster
country: United States
facility: Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101
state: California
city: Aurora
country: United States
facility: University of Colorado (Site 1007), 12401 East 17th Avenue
state: Colorado
city: Storrs
country: United States
facility: UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248
state: Connecticut
city: Washington
country: United States
facility: Whitman-Walker Health (Site 1027), 1337 R Street NW.
state: District of Columbia
city: Boynton Beach
country: United States
facility: Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W
state: Florida
city: Bradenton
country: United States
facility: Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350
state: Florida
city: Daytona Beach
country: United States
facility: Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301
state: Florida
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive
state: Florida
city: Doral
country: United States
facility: Integrity Clinical Research (Site 1214), 3901 NW 79th Ave.
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave.
state: Florida
city: Fort Lauderdale
country: United States
facility: EMINAT Research (Site 1202), 2500 E. Commercial Blvd.
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Health (Site 1072), 4725 North Federal Highway
state: Florida
city: Gainesville
country: United States
facility: North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd.
state: Florida
city: Gainesville
country: United States
facility: University of Florida (Site 1047), 1600 SW. Archer Rd.
state: Florida
city: Gulf Breeze
country: United States
facility: NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials (Site 1026), 900 West 49th Street
state: Florida
city: Hialeah
country: United States
facility: Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403
state: Florida
city: Hialeah
country: United States
facility: New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403
state: Florida
city: Hollywood
country: United States
facility: Innovative Health Medical Center (Site 1222), 6750 Taft Street
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Jacksonville (Site 1039), 655 West 8th Street
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S.
state: Florida
city: Miami Beach
country: United States
facility: QC Trials (Site 1117), 300 W. 41st Street, Ste. 203
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research (Site 1037), 5801 NW 151 Street
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street
state: Florida
city: Miami Shores
country: United States
facility: Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue
state: Florida
city: Miami
country: United States
facility: Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street
state: Florida
city: Miami
country: United States
facility: Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave.
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave.
state: Florida
city: Miami
country: United States
facility: Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers (Site 1205), 8485 Bird Road
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research (Site 1089), 2400 SW. 69th Ave.
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201
state: Florida
city: Miami
country: United States
facility: RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St.
state: Florida
city: Miami
country: United States
facility: Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct.
state: Florida
city: North Bay Village
country: United States
facility: Bravo Health Care Center (Site 1221), 1440 79 Street
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center (Site 1045), 1707 North Mills Avenue
state: Florida
city: Orlando
country: United States
facility: Clintheory (Site 1203), 7350 Sandlake Commons Blvd.
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC, Inc. (Site 1141), 18320 Franjo Rd
state: Florida
city: Pembroke Pines
country: United States
facility: Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A
state: Florida
city: Sebring
country: United States
facility: Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N.
state: Florida
city: Tamarac
country: United States
facility: DBC Research (Site 1188), 7707 N. University Dr., Ste. 106
state: Florida
city: Tamarac
country: United States
facility: ETNA Medical Center (Site 1225), 7401 N. University Drive
state: Florida
city: Tampa
country: United States
facility: Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd.
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street
state: Florida
city: Vero Beach
country: United States
facility: Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201
state: Florida
city: Vero Beach
country: United States
facility: AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4
state: Florida
city: Atlanta
country: United States
facility: The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast
state: Georgia
city: Atlanta
country: United States
facility: Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive
state: Georgia
city: Buford
country: United States
facility: Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109
state: Georgia
city: Columbus
country: United States
facility: IACT Health (Site 1035), 800 Talbotton Road
state: Georgia
city: Duluth
country: United States
facility: Clintheory (Site 1254), 4300 Pleasant Hill Road
state: Georgia
city: Norcross
country: United States
facility: One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160
state: Georgia
city: Snellville
country: United States
facility: Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd.
state: Georgia
city: Honolulu
country: United States
facility: John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St.
state: Hawaii
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC (Site 1120), 2900 Cortez Ave.
state: Idaho
city: Burr Ridge
country: United States
facility: Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201
state: Illinois
city: Chicago
country: United States
facility: Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd.
state: Illinois
city: Chicago
country: United States
facility: Northwestern University (Site 1025), 645 North Michigan Ave
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center (Site 1017), 600 Paulina St.
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago (Site 1147), 835 South Wood Street
state: Illinois
city: Chicago
country: United States
facility: University of Chicago (Site 1064), 5841 S. Maryland Ave.
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave.
state: Illinois
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100
state: Indiana
city: Indianapolis
country: United States
facility: Roudebush VA Medical Center (Site 1217), 550 University Blvd
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard
state: Kansas
city: Metairie
country: United States
facility: MedPharmics (Site 1065), 3800 Houma Blvd.
state: Louisiana
city: Monroe
country: United States
facility: Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore VA Medical Center (Site 1258), 10 N. Greene St.
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University (Site 1006), 1830 East Monument Street
state: Maryland
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital (Site 1016), 55 Fruit Street
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N.
state: Massachusetts
city: Dearborn
country: United States
facility: Vida Clinical Studies (Site 1244), 3815 Pelham Street
state: Michigan
city: Farmington Hills
country: United States
facility: Revive Research Institute (Site 1257), 32255 Northwestern Hwy.
state: Michigan
city: Sterling Heights
country: United States
facility: Revival Research Corporation (Site 1256), 13409 East 14 Mile Road
state: Michigan
city: Gulfport
country: United States
facility: Memorial Hospital at Gulfport (Site 1104), 4500 13th Street
state: Mississippi
city: Gulfport
country: United States
facility: MedPharmics, LLC. (Site 1032), 15190 Community Rd.
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri Health Care System (Site 1224), 1 Hospital Drive
state: Missouri
city: Hannibal
country: United States
facility: Hannibal Clinic (Site 1129), 100 Medical Drive
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103
state: Montana
city: Butte
country: United States
facility: Mercury Street Medical Group (Site 1074), 300 W. Mercury St.
state: Montana
city: Omaha
country: United States
facility: Quality Clinical Research (Site 1112), 10040 Regency Circle
state: Nebraska
city: Las Vegas
country: United States
facility: Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd.
state: Nevada
city: Santa Fe
country: United States
facility: AXCES Research Group (Site 1152), 531 Harkle Road
state: New Mexico
city: Bronx
country: United States
facility: Bronx Prevention Research Center (Site 1108), 390 East 158th Street
state: New York
city: Bronx
country: United States
facility: Lincoln Hospital (Site 1092), 249 East 149th Street
state: New York
city: Bronx
country: United States
facility: Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South
state: New York
city: Bronx
country: United States
facility: James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center (Site 1138), 4802 10th Avenue
state: New York
city: Buffalo
country: United States
facility: University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street
state: New York
city: Flushing
country: United States
facility: Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd
state: New York
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway
state: New York
city: New York
country: United States
facility: Columbia Partnership for Prevention and Control of HIV/AIDS CTU (Site 1019), Columbia University Irving Medical Center, Department of Medicine - Division of Infectious Diseases, 180 Fort Washington Avenue, HP6 - Rm 604
state: New York
city: New York
country: United States
facility: Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street
state: New York
city: Potsdam
country: United States
facility: Canton-Potsdam Hospital (Site 1076), 50 Leroy Street
state: New York
city: Rochester
country: United States
facility: University of Rochester (Site 1010), 601 Elmwood Ave
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd.
state: North Carolina
city: Denver
country: United States
facility: Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center (Site 1041), 40 Duke Medicine Circle
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct.
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard
state: North Carolina
city: Fargo
country: United States
facility: Sanford Health (Site 1084), 801 Broadway N.
state: North Dakota
city: Cincinnati
country: United States
facility: The Christ Hospital (Site 1119), 2123 Auburn Avenue
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University (Site 1033), 2061 Cornell Road
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr.
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center (Site 1020), 480 Medical Center Drive
state: Ohio
city: Ohio City
country: United States
facility: Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way
state: Ohio
city: Springboro
country: United States
facility: STAT Research (Site 1107), 66 Remick Blvd.
state: Ohio
city: Tulsa
country: United States
facility: Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street
state: Oklahoma
city: Portland
country: United States
facility: Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave.
state: Oregon
city: Portland
country: United States
facility: Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd.
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue
state: Oregon
city: Doylestown
country: United States
facility: Doylestown Hospital (Site 1122), 595 W. State Street
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania (Site 1031), 3400 Spruce Street
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The University of Pittsburgh (Site 1018), 3471 5th Ave.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C.
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue
state: Rhode Island
city: Columbia
country: United States
facility: Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2
state: South Carolina
city: West Columbia
country: United States
facility: Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D
state: South Carolina
city: Rapid City
country: United States
facility: American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center (Site 1078), 1305 W. 18th St.
state: South Dakota
city: Franklin
country: United States
facility: Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183
state: Tennessee
city: Bellaire
country: United States
facility: Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560
state: Texas
city: Boerne
country: United States
facility: South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road
state: Texas
city: Brownsville
country: United States
facility: PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd.
state: Texas
city: Dallas
country: United States
facility: Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue
state: Texas
city: Dallas
country: United States
facility: UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court
state: Texas
city: Edinburg
country: United States
facility: Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd.
state: Texas
city: Galveston
country: United States
facility: Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive
state: Texas
city: Houston
country: United States
facility: Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495
state: Texas
city: Houston
country: United States
facility: Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital (Site 1123), 6565 Fannin Street
state: Texas
city: Houston
country: United States
facility: Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy
state: Texas
city: Houston
country: United States
facility: Fairway Medical Clinic (Site 1156), 4910 Telephone Road
state: Texas
city: Humble
country: United States
facility: Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100
state: Texas
city: Mesquite
country: United States
facility: SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave.
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research, LLC (Site 1233), 106 Plaza Drive
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr.
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201
state: Virginia
city: Kirkland
country: United States
facility: EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77
state: Washington
city: Seattle
country: United States
facility: University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave.
state: Washington
city: Spokane
country: United States
facility: Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W
state: Washington
city: Huntington
country: United States
facility: Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive
state: West Virginia
city: Morgantown
country: United States
facility: West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive
state: West Virginia
city: Milwaukee
country: United States
facility: Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road
state: Wisconsin
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200
state: Wisconsin
city: La Plata
country: Argentina
facility: Instituto Médico Platense (Site 3011), Avenida 51 335
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240
state: Ciudad Autónoma De Buenos Aires
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020
state: Córdoba
city: Rosario
country: Argentina
facility: Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428
state: Santa Fe
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Clínica Adventista Belgrano (Site 3007), Estomba 1710
city: Mar Del Plata
country: Argentina
facility: Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345
city: Pilar
country: Argentina
facility: Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui
city: Brasília
country: Brazil
facility: L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6
state: Distrito Federal
city: Belo Horizonte
country: Brazil
facility: Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141
state: Santa Catarina
city: Ribeirão Preto
country: Brazil
facility: Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365
city: São Paulo
country: Brazil
facility: Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n
city: Kelowna
country: Canada
facility: Medical Arts Health Research Group (Site 2003), 360-1855 Kirschner Rd.
state: British Columbia
city: Ciudad De Guatemala
country: Guatemala
facility: Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16
city: Torreon
country: Mexico
facility: CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur
state: Coahuila
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana
state: Jalisco
city: Culiacán
country: Mexico
facility: Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios
state: Sinaloa
city: Culiacán
country: Mexico
facility: Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422
state: Sinaloa
city: Mérida
country: Mexico
facility: Eme Red Hospitalaria (Site 6010), Calle 33 No. 496
state: Yucatán
city: Mérida
country: Mexico
facility: Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés
state: Yucatán
city: Cavite City
country: Philippines
facility: De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue
state: Cavite
city: Makati City
country: Philippines
facility: Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village
state: National Capital Region
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive
state: National Capital Region
city: San Juan
country: Puerto Rico
facility: Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II
city: Kempton Park
country: South Africa
facility: Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads
state: Ekurhuleni, Gauteng
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue
state: Gauteng
city: Johannesburg
country: South Africa
facility: The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive
state: Gauteng
city: Johannesburg
country: South Africa
facility: Roodepoort Medicross (Site 9220), 54 Ontdekkers Road
state: Gauteng
city: Johannesburg
country: South Africa
facility: Soweto ACTG CRS (Site 9203), Chris Hani Road
state: Gauteng
city: Johannesburg
country: South Africa
facility: Helen Joseph Hospital (Site 9201), Perth Road
state: Gauteng
city: Pretoria
country: South Africa
facility: Setshaba Research Centre (Site 9205), 2088 Block H
state: Gauteng
city: Tshwane
country: South Africa
facility: Into Research (Site 9210), Totius Street
state: Gauteng
city: Durban
country: South Africa
facility: Durban International Clinical Research Site (Site 9208), Sidmouth Avenue
state: Kwazulu - Natal
city: Welkom
country: South Africa
facility: Welkom Clinical Trial Centre (Site 9211), 189 Power Road
state: Matjhabeng, Free State
city: Klerksdorp
country: South Africa
facility: The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St.
state: North-West
city: Rustenburg
country: South Africa
facility: The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St.
state: North-West
city: George
country: South Africa
facility: TASK Eden (Site 9218), G, 4 Victoria St.
city: Johannesburg
country: South Africa
facility: CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue
city: Mpumalanga
country: South Africa
facility: Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete
city: Pretoria
country: South Africa
facility: Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street
Study officials:
affiliation: University of California, San Diego
name: David Smith, MD, MAS
role: STUDY_CHAIR
References:
citation: Currier JS, Moser C, Eron JJ, Chew KW, Smith DM, Javan AC, Wohl DA, Daar ES, Hughes MD; ACTIV-2/A5401 Study Team. ACTIV-2: A Platform Trial for the Evaluation of Novel Therapeutics for the Treatment of Early COVID-19 in Outpatients. J Infect Dis. 2023 Aug 31;228(Suppl 2):S77-S82. doi: 10.1093/infdis/jiad246.
citation: Chew KW, Moser C, Yeh E, Wohl DA, Daar ES, Ritz J, Javan AC, Eron JJ, Currier JS, Smith DM, Hughes MD; ACTIV-2/A5401 Study Team. Validity and Characterization of Time to Symptom Resolution Outcome Measures in the ACTIV-2/A5401 Outpatient COVID-19 Treatment Trial. J Infect Dis. 2023 Aug 31;228(Suppl 2):S83-S91. doi: 10.1093/infdis/jiad300.
citation: Moser CB, Chew KW, Ritz J, Newell M, Javan AC, Eron JJ, Daar ES, Wohl DA, Currier JS, Smith DM, Hughes MD; ACTIV-2/A5401 Study Team. Pooling Different Placebos as a Control Group in a Randomized Platform Trial: Benefits and Challenges From Experience in the ACTIV-2 COVID-19 Trial. J Infect Dis. 2023 Aug 31;228(Suppl 2):S92-S100. doi: 10.1093/infdis/jiad209.
citation: Moser CB, Chew KW, Giganti MJ, Li JZ, Aga E, Ritz J, Greninger AL, Javan AC, Bender Ignacio R, Daar ES, Wohl DA, Currier JS, Eron JJ, Smith DM, Hughes MD; ACTIV-2/A5401 Study Team. Statistical Challenges When Analyzing SARS-CoV-2 RNA Measurements Below the Assay Limit of Quantification in COVID-19 Clinical Trials. J Infect Dis. 2023 Aug 31;228(Suppl 2):S101-S110. doi: 10.1093/infdis/jiad285.
citation: Bender Ignacio RA, Wohl DA, Arends R, Pilla Reddy V, Mu Y, Javan AC, Hughes MD, Eron JJ, Currier JS, Smith D, Chew KW, Gibbs M, Fletcher CV. Comparative Pharmacokinetics of Tixagevimab/Cilgavimab (AZD7442) Administered Intravenously Versus Intramuscularly in Symptomatic SARS-CoV-2 Infection. Clin Pharmacol Ther. 2022 Dec;112(6):1207-1213. doi: 10.1002/cpt.2706. Epub 2022 Jul 26.
citation: Boucau J, Chew KW, Choudhary MC, Deo R, Regan J, Flynn JP, Crain CR, Hughes MD, Ritz J, Moser C, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Coombs RW, Fischer WA 2nd, Daar ES, Wohl DA, Eron JJ, Currier JS, Smith DM; POSITIVES study team; Li JZ, Barczak AK; ACTIV-2/A5401 Study Team. Monoclonal antibody treatment drives rapid culture conversion in SARS-CoV-2 infection. Cell Rep Med. 2022 Jul 19;3(7):100678. doi: 10.1016/j.xcrm.2022.100678. Epub 2022 Jun 20.
citation: Chew KW, Moser C, Daar ES, Wohl DA, Li JZ, Coombs RW, Ritz J, Giganti M, Javan AC, Li Y, Choudhary MC, Deo R, Malvestutto C, Klekotka P, Price K, Nirula A, Fischer W, Bala V, Ribeiro RM, Perelson AS, Fletcher CV, Eron JJ, Currier JS; ACTIV-2/A5401 Study Team; Hughes MD, Smith DM. Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19. Nat Commun. 2022 Aug 22;13(1):4931. doi: 10.1038/s41467-022-32551-2.
citation: Li Y, Harrison LJ, Chew KW, Currier JS, Wohl DA, Daar ES, Evering TH, Wu R, Giganti M, Ritz J, Javan AC, Coombs RW, Moser C, Hughes MD, Eron JJ, Smith DM, Li JZ. Nasal and Plasma Severe Acute Respiratory Syndrome Coronavirus 2 RNA Levels Are Associated With Timing of Symptom Resolution in the ACTIV-2 Trial of Nonhospitalized Adults With Coronavirus Disease 2019. Clin Infect Dis. 2023 Feb 18;76(4):734-737. doi: 10.1093/cid/ciac818.
citation: Smith DM, Li JZ, Moser C, Yeh E, Currier JS, Chew KW, Hughes MD; ACTIV-2/A5401 Study Team. Recurrence of Symptoms Following a 2-Day Symptom Free Period in Patients With COVID-19. JAMA Netw Open. 2022 Oct 3;5(10):e2238867. doi: 10.1001/jamanetworkopen.2022.38867.
citation: Choudhary MC, Chew KW, Deo R, Flynn JP, Regan J, Crain CR, Moser C, Hughes MD, Ritz J, Ribeiro RM, Ke R, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Fletcher CV, Daar ES, Wohl DA, Eron JJ, Currier JS, Parikh UM, Sieg SF, Perelson AS, Coombs RW, Smith DM, Li JZ; ACTIV-2/A5401 Study Team. Emergence of SARS-CoV-2 escape mutations during Bamlanivimab therapy in a phase II randomized clinical trial. Nat Microbiol. 2022 Nov;7(11):1906-1917. doi: 10.1038/s41564-022-01254-1. Epub 2022 Oct 26.
citation: Moser C, Li JZ, Eron JJ, Aga E, Daar ES, Wohl DA, Coombs RW, Javan AC, Bender Ignacio RA, Jagannathan P, Ritz J, Sieg SF, Parikh UM, Hughes MD, Currier JS, Smith DM, Chew KW; ACTIV-2/A5401 Study Team. Predictors of SARS-CoV-2 RNA From Nasopharyngeal Swabs and Concordance With Other Compartments in Nonhospitalized Adults With Mild to Moderate COVID-19. Open Forum Infect Dis. 2022 Nov 11;9(11):ofac618. doi: 10.1093/ofid/ofac618. eCollection 2022 Nov.
citation: Ramirez SI, Grifoni A, Weiskopf D, Parikh UM, Heaps A, Faraji F, Sieg SF, Ritz J, Moser C, Eron JJ, Currier JS, Klekotka P, Sette A, Wohl DA, Daar ES, Hughes MD, Chew KW, Smith DM, Crotty S; Accelerating COVID-19 Therapeutic Interventions and Vaccines-2/A5401 (ACTIV-2/A5401) Study Team. Bamlanivimab therapy for acute COVID-19 does not blunt SARS-CoV-2-specific memory T cell responses. JCI Insight. 2022 Dec 22;7(24):e163471. doi: 10.1172/jci.insight.163471.
citation: Jilg N, Chew KW, Giganti MJ, Daar ES, Wohl DA, Javan AC, Kantor A, Moser C, Coombs RW, Neytman G, Hoover K, Jana A, Hart PA, Greninger AL, Szurgot B, Eron JJ, Currier JS, Hughes MD, Smith DM, Li JZ; ACTIV-2/A5401 Study Team. One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial. Clin Infect Dis. 2023 Oct 5;77(7):941-949. doi: 10.1093/cid/ciad342.
citation: Taiwo BO, Chew KW, Moser C, Wohl DA, Daar ES, Li JZ, Greninger AL, Bausch C, Luke T, Hoover K, Neytman G, Giganti MJ, Olefsky M, Javan AC, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM; ACTIV-2/A5401 Study Team. Phase 2 Safety and Antiviral Activity of SAB-185, a Novel Polyclonal Antibody Therapy for Nonhospitalized Adults With COVID-19. J Infect Dis. 2023 Jul 14;228(2):133-142. doi: 10.1093/infdis/jiad013.
citation: Evering TH, Chew KW, Giganti MJ, Moser C, Pinilla M, Wohl DA, Currier JS, Eron JJ, Javan AC, Bender Ignacio R, Margolis D, Zhu Q, Ma J, Zhong L, Yan L, D'Andrea Nores U, Hoover K, Mocherla B, Choudhary MC, Deo R, Ritz J, Fischer WA, Fletcher CV, Li JZ, Hughes MD, Smith D, Daar ES; ACTIV-2/A5401 Study Team. Safety and Efficacy of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies Amubarvimab Plus Romlusevimab in Nonhospitalized Patients With COVID-19. Ann Intern Med. 2023 May;176(5):658-666. doi: 10.7326/M22-3428. Epub 2023 Apr 18.
citation: Bender Ignacio RA, Chew KW, Moser C, Currier JS, Eron JJ, Javan AC, Giganti MJ, Aga E, Gibbs M, Tchouakam Kouekam H, Johnsson E, Esser MT, Hoover K, Neytman G, Newell M, Daar ES, Fischer W, Fletcher CV, Li JZ, Greninger AL, Coombs RW, Hughes MD, Smith D, Wohl DA; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-2/A5401 Study Team. Safety and Efficacy of Combined Tixagevimab and Cilgavimab Administered Intramuscularly or Intravenously in Nonhospitalized Patients With COVID-19: 2 Randomized Clinical Trials. JAMA Netw Open. 2023 Apr 3;6(4):e2310039. doi: 10.1001/jamanetworkopen.2023.10039.
citation: Deo R, Choudhary MC, Moser C, Ritz J, Daar ES, Wohl DA, Greninger AL, Eron JJ, Currier JS, Hughes MD, Smith DM, Chew KW, Li JZ; ACTIV-2/A5401 Study Team. Symptom and Viral Rebound in Untreated SARS-CoV-2 Infection. Ann Intern Med. 2023 Mar;176(3):348-354. doi: 10.7326/M22-2381. Epub 2023 Feb 21.
citation: Li Y, Moser C, Aga E, Currier JS, Wohl DA, Daar ES, Ritz J, Greninger AL, Sieg S, Parikh UM, Coombs RW, Hughes MD, Eron JJ, Smith DM, Chew KW, Li JZ; ACTIV-2/A5401 Study Team. Immune Status and SARS-CoV-2 Viral Dynamics. J Infect Dis. 2023 Aug 31;228(Suppl 2):S111-S116. doi: 10.1093/infdis/jiad200.
citation: Giganti MJ, Chew KW, Eron JJ, Li JZ, Pinilla M, Moser C, Javan AC, Fischer WA, Klekotka P, Margolis D, Wohl DA, Coombs RW, Daar ES, Smith DM, Currier JS, Hughes MD; ACTIV-2/A5401 Study Team. Association Between Anterior Nasal and Plasma SARS-CoV-2 RNA Levels and Hospitalization or Death in Nonhospitalized Adults With Mild-to-Moderate COVID-19. J Infect Dis. 2023 Aug 31;228(Suppl 2):S117-S125. doi: 10.1093/infdis/jiad287.
citation: Evering TH, Moser CB, Jilg N, Yeh E, Sanusi B, Wohl DA, Daar ES, Li JZ, Klekotka P, Javan AC, Eron JJ, Currier JS, Hughes MD, Smith DM, Chew KW; ACTIV-2/A5401 Study Team. Long COVID After Bamlanivimab Treatment. J Infect Dis. 2023 Aug 31;228(Suppl 2):S126-S135. doi: 10.1093/infdis/jiad286.
citation: Ribeiro RM, Choudhary MC, Deo R, Giganti MJ, Moser C, Ritz J, Greninger AL, Regan J, Flynn JP, Wohl DA, Currier JS, Eron JJ, Hughes MD, Smith DM, Chew KW, Daar ES, Perelson AS, Li JZ; ACTIV-2/A5401 Study Team. Variant-Specific Viral Kinetics in Acute COVID-19. J Infect Dis. 2023 Aug 31;228(Suppl 2):S136-S143. doi: 10.1093/infdis/jiad314.
citation: Kara W. Chew, Carlee B. Moser, Eric S. Daar, David A. Wohl, Eunice Yeh, Justin Ritz, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Davey M. Smith, Michael D. Hughes, for the ACTIV-2/A5401 Study Team. SYMPTOM OUTCOME MEASURES FOR OUTPATIENT COVID-19 PHASE 3 TREATMENT TRIALS. Presented at conference, 03/10/2021. 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021, Chicago, IL and/or Virtual, 03/06/2021 - 03/10/2021. (A5401)
citation: Kara W. Chew, Carlee B. Moser, Jonathan Z. Li, Robert W. Coombs, Eric S. Daar, David A. Wohl, Evgenia Aga, Justin Ritz, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Michael D. Hughes, Davey M. Smith, for the ACTIV-2/A5401 Study Team. SARS-CoV-2 RNA LEVELS CORRELATE WITH SYMPTOM DURATION BUT NOT SEVERITY IN OUTPATIENTS. Presented at conference, 03/10/2021. 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021, Chicago, IL and/or Virtual, 03/06/2021 - 03/10/2021. (A5401)
citation: Teresa H. Evering, Mark J. Giganti, Kara W. Chew, Michael D. Hughes, Carlee B. Moser, David A. Wohl, Judith S. Currier, Joseph J. Eron, Arzhang Cyrus Javan, David Margolis, Qing Zhu, Ulises D'Andrea, Keila Hoover, Bharat R. Mocherla, Courtney Fletcher, Jonathan Li, Davey M. Smith, Eric S. Daar. SAFETY AND EFFICACY OF COMBINATION SARS-CoV-2 MONOCLONAL NEUTRALIZING ANTIBODIES (MAB) BRII-196 AND BRII-198 IN NON-HOSPITALIZED COVID-19 PATIENTS. Presented at conference, 09/30/2021. 2021 IDWeek, Virtual, 09/20/2021 - 10/03/2021
citation: Teresa H. Evering, Busola Sanusi, Nikolaus Jilg, Eunice Yeh, Carlee B. Moser, Justin Ritz, David A. Wohl, Eric S. Daar, Paul Klekotka, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Michael D. Hughes, Davey M. Smith, and Kara W. Chew, on behalf of the ACTIV-2/A5401 Study Team and Investigators. PREVALENCE AND CHARACTERISTICS OF POST-ACUTE SEQUELAE OF SARS¬-CoV¬-2 (PASC) IN NON¬-HOSPITALIZED PERSONS WITH COVID-¬19 ENROLLED IN A CLINICAL TRIAL OF EARLY TREATMENT (ACTIV-2). Presented at conference, 12/06/2021. 2021 International Workshop on Long-term Complications of HIV and SARS-¬CoV-¬2, Virtual, 12/06/2021 - 12/09/2021. (A5401)
citation: Nikolaus Jilg, Kara W. Chew, Mark J. Giganti, Eric S. Daar, David A. Wohl, Arzhang Cyrus Javan, Amy Kantor, Atasi Jana, Philip A. Hart, Joseph J. Eron, Judith S. Currier, Michael Hughes, Davey M. Smith, Jonathan Z. Li. CAMOSTAT IS NOT EFFECTIVE FOR MILD-MODERATE COVID-19 IN A PHASE 2 TRIAL OF ACTIV-2. Accepted by conference - oral presentation, 01/20/2022. 2022 Conference on Retroviruses and Opportunistic Infections (CROI 2022), Denver, CO, 02/13/2022 - 02/16/2022. (A5401)
citation: Babafemi O. Taiwo, Kara W. Chew, Mark Giganti, David A. Wohl, Eric S. Daar, Maxine Olefsky, Rick Finnegan, Jake Miles, Arzhang Cyrus Javan, Jonathan Li, Judith S. Currier, Joseph J. Eron, Michael D. Hughes, Davey M. Smith. PHASE-2 EVALUATION OF SAB-185, A POLYCLONAL ANTIBODY TREATMENT FOR COVID-19 IN ACTIV-2. Accepted by conference - poster presentation, 01/20/2022. 2022 Conference on Retroviruses and Opportunistic Infections (CROI 2022), Denver, CO, 02/13/2022 - 02/16/2022. (A5401)
citation: Teresa H. Evering, Busola Sanusi, Nikolaus Jilg, Eunice Yeh, Carlee B. Moser, David A. Wohl, Eric S. Daar, Paul Klekotka, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Michael D. Hughes, Davey M. Smith, Kara W. Chew. POST-ACUTE SEQUELAE OF SARS-¬CoV-¬2 IN NON-¬HOSPITALIZED ACTIV-¬2 TRIAL PARTICIPANTS. Accepted by conference - poster presentation, 12/10/2021. 2022 Conference on Retroviruses and Opportunistic Infections (CROI 2022), Denver, CO, 02/13/2022 - 02/16/2022. (A5401)
citation: Mark J. Giganti, Kara W. Chew, Joseph J. Eron, Jonathan Z. Li, Mauricio Pinilla, Carlee B. Moser, Arzhang Cyrus Javan, William A. Fischer, Paul Klekotka, David Margolis, David A. Wohl, Robert W. Coombs, Eric S. Daar, Davey M. Smith, Michael D. Hughes, Judith S. Currier, for the ACTIV-2/A5401 Study Team. ASSOCIATION BETWEEN ANTERIOR NASAL AND PLASMA SARS-CoV-2 RNA LEVELS AND HOSPITALIZATION OR DEATH FOR NON-HOSPITALIZED ADULTS WITH MILD-TO-MODERATE COVID-19. Accepted by Conference, 06/30/2022. 2022 IDWeek, Washington DC, 10/19/2022 - 10/23/2022. (A5401)
citation: Carlee B. Moser, Jonathan Z. Li, Joseph J. Eron, Evgenia Aga, Eric S. Daar, David A. Wohl, Robert W. Coombs, Arzhang Cyrus Javan, Rachel A Bender Ignacio, Prasanna Jagannathan, Justin Ritz, Scott Sieg, Urvi M. Parikh, Michael D. Hughes, Judith S. Currier, Davey M. Smith, Kara W. Chew. FEMALE SEX AND SARS-CoV-2 SEROSTATUS PREDICT NASOPHARYNGEAL RNA CLEARANCE DURING EARLY COVID-19. Accepted by conference - poster presentation, 09/13/2022. 2022 IDWeek, Washington DC, 10/19/2022 - 10/23/2022. (A5401)
citation: Yijia Li, Linda J. Harrison, Kara W. Chew, Joseph J. Eron, Eric S. Daar, David A. Wohl, Ryan Wu, Carlee B. Moser, Justin Ritz, Arzhang Cyrus Javan, Robert W. Coombs, Michael D. Hughes, Judith S. Currier, Davey M. Smith, Jonathan Z. Li. NASAL AND PLASMA SARS-CoV-2 RNA LEVELS PREDICT TIMING OF SYMPTOM RESOLUTION IN THE ACTIV-2 TRIAL OF NON-HOSPITALIZED ADULTS WITH COVID-19. Accepted by conference - oral presentation, 09/12/2022. 2022 IDWeek, Washington DC, 10/19/2022 - 10/23/2022. (A5401)
citation: Teresa H. Evering*, Carlee B. Moser*, Nikolaus Jilg, Justin Ritz, David A. Wohl, Jonathan Z. Li, David Margolis, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Eric S. Daar, Davey M. Smith*, Michael D. Hughes*, Kara W. Chew*, for the ACTIV-2/A5401 Study Team. *Contributed equally. POST-ACUTE COVID OUTCOMES: AMUBARVIMAB+ROMLUSEVIMAB VS PLACEBO IN THE ACTIV-2 TRIAL. Accepted by conference - poster presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. Submitted for Review, 12/08/2022. (A5401).
citation: Yijia Li, Carlee B. Moser, Evgenia Aga, Judith S. Currier, David A. Wohl, Eric S. Daar, Justin Ritz, Robert W. Coombs, Michael D. Hughes, Joseph J. Eron, Davey M. Smith, Kara W. Chew, Jonathan Z. Li. IMMUNE STATUS AND SARS-COV-2 VIRAL DYNAMICS. Accepted by conference - poster presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
citation: Rinki Deo, Manish C. Choudhary, Carlee B. Moser, Justin Ritz, Eric S. Daar, David A. Wohl, Alexander L. Greninger, Joseph J. Eron, Judith S. Currier, Michael D. Hughes*, Davey M. Smith*, Kara W. Chew*, Jonathan Z. Li*, for the ACTIV-2/A5401 Study Team. *Contributed equally. SYMPTOM AND VIRAL REBOUND IN UNTREATED COVID-19 INFECTION. Accepted by conference - oral presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
citation: Rachel Bender Ignacio*, Kara W. Chew*, Carlee B. Moser, Judith S. Currier, Joseph J. Eron, Arzhang Cyrus Javan, Evgenia Aga, Michael Gibbs, Herve Tchouakam Kouekam, Matthew Newell, Eric S. Daar, Jonathan Z. Li, Michael D. Hughes, Davey M. Smith, and David A. Wohl, for the ACTIV-2/A5401 Study Team. TIXAGEVIMAB/CILGAVIMAB IM AND IV IN SYMPTOMATIC COVID-19: A RANDOMIZED CONTROLLED ACTIV-2 TRIAL. Accepted by conference - poster presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
citation: Nikolaus Jilg, Mark J. Giganti, Kara W. Chew, Kathryn Shaw-Saliba, Justin Ritz, Carlee B. Moser, Teresa H. Evering, Eric S. Daar, Joseph J. Eron, Judith S. Currier, Michael D. Hughes, H. Cliff Lane, Robin L. Dewar*, Davey M. Smith*, Jonathan Z. Li*. *Contributed equally. PLASMA ANTIBODY AND N ANTIGEN STATUS PREDICT OUTCOMES IN OUTPATIENTS WITH COVID-19. Accepted by conference - poster presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
citation: Prasanna Jagannathan*, Kara W. Chew*, Mark J. Giganti, Michael D. Hughes, Mark Main, Phillip Monk, Arzhang Cyrus Javan, Jonathan Z. Li, David A. Wohl, Eric S. Daar, Joseph J. Eron, Judith S. Currier, Upinder Singh*, Davey M. Smith*, William Fischer*. *Contributed equally. SAFETY AND EFFICACY OF INHALED INTERFERON-β1A (SNG001) IN OUTPATIENTS WITH COVID-19. Accepted by conference - oral presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
citation: Manish C. Choudhary, Rinki Deo, Teresa H. Evering, Kara W. Chew, Mark J. Giganti, Carlee B. Moser, Justin Ritz, David A. Wohl, Judith S. Currier, Joseph J. Eron, David Margolis, Yun Ji, Michael D. Hughes, Davey M. Smith, Eric S. Daar, Jonathan Z. Li for the ACTIV-2/A5401 Study Team. CHARACTERIZATION OF SINGLE VERSUS DUAL ACTIVE MONOCLONAL ANTIBODIES AGAINST SARS-CoV-2. Accepted by conference - oral presentation. 2023 30th Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA, 02/19/2023 - 02/22/2023. (A5401)
citation: Jagannathan P, Chew KW, Giganti MJ, Hughes MD, Moser C, Main MJ, Monk PD, Javan AC, Li JZ, Fletcher CV, McCarthy C, Wohl DA, Daar ES, Eron JJ, Currier JS, Singh U, Smith DM, Fischer W; ACTIV-2/A5401 Study Team. Safety and efficacy of inhaled interferon-beta1a (SNG001) in adults with mild-to-moderate COVID-19: a randomized, controlled, phase II trial. EClinicalMedicine. 2023 Oct 6;65:102250. doi: 10.1016/j.eclinm.2023.102250. eCollection 2023 Nov.
citation: Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
citation: Chew KW, Moser C, Daar ES, Wohl DA, Li JZ, Coombs R, Ritz J, Giganti M, Javan AC, Li Y, Malvestutto C, Klekotka P, Price K, Nirula A, Fischer W, Bala V, Ribeiro RM, Perelson AS, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM; ACTIV-2/A5401 Study Team. Bamlanivimab reduces nasopharyngeal SARS-CoV-2 RNA levels but not symptom duration in non-hospitalized adults with COVID-19: A Phase 2 Randomized Clinical Trial. medRxiv [Preprint]. 2021 Dec 21:2021.12.17.21268009. doi: 10.1101/2021.12.17.21268009.
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.