ACTIV-2: A Study for Outpatients With COVID-19

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT04518410
Collaborator
Eli Lilly and Company (Industry), AIDS Clinical Trials Group (Other), Brii Biosciences Limited (Industry), AstraZeneca (Industry), Sagent Pharmaceuticals (Industry), Synairgen Research Ltd. (Industry), Bristol-Myers Squibb (Industry), SAb Biotherapeutics, Inc. (Industry)
4,044
251
15
34.1
16.1
0.5

Study Details

Study Description

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

  1. 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.
Condition or Disease Intervention/Treatment Phase
  • Biological: bamlanivimab
  • Drug: Placebo (IV)
  • Biological: BRII-196/BRII-198
  • Biological: AZD7442 (IV)
  • Biological: AZD7442 (IM)
  • Drug: SNG001
  • Drug: Camostat
  • Drug: Placebo (IM)
  • Drug: Placebo (Inhaled solution)
  • Drug: Placebo (oral tablet)
  • Biological: BMS-986414 + BMS-986413
  • Drug: Placebo (SC injections)
  • Biological: SAB-185 (3,840 Units/kg)
  • Biological: SAB-185 (10,240 Units/kg)
  • Drug: CASIRIVIMAB + IMDEVIMAB
Phase 2/Phase 3

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 (monocolonal 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).

Study Design

Study Type:
Interventional
Actual Enrollment :
4044 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Unblinded data will be provided to the Data and Safety Monitoring Board for interim analyses. Unblinded Day 28 data will also be provided to a small group of people from the company who owns the investigational agent, to assist the company in deciding if the agent should move into phase 3 evaluation; or in choosing a dose of their agent to move into phase 3 evaluation.
Primary Purpose:
Treatment
Official Title:
Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
Actual Study Start Date :
Aug 19, 2020
Actual Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Jun 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bamlanivimab

Administered by IV infusion.

Biological: bamlanivimab
7000 mg or 700 mg (Phase 2), 700 mg (Phase 3). Administered by single IV infusion. Phases 2 and 3 completed for bamlanivimab. Participants are no longer being randomized to this intervention.
Other Names:
  • LY3819253
  • Experimental: BRII-196/BRII-198

    Administered by IV infusion.

    Biological: BRII-196/BRII-198
    1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.

    Experimental: AZD7442 (IV)

    Administered by IV infusion.

    Biological: AZD7442 (IV)
    300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
    Other Names:
  • AZD8895 + AZD1061
  • Experimental: Placebo (IV)

    The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and use the same method of administration. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study

    Drug: Placebo (IV)
    Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.

    Experimental: SNG001

    Administered by inhalation.

    Drug: SNG001
    1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.

    Placebo Comparator: Placebo (Inhaled solution)

    The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study

    Drug: Placebo (Inhaled solution)
    Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.

    Experimental: AZD7442 (IM)

    Administered by IM injection.

    Biological: AZD7442 (IM)
    Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
    Other Names:
  • AZD8895 + AZD1061
  • Placebo Comparator: Placebo (IM)

    The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study

    Drug: Placebo (IM)
    Commercially available 0.9% sodium chloride Injection, USP. Administered intramuscularly as 2 separate injections, sequentially for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.

    Experimental: Camostat

    Administered as oral tablets.

    Drug: Camostat
    200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
    Other Names:
  • FOY-305
  • camostat mesilate
  • camostat mesylate
  • Placebo Comparator: Placebo (oral tablets)

    The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study

    Drug: Placebo (oral tablet)
    200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.

    Experimental: BMS 986414 + BMS 986413

    Administered as subcutaneous (SC) injections.

    Biological: BMS-986414 + BMS-986413
    Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
    Other Names:
  • C135-LS + C144-LS
  • Placebo Comparator: Placebo (SC injections)

    The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study

    Drug: Placebo (SC injections)
    Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.

    Experimental: SAB-185 (Lower dose)

    Administered by IV infusion.

    Biological: SAB-185 (3,840 Units/kg)
    Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
    Other Names:
  • Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
  • Experimental: SAB-185 (Higher dose)

    Administered by IV infusion.

    Biological: SAB-185 (10,240 Units/kg)
    Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
    Other Names:
  • Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
  • Active Comparator: Casirivimab + Imdevimab (Phase III only)

    Administered by IV infusion

    Drug: CASIRIVIMAB + IMDEVIMAB
    600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
    Other Names:
  • REGN10933 + REGN10987
  • REGN-COV2
  • Outcome Measures

    Primary Outcome Measures

    1. COVID-19 symptom duration (Phase 2) [Up to Day 28]

      Duration defined as the number of days from start of investigational agent to the first of two consecutive days when any symptoms scored as moderate or severe as study entry (pre-treatment) are scored as mild or absent; and any symptoms scored as mild or absent at study entry are scored as absent, AND any symptoms scored as mile or absent at study entry (pre-treatment) are scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)

    2. Quantification of SARS-CoV-2 RNA (Phase 2) [Day 3]

      Measured as quantification (<LLoQ versus ≥LLoQ ) from staff-collected NP (nasopharyngeal) swabs

    3. Quantification of SARS-CoV-2 RNA (Phase 2) [Day 7]

      Measured as quantification (<LLoQ versus ≥LLoQ ) from staff-collected NP (nasopharyngeal) swabs

    4. Quantification of SARS-CoV-2 RNA (Phase 2) [Day 14]

      Measured as quantification (<LLoQ versus ≥LLoQ ) from staff-collected NP (nasopharyngeal) swabs

    5. Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 2) [Thru Day 28]

    6. Cumulative incidence of death due to any cause or hospitalization due to any cause (Phase 3) [Thru Day 28]

      Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19

    7. Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 3) [Thru Day 28]

    Secondary Outcome Measures

    1. COVID-19 symptom duration (Phase 3) [Thru Day 28]

      Duration defined as the number of days from start of investigational agent to the first of two consecutive days when any symptoms scored as moderate or severe as study entry (pre-treatment) are scored as mild or absent; and any symptoms scored as mild or absent at study entry are scored as absent, AND any symptoms scored as mile or absent at study entry (pre-treatment) are scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)

    2. Quantification of SARS-CoV-2 RNA (Phase 3) [Day 3]

      Measured as quantification (<LLoQ versus ≥LLoQ ) from staff-collected NP (nasopharyngeal) swabs

    3. Cumulative incidence of death from any cause or hospitalization due to any cause (Phase 2) [Thru Day 28]

      Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19

    4. Cumulative incidence of death from any cause, or hospitalization due to any cause related to COVID-19 (Phase 3) [Thru Day 28]

      Hospitalizations due to any cause deemed unrelated to COVID-19 are excluded. Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19

    5. Level of SARS-CoV-2 RNA from NP swabs (Phase 2) [Thru Day 14]

      Measured from staff-collected NP swabs

    6. Level of SARS-CoV-2 RNA from NP swabs (Phase 3) [Day 3]

      Measured from staff-collected NP swabs

    7. Duration of targeted clinical COVID-19 symptoms (Phases 2 and 3) [Thru Day 28]

      Duration defined as the number of days from start of investigational agent to the first of four consecutive days when all symptoms scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)

    8. COVID-19 symptom severity ranking (Phases 2 and 3) [From Day 0 thru Day 28]

      Based on symptom severity scores. Symptoms: 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 (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3). For participants who are alive at 28 days and not previously hospitalized, the severity ranking will be based on the area under the curve (AUC) of the symptom score associated with COVID-19 disease over time. Participants hospitalized or who die during follow-up through 28 days will be ranked as worse than those alive and never hospitalized as follows (in worsening rank order): alive and not hospitalized at 28 days; hospitalized but alive at 28 days; and died at or before 28 days.

    9. Proportion of participants with ≥1 worsening symptom of COVID-19 (Phases 2 and 3) [Thru Day 28]

      Progression of one or more COVID-19-associated symptoms to a worse status than recorded in study diary at study entry, prior to start of investigational product or placebo

    10. Time to self-reported return to usual health (a) (Phases 2 and 3) [Thru Day 28]

      Defined as the number of days from start of investigational treatment until the first of two consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary

    11. Cumulative incidence of death due to any cause or hospitalization due to any cause (Phases 2 and 3) [Day 0 thru Week 24]

    12. Cumulative incidence of death due to any cause or hospitalization due to any cause (Phases 2 and 3) [Day 0 thru Week 72]

    13. Oxygen saturation level (Phases 2 and 3) [Thru Day 28]

      Measured by pulse oximeter and categorized as <96% versus ≥96%

    14. AUC of SARS-CoV-2 RNA from site-collected NP swabs (Phase 2) [Thru Day 14]

      Measured by area under the curve (AUC) and above assay lower limit of quantification of quantitative SARS-CoV-2 RNA over time

    15. Incidence of new adverse event (AE) ≥ Grade 2 (Phases 2 and 3) [Thru Day 28]

    16. Incidence of new adverse event (AE) ≥ Grade 2 (Phases 2 and 3) [Thru Week 24]

    17. Incidence of new adverse event (AE) ≥ Grade 3 (Phases 2 and 3) [Thru Week 24]

    18. Time to self-reported return to usual health (b) (Phases 2 and 3) [Thru Day 28]

      Defined as the number of days from start of investigational treatment until the first of four consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pinnacle Research Group (Site 1082), 321 E. 10th Street Anniston Alabama United States 36207-5707
    2 North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B Athens Alabama United States 35611-2456
    3 University of Alabama at Birmingham (Site 1005), 908 20th Street South Birmingham Alabama United States 35294
    4 Cullman Clinical Trials (Site 1140), 501 Clark St. NE. Cullman Alabama United States 35055-1921
    5 Jasper Summit Research, LLC. (Site 1056), 1280 Summit Jasper Alabama United States 35501-0102
    6 Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211 Phoenix Arizona United States 85051
    7 University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410 Tucson Arizona United States 85724-0001
    8 Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I Anaheim California United States 92804-3729
    9 Franco A. Felizarta MD (Site 1174), 3535 San Dimas St. Bakersfield California United States 93301-1661
    10 Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103 Canyon Country California United States 91351-4138
    11 St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd. Fullerton California United States 92835-3820
    12 University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer La Jolla California United States 92037
    13 Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320 La Mesa California United States 91942-7001
    14 Atella Clinical Research (Site 1111), 5451 La Palma Avenue La Palma California United States 90623
    15 Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C Loma Linda California United States 92354
    16 University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349 Los Angeles California United States 90033-1021
    17 UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100 Los Angeles California United States 90035
    18 Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100 Los Angeles California United States 90094-2994
    19 VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way Mather California United States 95655-4200
    20 Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5 Modesto California United States 95350-5365
    21 Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr. Newport Beach California United States 92663-4126
    22 Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210 Northridge California United States 91325-4138
    23 University of California Irvine (Site 1083), 843 Health Sciences Road Orange California United States 92868
    24 FOMAT Medical Research (Site 1136), 300 South A Street Oxnard California United States 93030
    25 Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive Rancho Mirage California United States 92270-3221
    26 Paradigm Research (Site 1150), 3652 Eureka Way Redding California United States 96001-0172
    27 Riverside Medical Clinic (Site 1232), 7117 Brockton Ave. Riverside California United States 92506-2658
    28 University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd. Sacramento California United States 95817-2201
    29 Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave. San Bernardino California United States 92404
    30 University of California San Diego (Site 1002), 220 Dickinson Street San Diego California United States 92103
    31 Zion Medical Center (Site 1063), 4647 Zion Avenue San Diego California United States 92120
    32 VA San Diego Health System (Stie 1127), 3350 La Jolla San Diego California United States 92161-0002
    33 University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84 San Francisco California United States 94110
    34 San Francisco Research Institute (Site 1210), 2435 Ocean Ave. San Francisco California United States 94127-2606
    35 Stanford University (Site 1213), 1201 Welch Road Stanford California United States 94305-5102
    36 Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208 Thousand Oaks California United States 91360-3994
    37 Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301 Thousand Oaks California United States 91360-8005
    38 Harbor UCLA (Site 1022), 1124 West Carson Street Torrance California United States 90502
    39 Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101 Westminster California United States 92683-4454
    40 University of Colorado (Site 1007), 12401 East 17th Avenue Aurora Colorado United States 80045
    41 UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248 Storrs Connecticut United States 06269-1248
    42 Whitman-Walker Health (Site 1027), 1337 R Street NW. Washington District of Columbia United States 20009
    43 Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2 Boynton Beach Florida United States 33435-5610
    44 Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W Bradenton Florida United States 34205-1704
    45 Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350 Bradenton Florida United States 34208-1004
    46 Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301 Daytona Beach Florida United States 32117-5157
    47 Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive DeLand Florida United States 32720-0920
    48 Integrity Clinical Research (Site 1214), 3901 NW 79th Ave. Doral Florida United States 33166-6508
    49 Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave. Doral Florida United States 33166-6658
    50 EMINAT Research (Site 1202), 2500 E. Commercial Blvd. Fort Lauderdale Florida United States 33308
    51 Holy Cross Health (Site 1072), 4725 North Federal Highway Fort Lauderdale Florida United States 33308
    52 North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd. Gainesville Florida United States 32608-1135
    53 University of Florida (Site 1047), 1600 SW. Archer Rd. Gainesville Florida United States 32610-3003
    54 NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway Gulf Breeze Florida United States 32561
    55 Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300 Hialeah Florida United States 33012-4174
    56 AGA Clinical Trials (Site 1026), 900 West 49th Street Hialeah Florida United States 33012
    57 Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403 Hialeah Florida United States 33016-1811
    58 New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106 Hialeah Florida United States 33016-1895
    59 Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403 Hialeah Florida United States 33016-6890
    60 Innovative Health Medical Center (Site 1222), 6750 Taft Street Hollywood Florida United States 33024
    61 University of Florida Jacksonville (Site 1039), 655 West 8th Street Jacksonville Florida United States 32209
    62 Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S. Jacksonville Florida United States 32224-1865
    63 QC Trials (Site 1117), 300 W. 41st Street, Ste. 203 Miami Beach Florida United States 33140-3627
    64 Lakes Research (Site 1037), 5801 NW 151 Street Miami Lakes Florida United States 33014
    65 Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street Miami Lakes Florida United States 33014
    66 Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue Miami Shores Florida United States 33138
    67 Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street Miami Florida United States 33125
    68 Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave. Miami Florida United States 33135-2906
    69 Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701 Miami Florida United States 33135-2968
    70 University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave. Miami Florida United States 33136
    71 Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103 Miami Florida United States 33155-2164
    72 D&H National Research Centers (Site 1205), 8485 Bird Road Miami Florida United States 33155-3244
    73 Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220 Miami Florida United States 33155-4630
    74 Miami Clinical Research (Site 1089), 2400 SW. 69th Ave. Miami Florida United States 33155
    75 Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201 Miami Florida United States 33173-4648
    76 RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St. Miami Florida United States 33174-1746
    77 Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street Miami Florida United States 33175-3437
    78 Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct. Miami Florida United States 33176-2230
    79 Bravo Health Care Center (Site 1221), 1440 79 Street North Bay Village Florida United States 33141
    80 Orlando Immunology Center (Site 1045), 1707 North Mills Avenue Orlando Florida United States 32803
    81 Clintheory (Site 1203), 7350 Sandlake Commons Blvd. Orlando Florida United States 32819
    82 IMIC, Inc. (Site 1141), 18320 Franjo Rd Palmetto Bay Florida United States 33157-5503
    83 Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102 Pembroke Pines Florida United States 33026-3240
    84 Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A Sarasota Florida United States 34239-3132
    85 Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N. Sebring Florida United States 33870-1216
    86 DBC Research (Site 1188), 7707 N. University Dr., Ste. 106 Tamarac Florida United States 33321-2954
    87 ETNA Medical Center (Site 1225), 7401 N. University Drive Tamarac Florida United States 33342
    88 Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd. Tampa Florida United States 33609-2230
    89 Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street Tampa Florida United States 33610-1469
    90 Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201 Vero Beach Florida United States 32960-4889
    91 AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place Vero Beach Florida United States 32960
    92 Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4 West Palm Beach Florida United States 33407-3100
    93 The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast Atlanta Georgia United States 30308
    94 Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B Atlanta Georgia United States 30318-2512
    95 Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive Atlanta Georgia United States 30328
    96 Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109 Buford Georgia United States 30518-8802
    97 IACT Health (Site 1035), 800 Talbotton Road Columbus Georgia United States 31904
    98 Clintheory (Site 1254), 4300 Pleasant Hill Road Duluth Georgia United States 30096
    99 One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160 Norcross Georgia United States 30093
    100 Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd. Snellville Georgia United States 30078-5779
    101 John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St. Honolulu Hawaii United States 96813
    102 Snake River Research, PLLC (Site 1120), 2900 Cortez Ave. Idaho Falls Idaho United States 83404-7554
    103 Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201 Burr Ridge Illinois United States 60527-0872
    104 Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd. Chicago Illinois United States 60607-4911
    105 Northwestern University (Site 1025), 645 North Michigan Ave Chicago Illinois United States 60611
    106 Rush University Medical Center (Site 1017), 600 Paulina St. Chicago Illinois United States 60612
    107 University of Illinois at Chicago (Site 1147), 835 South Wood Street Chicago Illinois United States 60612
    108 University of Chicago (Site 1064), 5841 S. Maryland Ave. Chicago Illinois United States 60637-1443
    109 Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave. Chicago Illinois United States 60640-2831
    110 Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100 Brownsburg Indiana United States 46112-2415
    111 Roudebush VA Medical Center (Site 1217), 550 University Blvd Indianapolis Indiana United States 46202-5149
    112 University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard Kansas City Kansas United States 66160
    113 MedPharmics (Site 1065), 3800 Houma Blvd. Metairie Louisiana United States 70006
    114 Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street Monroe Louisiana United States 71201
    115 New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904 New Orleans Louisiana United States 70112-2703
    116 Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street New Orleans Louisiana United States 70112-3018
    117 Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway New Orleans Louisiana United States 70121
    118 Baltimore VA Medical Center (Site 1258), 10 N. Greene St. Baltimore Maryland United States 21201-1524
    119 Johns Hopkins University (Site 1006), 1830 East Monument Street Baltimore Maryland United States 21205
    120 Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave. Silver Spring Maryland United States 20910-7500
    121 Massachusetts General Hospital (Site 1016), 55 Fruit Street Boston Massachusetts United States 02114
    122 Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street Boston Massachusetts United States 02215
    123 Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street Boston Massachusetts United States 02215
    124 University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N. Worcester Massachusetts United States 01655-0002
    125 Vida Clinical Studies (Site 1244), 3815 Pelham Street Dearborn Michigan United States 48124
    126 Revive Research Institute (Site 1257), 32255 Northwestern Hwy. Farmington Hills Michigan United States 48334-1566
    127 Revival Research Corporation (Site 1256), 13409 East 14 Mile Road Sterling Heights Michigan United States 48312
    128 Memorial Hospital at Gulfport (Site 1104), 4500 13th Street Gulfport Mississippi United States 39501
    129 MedPharmics, LLC. (Site 1032), 15190 Community Rd. Gulfport Mississippi United States 39503
    130 University of Missouri Health Care System (Site 1224), 1 Hospital Drive Columbia Missouri United States 65212-1000
    131 Hannibal Clinic (Site 1129), 100 Medical Drive Hannibal Missouri United States 63401
    132 Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200 Saint Louis Missouri United States 63110
    133 Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103 Bozeman Montana United States 59715-6911
    134 Mercury Street Medical Group (Site 1074), 300 W. Mercury St. Butte Montana United States 59701-1652
    135 Quality Clinical Research (Site 1112), 10040 Regency Circle Omaha Nebraska United States 68114
    136 Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd. Las Vegas Nevada United States 89113-2215
    137 AXCES Research Group (Site 1152), 531 Harkle Road Santa Fe New Mexico United States 87505
    138 Bronx Prevention Research Center (Site 1108), 390 East 158th Street Bronx New York United States 10451
    139 Lincoln Hospital (Site 1092), 249 East 149th Street Bronx New York United States 10451
    140 Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd Bronx New York United States 10459-2417
    141 Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South Bronx New York United States 10461
    142 James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road Bronx New York United States 10468
    143 Maimonides Medical Center (Site 1138), 4802 10th Avenue Brooklyn New York United States 11219-2916
    144 University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street Buffalo New York United States 14203
    145 Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd Flushing New York United States 11355-2205
    146 Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway Jamaica New York United States 11418-2832
    147 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 New York New York United States 10032
    148 Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street New York New York United States 10065
    149 Canton-Potsdam Hospital (Site 1076), 50 Leroy Street Potsdam New York United States 13676-1786
    150 University of Rochester (Site 1010), 601 Elmwood Ave Rochester New York United States 14642
    151 SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C Stony Brook New York United States 11794
    152 University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor Chapel Hill North Carolina United States 27514
    153 Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd. Charlotte North Carolina United States 38273-5716
    154 Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201 Denver North Carolina United States 28037
    155 Duke University Medical Center (Site 1041), 40 Duke Medicine Circle Durham North Carolina United States 27710
    156 Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct. Morehead City North Carolina United States 28557
    157 Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard Winston-Salem North Carolina United States 27157-0001
    158 Sanford Health (Site 1084), 801 Broadway N. Fargo North Dakota United States 58102-3641
    159 The Christ Hospital (Site 1119), 2123 Auburn Avenue Cincinnati Ohio United States 45219
    160 Case Western Reserve University (Site 1033), 2061 Cornell Road Cleveland Ohio United States 44106-5083
    161 MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr. Cleveland Ohio United States 44109-1900
    162 Ohio State University Medical Center (Site 1020), 480 Medical Center Drive Columbus Ohio United States 43210
    163 Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way Ohio City Ohio United States 45219
    164 STAT Research (Site 1107), 66 Remick Blvd. Springboro Ohio United States 45066-9168
    165 Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street Tulsa Oklahoma United States 74104
    166 Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street Portland Oregon United States 97213-2933
    167 Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave. Portland Oregon United States 97227-1110
    168 Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd. Portland Oregon United States 97239-2964
    169 Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue Portland Oregon United States 97239-3015
    170 Doylestown Hospital (Site 1122), 595 W. State Street Doylestown Pennsylvania United States 18901-2554
    171 University of Pennsylvania (Site 1031), 3400 Spruce Street Philadelphia Pennsylvania United States 19104
    172 The University of Pittsburgh (Site 1018), 3471 5th Ave. Pittsburgh Pennsylvania United States 15213-3215
    173 Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C. Pittsburgh Pennsylvania United States 15240
    174 The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue Providence Rhode Island United States 02906
    175 Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2 Columbia South Carolina United States 29204-2410
    176 Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D West Columbia South Carolina United States 29169
    177 American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street Rapid City South Dakota United States 57701
    178 Sanford USD Medical Center (Site 1078), 1305 W. 18th St. Sioux Falls South Dakota United States 57105-0401
    179 Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive Franklin Tennessee United States 37067
    180 Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183 Nashville Tennessee United States 37204-4718
    181 Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560 Bellaire Texas United States 77401-4516
    182 South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road Boerne Texas United States 78006
    183 PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd. Brownsville Texas United States 78520-7256
    184 Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue Dallas Texas United States 75208
    185 UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court Dallas Texas United States 75235
    186 Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd. Edinburg Texas United States 78539
    187 Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive Galveston Texas United States 77555-0001
    188 Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495 Houston Texas United States 77004-6938
    189 Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street Houston Texas United States 77026-1967
    190 University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112 Houston Texas United States 77030-1501
    191 Houston Methodist Hospital (Site 1123), 6565 Fannin Street Houston Texas United States 77030-2703
    192 Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy Houston Texas United States 77074-1603
    193 Fairway Medical Clinic (Site 1156), 4910 Telephone Road Houston Texas United States 77087
    194 Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100 Humble Texas United States 77338
    195 SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave. Mesquite Texas United States 75149-2438
    196 Epic Medical Research, LLC (Site 1233), 106 Plaza Drive Red Oak Texas United States 75154
    197 San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr. San Antonio Texas United States 78234-4504
    198 Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road Falls Church Virginia United States 22042-3307
    199 Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201 Richmond Virginia United States 23226-3787
    200 EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77 Kirkland Washington United States 98034-3013
    201 University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave. Seattle Washington United States 98104
    202 Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W Spokane Washington United States 99204-2312
    203 Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive Huntington West Virginia United States 25704
    204 West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive Morgantown West Virginia United States 26506-1200
    205 Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue Milwaukee Wisconsin United States 53219
    206 Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road Milwaukee Wisconsin United States 53226
    207 Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200 Wauwatosa Wisconsin United States 53226-1304
    208 Instituto Médico Platense (Site 3011), Avenida 51 335 La Plata Buenos Aires Argentina B1900AVG
    209 Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240 Buenos Aires Ciudad Autónoma De Buenos Aires Argentina C1180AAX
    210 Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020 Río Cuarto Córdoba Argentina 5800
    211 Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428 Rosario Santa Fe Argentina S2013DTC
    212 Clínica Adventista Belgrano (Site 3007), Estomba 1710 Ciudad Autonoma de Buenos Aires Argentina C1430EGF
    213 Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345 Mar Del Plata Argentina B7602DCK
    214 Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui Pilar Argentina B1629ODT
    215 L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6 Brasília Distrito Federal Brazil 70200-730
    216 Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190 Belo Horizonte Minas Gerais Brazil 30130-100
    217 SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190 Belo Horizonte Minas Gerais Brazil 30130-100
    218 Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596 Porto Alegre Rio Grande Do Sul Brazil 91850-200
    219 Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141 Blumenau Santa Catarina Brazil 89030-101
    220 Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário Ribeirão Preto São Paulo Brazil 14048-900
    221 Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365 Rio De Janeiro Brazil 21040-360
    222 Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n São Paulo Brazil 13059-900
    223 Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16 Ciudad De Guatemala Guatemala 01011
    224 CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur Torreon Coahuila Mexico 27000
    225 Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro Oaxaca Distrito Federal Mexico 68000
    226 Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro Guadalajara Jalisco Mexico 44100
    227 Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana Guadalajara Jalisco Mexico 44160
    228 Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios Culiacán Sinaloa Mexico 80020
    229 Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422 Culiacán Sinaloa Mexico 80030
    230 Eme Red Hospitalaria (Site 6010), Calle 33 No. 496 Mérida Yucatán Mexico 97000
    231 Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés Mérida Yucatán Mexico 97070
    232 De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue Cavite City Cavite Philippines 4114
    233 Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village Makati City National Capital Region Philippines 1229
    234 Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive Muntinlupa National Capital Region Philippines 1780
    235 Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II San Juan Puerto Rico 00935
    236 Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads Kempton Park Ekurhuleni, Gauteng South Africa 1619
    237 Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue Benoni Gauteng South Africa 1501
    238 The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive Johannesburg Gauteng South Africa 1632
    239 Roodepoort Medicross (Site 9220), 54 Ontdekkers Road Johannesburg Gauteng South Africa 1724
    240 Soweto ACTG CRS (Site 9203), Chris Hani Road Johannesburg Gauteng South Africa 1862
    241 Helen Joseph Hospital (Site 9201), Perth Road Johannesburg Gauteng South Africa 9092
    242 Setshaba Research Centre (Site 9205), 2088 Block H Pretoria Gauteng South Africa 0152
    243 Into Research (Site 9210), Totius Street Tshwane Gauteng South Africa 181
    244 Durban International Clinical Research Site (Site 9208), Sidmouth Avenue Durban Kwazulu - Natal South Africa 4052
    245 Welkom Clinical Trial Centre (Site 9211), 189 Power Road Welkom Matjhabeng, Free State South Africa 9459
    246 The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St. Klerksdorp North-West South Africa 2571
    247 The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St. Rustenburg North-West South Africa 300
    248 TASK Eden (Site 9218), G, 4 Victoria St. George South Africa 6530
    249 CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue Johannesburg South Africa 1619
    250 Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete Mpumalanga South Africa 1055
    251 Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street Pretoria South Africa 2000

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)
    • Eli Lilly and Company
    • AIDS Clinical Trials Group
    • Brii Biosciences Limited
    • AstraZeneca
    • Sagent Pharmaceuticals
    • Synairgen Research Ltd.
    • Bristol-Myers Squibb
    • SAb Biotherapeutics, Inc.

    Investigators

    • Study Chair: David Smith, MD, MAS, University of California, San Diego

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT04518410
    Other Study ID Numbers:
    • A5401/ACTIV-2
    • 38742
    First Posted:
    Aug 19, 2020
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022