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
Enrollment
251
Locations
15
Arms
34.1
Anticipated Duration (Months)
16.1
Patients Per Site
0.5
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1Pinnacle Research Group (Site 1082), 321 E. 10th StreetAnnistonAlabamaUnited States36207-5707
    2North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. BAthensAlabamaUnited States35611-2456
    3University of Alabama at Birmingham (Site 1005), 908 20th Street SouthBirminghamAlabamaUnited States35294
    4Cullman Clinical Trials (Site 1140), 501 Clark St. NE.CullmanAlabamaUnited States35055-1921
    5Jasper Summit Research, LLC. (Site 1056), 1280 SummitJasperAlabamaUnited States35501-0102
    6Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211PhoenixArizonaUnited States85051
    7University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410TucsonArizonaUnited States85724-0001
    8Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. IAnaheimCaliforniaUnited States92804-3729
    9Franco A. Felizarta MD (Site 1174), 3535 San Dimas St.BakersfieldCaliforniaUnited States93301-1661
    10Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103Canyon CountryCaliforniaUnited States91351-4138
    11St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd.FullertonCaliforniaUnited States92835-3820
    12University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer CancerLa JollaCaliforniaUnited States92037
    13Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320La MesaCaliforniaUnited States91942-7001
    14Atella Clinical Research (Site 1111), 5451 La Palma AvenueLa PalmaCaliforniaUnited States90623
    15Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. CLoma LindaCaliforniaUnited States92354
    16University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349Los AngelesCaliforniaUnited States90033-1021
    17UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100Los AngelesCaliforniaUnited States90035
    18Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100Los AngelesCaliforniaUnited States90094-2994
    19VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital WayMatherCaliforniaUnited States95655-4200
    20Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5ModestoCaliforniaUnited States95350-5365
    21Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr.Newport BeachCaliforniaUnited States92663-4126
    22Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210NorthridgeCaliforniaUnited States91325-4138
    23University of California Irvine (Site 1083), 843 Health Sciences RoadOrangeCaliforniaUnited States92868
    24FOMAT Medical Research (Site 1136), 300 South A StreetOxnardCaliforniaUnited States93030
    25Eisenhower Medical Center (Site 1040), 39000 Bob Hope DriveRancho MirageCaliforniaUnited States92270-3221
    26Paradigm Research (Site 1150), 3652 Eureka WayReddingCaliforniaUnited States96001-0172
    27Riverside Medical Clinic (Site 1232), 7117 Brockton Ave.RiversideCaliforniaUnited States92506-2658
    28University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd.SacramentoCaliforniaUnited States95817-2201
    29Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave.San BernardinoCaliforniaUnited States92404
    30University of California San Diego (Site 1002), 220 Dickinson StreetSan DiegoCaliforniaUnited States92103
    31Zion Medical Center (Site 1063), 4647 Zion AvenueSan DiegoCaliforniaUnited States92120
    32VA San Diego Health System (Stie 1127), 3350 La JollaSan DiegoCaliforniaUnited States92161-0002
    33University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84San FranciscoCaliforniaUnited States94110
    34San Francisco Research Institute (Site 1210), 2435 Ocean Ave.San FranciscoCaliforniaUnited States94127-2606
    35Stanford University (Site 1213), 1201 Welch RoadStanfordCaliforniaUnited States94305-5102
    36Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208Thousand OaksCaliforniaUnited States91360-3994
    37Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301Thousand OaksCaliforniaUnited States91360-8005
    38Harbor UCLA (Site 1022), 1124 West Carson StreetTorranceCaliforniaUnited States90502
    39Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101WestminsterCaliforniaUnited States92683-4454
    40University of Colorado (Site 1007), 12401 East 17th AvenueAuroraColoradoUnited States80045
    41UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248StorrsConnecticutUnited States06269-1248
    42Whitman-Walker Health (Site 1027), 1337 R Street NW.WashingtonDistrict of ColumbiaUnited States20009
    43Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2Boynton BeachFloridaUnited States33435-5610
    44Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. WBradentonFloridaUnited States34205-1704
    45Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350BradentonFloridaUnited States34208-1004
    46Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301Daytona BeachFloridaUnited States32117-5157
    47Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood DriveDeLandFloridaUnited States32720-0920
    48Integrity Clinical Research (Site 1214), 3901 NW 79th Ave.DoralFloridaUnited States33166-6508
    49Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave.DoralFloridaUnited States33166-6658
    50EMINAT Research (Site 1202), 2500 E. Commercial Blvd.Fort LauderdaleFloridaUnited States33308
    51Holy Cross Health (Site 1072), 4725 North Federal HighwayFort LauderdaleFloridaUnited States33308
    52North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd.GainesvilleFloridaUnited States32608-1135
    53University of Florida (Site 1047), 1600 SW. Archer Rd.GainesvilleFloridaUnited States32610-3003
    54NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze ParkwayGulf BreezeFloridaUnited States32561
    55Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300HialeahFloridaUnited States33012-4174
    56AGA Clinical Trials (Site 1026), 900 West 49th StreetHialeahFloridaUnited States33012
    57Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403HialeahFloridaUnited States33016-1811
    58New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106HialeahFloridaUnited States33016-1895
    59Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403HialeahFloridaUnited States33016-6890
    60Innovative Health Medical Center (Site 1222), 6750 Taft StreetHollywoodFloridaUnited States33024
    61University of Florida Jacksonville (Site 1039), 655 West 8th StreetJacksonvilleFloridaUnited States32209
    62Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S.JacksonvilleFloridaUnited States32224-1865
    63QC Trials (Site 1117), 300 W. 41st Street, Ste. 203Miami BeachFloridaUnited States33140-3627
    64Lakes Research (Site 1037), 5801 NW 151 StreetMiami LakesFloridaUnited States33014
    65Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st StreetMiami LakesFloridaUnited States33014
    66Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd AvenueMiami ShoresFloridaUnited States33138
    67Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th StreetMiamiFloridaUnited States33125
    68Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave.MiamiFloridaUnited States33135-2906
    69Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701MiamiFloridaUnited States33135-2968
    70University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave.MiamiFloridaUnited States33136
    71Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103MiamiFloridaUnited States33155-2164
    72D&H National Research Centers (Site 1205), 8485 Bird RoadMiamiFloridaUnited States33155-3244
    73Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220MiamiFloridaUnited States33155-4630
    74Miami Clinical Research (Site 1089), 2400 SW. 69th Ave.MiamiFloridaUnited States33155
    75Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201MiamiFloridaUnited States33173-4648
    76RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St.MiamiFloridaUnited States33174-1746
    77Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd StreetMiamiFloridaUnited States33175-3437
    78Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct.MiamiFloridaUnited States33176-2230
    79Bravo Health Care Center (Site 1221), 1440 79 StreetNorth Bay VillageFloridaUnited States33141
    80Orlando Immunology Center (Site 1045), 1707 North Mills AvenueOrlandoFloridaUnited States32803
    81Clintheory (Site 1203), 7350 Sandlake Commons Blvd.OrlandoFloridaUnited States32819
    82IMIC, Inc. (Site 1141), 18320 Franjo RdPalmetto BayFloridaUnited States33157-5503
    83Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102Pembroke PinesFloridaUnited States33026-3240
    84Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1ASarasotaFloridaUnited States34239-3132
    85Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N.SebringFloridaUnited States33870-1216
    86DBC Research (Site 1188), 7707 N. University Dr., Ste. 106TamaracFloridaUnited States33321-2954
    87ETNA Medical Center (Site 1225), 7401 N. University DriveTamaracFloridaUnited States33342
    88Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd.TampaFloridaUnited States33609-2230
    89Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th StreetTampaFloridaUnited States33610-1469
    90Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201Vero BeachFloridaUnited States32960-4889
    91AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th PlaceVero BeachFloridaUnited States32960
    92Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4West Palm BeachFloridaUnited States33407-3100
    93The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue NortheastAtlantaGeorgiaUnited States30308
    94Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. BAtlantaGeorgiaUnited States30318-2512
    95Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond DriveAtlantaGeorgiaUnited States30328
    96Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109BufordGeorgiaUnited States30518-8802
    97IACT Health (Site 1035), 800 Talbotton RoadColumbusGeorgiaUnited States31904
    98Clintheory (Site 1254), 4300 Pleasant Hill RoadDuluthGeorgiaUnited States30096
    99One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160NorcrossGeorgiaUnited States30093
    100Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd.SnellvilleGeorgiaUnited States30078-5779
    101John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St.HonoluluHawaiiUnited States96813
    102Snake River Research, PLLC (Site 1120), 2900 Cortez Ave.Idaho FallsIdahoUnited States83404-7554
    103Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201Burr RidgeIllinoisUnited States60527-0872
    104Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd.ChicagoIllinoisUnited States60607-4911
    105Northwestern University (Site 1025), 645 North Michigan AveChicagoIllinoisUnited States60611
    106Rush University Medical Center (Site 1017), 600 Paulina St.ChicagoIllinoisUnited States60612
    107University of Illinois at Chicago (Site 1147), 835 South Wood StreetChicagoIllinoisUnited States60612
    108University of Chicago (Site 1064), 5841 S. Maryland Ave.ChicagoIllinoisUnited States60637-1443
    109Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave.ChicagoIllinoisUnited States60640-2831
    110Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100BrownsburgIndianaUnited States46112-2415
    111Roudebush VA Medical Center (Site 1217), 550 University BlvdIndianapolisIndianaUnited States46202-5149
    112University of Kansas Medical Center (Site 1042), 3901 Rainbow BoulevardKansas CityKansasUnited States66160
    113MedPharmics (Site 1065), 3800 Houma Blvd.MetairieLouisianaUnited States70006
    114Clinical Trials of America, LLC. (Site 1245) 3201 Armand StreetMonroeLouisianaUnited States71201
    115New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904New OrleansLouisianaUnited States70112-2703
    116Louisiana State University Health Sciences Center (Site 1153), 2000 Canal StreetNew OrleansLouisianaUnited States70112-3018
    117Ochsner Clinic Foundation (Site 1218), 1514 Jefferson HighwayNew OrleansLouisianaUnited States70121
    118Baltimore VA Medical Center (Site 1258), 10 N. Greene St.BaltimoreMarylandUnited States21201-1524
    119Johns Hopkins University (Site 1006), 1830 East Monument StreetBaltimoreMarylandUnited States21205
    120Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave.Silver SpringMarylandUnited States20910-7500
    121Massachusetts General Hospital (Site 1016), 55 Fruit StreetBostonMassachusettsUnited States02114
    122Beth Israel Deaconess Medical Center (Site 1166), 110 Francis StreetBostonMassachusettsUnited States02215
    123Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis StreetBostonMassachusettsUnited States02215
    124University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N.WorcesterMassachusettsUnited States01655-0002
    125Vida Clinical Studies (Site 1244), 3815 Pelham StreetDearbornMichiganUnited States48124
    126Revive Research Institute (Site 1257), 32255 Northwestern Hwy.Farmington HillsMichiganUnited States48334-1566
    127Revival Research Corporation (Site 1256), 13409 East 14 Mile RoadSterling HeightsMichiganUnited States48312
    128Memorial Hospital at Gulfport (Site 1104), 4500 13th StreetGulfportMississippiUnited States39501
    129MedPharmics, LLC. (Site 1032), 15190 Community Rd.GulfportMississippiUnited States39503
    130University of Missouri Health Care System (Site 1224), 1 Hospital DriveColumbiaMissouriUnited States65212-1000
    131Hannibal Clinic (Site 1129), 100 Medical DriveHannibalMissouriUnited States63401
    132Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200Saint LouisMissouriUnited States63110
    133Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103BozemanMontanaUnited States59715-6911
    134Mercury Street Medical Group (Site 1074), 300 W. Mercury St.ButteMontanaUnited States59701-1652
    135Quality Clinical Research (Site 1112), 10040 Regency CircleOmahaNebraskaUnited States68114
    136Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd.Las VegasNevadaUnited States89113-2215
    137AXCES Research Group (Site 1152), 531 Harkle RoadSanta FeNew MexicoUnited States87505
    138Bronx Prevention Research Center (Site 1108), 390 East 158th StreetBronxNew YorkUnited States10451
    139Lincoln Hospital (Site 1092), 249 East 149th StreetBronxNew YorkUnited States10451
    140Urban Health Plan, Inc. (Site 1243), 1065 Southern BlvdBronxNew YorkUnited States10459-2417
    141Jacobi Medical Center (Site 1105), 1400 Pelham Parkway SouthBronxNew YorkUnited States10461
    142James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge RoadBronxNew YorkUnited States10468
    143Maimonides Medical Center (Site 1138), 4802 10th AvenueBrooklynNew YorkUnited States11219-2916
    144University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell StreetBuffaloNew YorkUnited States14203
    145Flushing Hospital Medical Center (Site 1067), 4500 Parsons BlvdFlushingNew YorkUnited States11355-2205
    146Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck ExpresswayJamaicaNew YorkUnited States11418-2832
    147Columbia 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 604New YorkNew YorkUnited States10032
    148Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th StreetNew YorkNew YorkUnited States10065
    149Canton-Potsdam Hospital (Site 1076), 50 Leroy StreetPotsdamNew YorkUnited States13676-1786
    150University of Rochester (Site 1010), 601 Elmwood AveRochesterNew YorkUnited States14642
    151SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 CStony BrookNew YorkUnited States11794
    152University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd FloorChapel HillNorth CarolinaUnited States27514
    153Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd.CharlotteNorth CarolinaUnited States38273-5716
    154Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201DenverNorth CarolinaUnited States28037
    155Duke University Medical Center (Site 1041), 40 Duke Medicine CircleDurhamNorth CarolinaUnited States27710
    156Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct.Morehead CityNorth CarolinaUnited States28557
    157Wake Forest University Health Sciences (Site 1038), 1 Medical Center BoulevardWinston-SalemNorth CarolinaUnited States27157-0001
    158Sanford Health (Site 1084), 801 Broadway N.FargoNorth DakotaUnited States58102-3641
    159The Christ Hospital (Site 1119), 2123 Auburn AvenueCincinnatiOhioUnited States45219
    160Case Western Reserve University (Site 1033), 2061 Cornell RoadClevelandOhioUnited States44106-5083
    161MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr.ClevelandOhioUnited States44109-1900
    162Ohio State University Medical Center (Site 1020), 480 Medical Center DriveColumbusOhioUnited States43210
    163Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin WayOhio CityOhioUnited States45219
    164STAT Research (Site 1107), 66 Remick Blvd.SpringboroOhioUnited States45066-9168
    165Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th StreetTulsaOklahomaUnited States74104
    166Providence Portland Medical Center (Site 1098), 4805 NE. Glisan StreetPortlandOregonUnited States97213-2933
    167Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave.PortlandOregonUnited States97227-1110
    168Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd.PortlandOregonUnited States97239-2964
    169Oregon Health and Science University (Site 1259), 3181 SW. 10th AvenuePortlandOregonUnited States97239-3015
    170Doylestown Hospital (Site 1122), 595 W. State StreetDoylestownPennsylvaniaUnited States18901-2554
    171University of Pennsylvania (Site 1031), 3400 Spruce StreetPhiladelphiaPennsylvaniaUnited States19104
    172The University of Pittsburgh (Site 1018), 3471 5th Ave.PittsburghPennsylvaniaUnited States15213-3215
    173Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C.PittsburghPennsylvaniaUnited States15240
    174The Miriam Hospital Clinical Research Site (1142), 164 Summit AvenueProvidenceRhode IslandUnited States02906
    175Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2ColumbiaSouth CarolinaUnited States29204-2410
    176Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite DWest ColumbiaSouth CarolinaUnited States29169
    177American Indian Clinical Trials Research Network (Site 1148), 717 Meade StreetRapid CitySouth DakotaUnited States57701
    178Sanford USD Medical Center (Site 1078), 1305 W. 18th St.Sioux FallsSouth DakotaUnited States57105-0401
    179Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey DriveFranklinTennesseeUnited States37067
    180Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183NashvilleTennesseeUnited States37204-4718
    181Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560BellaireTexasUnited States77401-4516
    182South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River RoadBoerneTexasUnited States78006
    183PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd.BrownsvilleTexasUnited States78520-7256
    184Trinity Health and Wellness Center (Site 1030), 219 Sunset AvenueDallasTexasUnited States75208
    185UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia CourtDallasTexasUnited States75235
    186Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd.EdinburgTexasUnited States78539
    187Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside DriveGalvestonTexasUnited States77555-0001
    188Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495HoustonTexasUnited States77004-6938
    189Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley StreetHoustonTexasUnited States77026-1967
    190University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112HoustonTexasUnited States77030-1501
    191Houston Methodist Hospital (Site 1123), 6565 Fannin StreetHoustonTexasUnited States77030-2703
    192Dynamic Medical Research Group (Site 1081), 8314 Southwest FwyHoustonTexasUnited States77074-1603
    193Fairway Medical Clinic (Site 1156), 4910 Telephone RoadHoustonTexasUnited States77087
    194Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100HumbleTexasUnited States77338
    195SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave.MesquiteTexasUnited States75149-2438
    196Epic Medical Research, LLC (Site 1233), 106 Plaza DriveRed OakTexasUnited States75154
    197San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr.San AntonioTexasUnited States78234-4504
    198Inova Fairfax Medical Campus (Site 1029), 3300 Gallows RoadFalls ChurchVirginiaUnited States22042-3307
    199Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201RichmondVirginiaUnited States23226-3787
    200EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77KirklandWashingtonUnited States98034-3013
    201University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave.SeattleWashingtonUnited States98104
    202Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050WSpokaneWashingtonUnited States99204-2312
    203Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley DriveHuntingtonWest VirginiaUnited States25704
    204West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center DriveMorgantownWest VirginiaUnited States26506-1200
    205Vida Clinical Studies (Site 1246), 5757 West Oklahoma AvenueMilwaukeeWisconsinUnited States53219
    206Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank RoadMilwaukeeWisconsinUnited States53226
    207Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200WauwatosaWisconsinUnited States53226-1304
    208Instituto Médico Platense (Site 3011), Avenida 51 335La PlataBuenos AiresArgentinaB1900AVG
    209Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240Buenos AiresCiudad Autónoma De Buenos AiresArgentinaC1180AAX
    210Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020Río CuartoCórdobaArgentina5800
    211Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428RosarioSanta FeArgentinaS2013DTC
    212Clínica Adventista Belgrano (Site 3007), Estomba 1710Ciudad Autonoma de Buenos AiresArgentinaC1430EGF
    213Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345Mar Del PlataArgentinaB7602DCK
    214Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, DerquiPilarArgentinaB1629ODT
    215L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6BrasíliaDistrito FederalBrazil70200-730
    216Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190Belo HorizonteMinas GeraisBrazil30130-100
    217SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190Belo HorizonteMinas GeraisBrazil30130-100
    218Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596Porto AlegreRio Grande Do SulBrazil91850-200
    219Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141BlumenauSanta CatarinaBrazil89030-101
    220Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus UniversitárioRibeirão PretoSão PauloBrazil14048-900
    221Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365Rio De JaneiroBrazil21040-360
    222Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/nSão PauloBrazil13059-900
    223Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16Ciudad De GuatemalaGuatemala01011
    224CIMAB SA de CV (Site 6002), Francisco I Madero 270 SurTorreonCoahuilaMexico27000
    225Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia CentroOaxacaDistrito FederalMexico68000
    226Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia CentroGuadalajaraJaliscoMexico44100
    227Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia AmericanaGuadalajaraJaliscoMexico44160
    228Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 riosCuliacánSinaloaMexico80020
    229Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422CuliacánSinaloaMexico80030
    230Eme Red Hospitalaria (Site 6010), Calle 33 No. 496MéridaYucatánMexico97000
    231Kohler and Milstein Research (Site 6013), Avenida Colón 197, García GinerésMéridaYucatánMexico97070
    232De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat AvenueCavite CityCavitePhilippines4114
    233Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi VillageMakati CityNational Capital RegionPhilippines1229
    234Asian Hospital and Medical Center (Site 9503), 2205 Civic DriveMuntinlupaNational Capital RegionPhilippines1780
    235Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building IISan JuanPuerto Rico00935
    236Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument RoadsKempton ParkEkurhuleni, GautengSouth Africa1619
    237Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray AvenueBenoniGautengSouth Africa1501
    238The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane DriveJohannesburgGautengSouth Africa1632
    239Roodepoort Medicross (Site 9220), 54 Ontdekkers RoadJohannesburgGautengSouth Africa1724
    240Soweto ACTG CRS (Site 9203), Chris Hani RoadJohannesburgGautengSouth Africa1862
    241Helen Joseph Hospital (Site 9201), Perth RoadJohannesburgGautengSouth Africa9092
    242Setshaba Research Centre (Site 9205), 2088 Block HPretoriaGautengSouth Africa0152
    243Into Research (Site 9210), Totius StreetTshwaneGautengSouth Africa181
    244Durban International Clinical Research Site (Site 9208), Sidmouth AvenueDurbanKwazulu - NatalSouth Africa4052
    245Welkom Clinical Trial Centre (Site 9211), 189 Power RoadWelkomMatjhabeng, Free StateSouth Africa9459
    246The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St.KlerksdorpNorth-WestSouth Africa2571
    247The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St.RustenburgNorth-WestSouth Africa300
    248TASK Eden (Site 9218), G, 4 Victoria St.GeorgeSouth Africa6530
    249CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine AvenueJohannesburgSouth Africa1619
    250Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve TschweteMpumalangaSouth Africa1055
    251Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko StreetPretoriaSouth Africa2000

    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