MedPath

EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19

Phase 2
Completed
Conditions
COVID-19
Interventions
Registration Number
NCT04960202
Lead Sponsor
Pfizer
Brief Summary

The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2246
Inclusion Criteria
  • Confirmed SARS-CoV-2 infection within 5 days prior to randomization
  • Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization
  • Fertile participants must agree to use a highly effective method of contraception
  • Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19
Exclusion Criteria
  • History of or need for hospitalization for the medical treatment of COVID-19
  • Prior to current disease episode, any confirmed SARS-CoV-2 infection
  • Known medical history of active liver disease
  • Receiving dialysis or have known moderate to severe renal impairment
  • Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment
  • Suspected or confirmed concurrent active systemic infection other than COVID-19
  • History of hypersensitivity or other contraindication to any of the components of the study intervention
  • Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4
  • Has received or is expected to receive convalescent COVID-19 plasma
  • Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit
  • Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit
  • Known prior participation in this trial or other trial involving PF-07321332
  • Oxygen saturation of <92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition
  • Females who are pregnant or breastfeeding

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboOrally administered placebo
PF-07321332/ritonavirPF-07321332Orally administered PF-07321332+ritonavir
PF-07321332/ritonavirRitonavirOrally administered PF-07321332+ritonavir
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) PopulationFrom Day 1 to Day 28

Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator.

Secondary Outcome Measures
NameTimeMethod
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 PopulationFrom Day 1 (baseline) to Day 28

Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)From start of study intervention (Day 1) up to end of safety follow-up (Day 34)

An AE was any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events.

Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 PopulationFrom Day 1 (baseline) to Day 28

Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)From start of study intervention (Day 1) up to end of safety follow-up (Day 34)

An adverse event (AE) was any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE was considered as TEAE if the event started on or after start date of study intervention.

Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT PopulationFrom Day 1 to Day 28

Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.

Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 PopulationFrom Day 1 to Day 28

Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.

Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 PopulationFrom Day 1 to Day 28

Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.

Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 PopulationFrom Day 1 (baseline) to Day 28

Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT PopulationFrom Day 1 (baseline) to Day 28

Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Plasma Concentration Versus Time Summary of PF-073213321 Hour post-dose on Day 1 and pre-dose on Day 5
Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) PopulationFrom Day 1 to Day 28

Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier method.

Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT PopulationFrom Day 1 (baseline) to Day 28

Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT PopulationFrom Day 1 (baseline) to Day 28

Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Percentage of Participants Who Died Through Week 24- mITT PopulationFrom Day 1 up to Week 24

In this outcome measure, percentage of participants with death due to any cause was presented.

Percentage of Participants Who Died Through Week 24- mITT2 PopulationFrom Day 1 up to Week 24

In this outcome measure, percentage of participants with death due to any cause was presented.

Number of COVID-19 Related Medical Visits- mITT1 PopulationFrom Day 1 up to Day 34

Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.

Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 PopulationFrom Day 1 (baseline) to Day 28

Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 PopulationFrom Day 1 (baseline) to Day 28

Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT PopulationFrom Day 1 (baseline) to Day 28

Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).

Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 PopulationFrom Day 1 (baseline) to Day 28

Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).

Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 PopulationDay 1, 5

In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.

Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 PopulationDay 1, 5

In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.

Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 PopulationBaseline, Day 3, 5, 10 and 14

The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.

Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 PopulationFrom Day 1 up to Day 34
Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) PopulationFrom Day 1 (baseline) to Day 28

Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT PopulationFrom Day 1 (baseline) to Day 28

Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Percentage of Participants Who Died Through Week 24- mITT1 PopulationFrom Day 1 up to Week 24

In this outcome measure, percentage of participants with death due to any cause was presented.

Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 PopulationBaseline, Day 3, 5, 10 and 14

The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.

Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT PopulationFrom Day 1 up to Day 34
Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 PopulationFrom Day 1 (baseline) to Day 28

Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 PopulationFrom Day 1 (baseline) to Day 28

Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.

Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 PopulationFrom Day 1 (baseline) to Day 28

Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= no occurrence, 1= mild for 1 to 2 times, 2= moderate for 3 to 4 times, and 3= severe for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).

Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT PopulationDay 1, 5

In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation \>=95% were reported.

Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT PopulationBaseline, Day 3, 5, 10 and 14

The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).

Number of COVID-19 Related Medical Visits- mITT PopulationFrom Day 1 up to Day 34

Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (intensive care unit \[ICU\] and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.

Number of COVID-19 Related Medical Visits- mITT2 PopulationFrom Day 1 up to Day 34

Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.

Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 PopulationFrom Day 1 up to Day 34

Trial Locations

Locations (199)

Cahaba Research Inc

🇺🇸

Pelham, Alabama, United States

The Institute for Liver Health dba Arizona Clinical Trials

🇺🇸

Tucson, Arizona, United States

Hope Clinical Research

🇺🇸

Canoga Park, California, United States

Ark Clinical Research

🇺🇸

Long Beach, California, United States

South Bay Clinical Research Institute

🇺🇸

Redondo Beach, California, United States

Hope Clinical Research (COVID Satellite Site)

🇺🇸

West Hills, California, United States

Future Innovative Treatments, LLC

🇺🇸

Colorado Springs, Colorado, United States

MOORE Clinical Research, Inc.

🇺🇸

Brandon, Florida, United States

Herco Medical and Research Center Inc

🇺🇸

Coral Gables, Florida, United States

Advance Clinical Research Group

🇺🇸

Cutler Bay, Florida, United States

Beautiful Minds Clinical Research Center

🇺🇸

Cutler Bay, Florida, United States

Unlimited Medical Research Group, LLC

🇺🇸

Hialeah Gardens, Florida, United States

Advanced Pulmonary Research Institute

🇺🇸

Loxahatchee Groves, Florida, United States

Angels Clinical Research Institute

🇺🇸

Miami, Florida, United States

NAPA Research LLC

🇺🇸

Pompano Beach, Florida, United States

CDC Research Institute

🇺🇸

Port Saint Lucie, Florida, United States

GCP, Global Clinical Professionals

🇺🇸

Saint Petersburg, Florida, United States

Sunrise Research Institute

🇺🇸

Sunrise, Florida, United States

USPA Advance Concept Medical Research Group LLC

🇺🇸

South Miami, Florida, United States

New Orleans Sinus Center (COVID-19 Testing)

🇺🇸

Marrero, Louisiana, United States

Tandem Clinical Research GI, LLC

🇺🇸

Marrero, Louisiana, United States

Meridian Clinical Research, LLC

🇺🇸

Endwell, New York, United States

Monroe Biomedical Research

🇺🇸

Monroe, North Carolina, United States

Accellacare

🇺🇸

Wilmington, North Carolina, United States

Premier Medical Group

🇺🇸

Clarksville, Tennessee, United States

PharmaTex Research, LLC

🇺🇸

Amarillo, Texas, United States

St Hope Foundation

🇺🇸

Bellaire, Texas, United States

Conroe Willis Medical Research

🇺🇸

Conroe, Texas, United States

SMS Clinical Research, LLC

🇺🇸

Mesquite, Texas, United States

SMS Clinical Research

🇺🇸

Mesquite, Texas, United States

LinQ Research, LLC

🇺🇸

Pearland, Texas, United States

Epic Medical Research

🇺🇸

Red Oak, Texas, United States

Tranquility Research

🇺🇸

Webster, Texas, United States

TPMG (Tidewater Physicians Multispecialty Group) Clinical Research

🇺🇸

Newport News, Virginia, United States

Hospital Agamenon Magalhaes

🇧🇷

Recife, Pernambuco, Brazil

CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA

🇧🇷

Jau, SAO Paulo, Brazil

Diagnostic-Consultative Center I Lom EOOD

🇧🇬

Lom, Bulgaria

Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD

🇧🇬

Lom, Bulgaria

Medical centre Leo Clinic EOOD

🇧🇬

Lovech, Bulgaria

MHAT Heart and Brain EAD

🇧🇬

Pleven, Bulgaria

MHAT "St. Panteleimon "- Plovdiv

🇧🇬

Plovdiv, Bulgaria

DCC Sveti Georgi EOOD

🇧🇬

Plovdiv, Bulgaria

Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD

🇧🇬

Razgrad, Bulgaria

"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -

🇧🇬

Ruse, Bulgaria

UMHAT Medica Ruse OOD

🇧🇬

Ruse, Bulgaria

Multiprofile Hospital for Active Treatment - Samokov EOOD

🇧🇬

Samokov, Bulgaria

Medical Center-1-Sevlievo EOOD

🇧🇬

Sevlievo, Bulgaria

Multiprofile hospital for active treatment - Sliven to Military Medical Academy

🇧🇬

Sliven, Bulgaria

MHAT "Dr. Ivan Seliminski" AD, Sliven

🇧🇬

Sliven, Bulgaria

MHAT "St. Sofia" EOOD

🇧🇬

Sofia, Bulgaria

Diagnostic-Consultative Center XXII- Sofia ЕООD

🇧🇬

Sofia, Bulgaria

Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD

🇧🇬

Stara Zagora, Bulgaria

Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD

🇧🇬

Vratsa, Bulgaria

Medical center Leo Clinic EOOD

🇧🇬

Varna, Bulgaria

Multiprofile Hospital for Active Treatment Targovishte AD

🇧🇬

Targovishte, Bulgaria

Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD

🇧🇬

Tsarevo, Bulgaria

Fundacion Cardiomet Cequin

🇨🇴

Armenia, Quindio, Colombia

Zdraví-Fit, s.r.o.

🇨🇿

Protivín, Czechia

Nemocnice Slany

🇨🇿

Slany, Czechia

Trial Pharma Kft.

🇭🇺

Gyula, Hungary

Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika

🇭🇺

Debrecen, Hungary

AIIMS Raipur

🇮🇳

Raipur, Chhattisgarh, India

Jupiter Hospital

🇮🇳

Vadodara, Gujarat, India

BGS Global Institute of Medical Sciences and Hospital

🇮🇳

Bangalore, Karnataka, India

Nil Ratan Sircar Medical College and Hospital

🇮🇳

Kolkata, WEST Bengal, India

National Hokkaido Medical Center

🇯🇵

Sapporo, Hokkaido, Japan

International University of Health and Welfare Narita Hospital

🇯🇵

Narita, Chiba, Japan

Tokyo Medical University Hachioji Medical Center

🇯🇵

Hachioji, Tokyo, Japan

Kyungpook National University Chilgok Hospital

🇰🇷

Daegu, Korea, Republic of

Incheon Medical Center

🇰🇷

Incheon, Korea, Republic of

Chonnam National University Bitgoeul Hospital

🇰🇷

Nam-gu, Korea, Republic of

SMG-SNU Boramae Medical Center

🇰🇷

Seoul, Korea, Republic of

Hospital Umum Sarawak

🇲🇾

Kuching, Sarawak, Malaysia

Hospital Miri

🇲🇾

Miri, Sarawak, Malaysia

Clinical Research Institute Saltillo S.A. de C.V.

🇲🇽

Saltillo, Coahuila, Mexico

Instituto Jalisciense de Metabolismo, S.C.

🇲🇽

Guadalajara, Jalisco, Mexico

Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC)

🇲🇽

Pachuca de Soto, Hidalgo, Mexico

JM Research SC

🇲🇽

Cuernavaca, Morelos, Mexico

Christus - Latam Hub Center of Excellence and Innovation Center S.C.

🇲🇽

Monterrey, Nuevo LEON, Mexico

Eukarya Pharmasite S.C.

🇲🇽

Monterrey, Nuevo LEON, Mexico

Oaxaca Site Management Organization

🇲🇽

Oaxaca de Juarez, Oaxaca, Mexico

InfectoLab Consultorios de Especialidad en Infectologia

🇲🇽

Baja California, Tijuana, Mexico

Kohler & Milstein Research S.A. de C.V.

🇲🇽

Merida, Yucatan, Mexico

Centro de Investigacion Clinica Del Pacifico SA de CV

🇲🇽

Acapulco, Mexico

Hospital Cardiologica Aguascalientes

🇲🇽

Aguascalientes, Mexico

FAICIC S. de R.L. de C.V.

🇲🇽

Veracruz, Mexico

Instituto de Investigaciones Clínicas para la Salud

🇲🇽

Durango, Mexico

Sociedad de Metabolismo y Corazon S.C.

🇲🇽

Veracruz, Mexico

Arké SMO S.A de C.V

🇲🇽

Veracruz, Mexico

KLIMED Marek Klimkiewicz

🇵🇱

Bialystok, Poland

Clinical Research Management Group Inc

🇵🇷

Ponce, Puerto Rico

Advance Medical Research Center

🇵🇷

San Juan, Puerto Rico

LLC Trekhgorka Medicine

🇷🇺

Odintsovo, Moscow Region, Russian Federation

MERC Welkom

🇿🇦

Welkom, FREE State, South Africa

Barnaul City Hospital Number 5

🇷🇺

Barnaul, Russian Federation

KDC "Evromedservis", OJSC

🇷🇺

Moscow, Russian Federation

Eba Centelles

🇪🇸

Centelles, Barcelona [barcelona], Spain

Smolensk State Medical University

🇷🇺

Smolensk, Russian Federation

East Rand Research Centre T/A Worthwhile Clinical Trials

🇿🇦

Benoni, Gauteng, South Africa

Botho Ke Bontle Health Services

🇿🇦

Pretoria, Gauteng, South Africa

MERC Middelburg

🇿🇦

Middelburg, Mpumalanga, South Africa

Synapta Clinical Research Center

🇿🇦

Durban, Kwazulu Natal, South Africa

Limpopo Clinical Research Initiative

🇿🇦

Thabazimbi, Limpopo, South Africa

Complexo Hospitalario Universitario da Coruna

🇪🇸

A Coruña, Spain

Faculty of Medicine - Khon Kaen University

🇹🇭

Muang, Khon Kaen, Thailand

Ankara University Medical Faculty, Ibni-Sina Hospital

🇹🇷

Ankara, Turkey

Hacettepe University Medical Faculty Hospital

🇹🇷

Ankara, Turkey

Istanbul Medipol University Clinical Research Ethics Committee

🇹🇷

Beykoz / Istanbul, Turkey

Gaziantep University Medical Faculty

🇹🇷

Gaziantep, Turkey

Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi

🇹🇷

Istanbul, Turkey

Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty

🇹🇷

Istanbul, Turkey

Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi

🇹🇷

Istanbul, Turkey

Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi

🇹🇷

Istanbul, Turkey

Basaksehir Cam ve Sakura Sehir Hastanesi

🇹🇷

Istanbul, Turkey

Kocaeli University Medical Faculty

🇹🇷

Kocaeli, Turkey

Sbü Dr. Suat Seren Göğüs Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi

🇹🇷

Konak/Izmir, Turkey

Mersin University Health Research and Application Hospital

🇹🇷

Mersin, Turkey

Sakarya University Training and Research Hospital

🇹🇷

Sakarya, Turkey

Karadeniz Teknik Universitesi Farabi Hastanesi

🇹🇷

Trabzon, Turkey

Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council

🇺🇦

Dnipro, Ukraine

Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of

🇺🇦

Ivano-Frankivsk, Ukraine

Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"

🇺🇦

Ivano-Frankivsk, Ukraine

Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council

🇺🇦

Kharkiv, Ukraine

Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases

🇺🇦

Kharkiv, Ukraine

"Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council

🇺🇦

Kyiv, Ukraine

Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv

🇺🇦

Kyiv, Ukraine

Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"

🇺🇦

Lviv, Ukraine

Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional

🇺🇦

Poltava, Ukraine

Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council

🇺🇦

Tarasove Village, Ukraine

Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1"

🇺🇦

Vinnytsia, Ukraine

Ascada Research

🇺🇸

Fullerton, California, United States

American Institute of Research

🇺🇸

Los Angeles, California, United States

Xera Med Research

🇺🇸

Boca Raton, Florida, United States

Innovative Research of West Florida, Inc.

🇺🇸

Clearwater, Florida, United States

Qway Research

🇺🇸

Hialeah, Florida, United States

Eastern Research Inc

🇺🇸

Hialeah, Florida, United States

Inpatient Research Clinic

🇺🇸

Hialeah, Florida, United States

Doral Medical Research LLC.

🇺🇸

Hialeah, Florida, United States

Doral Medical Research,LLC

🇺🇸

Hialeah, Florida, United States

Savin Medical Group, LLC

🇺🇸

Miami Lakes, Florida, United States

Clinical Site Partners, Inc. dba CSP Orlando

🇺🇸

Winter Park, Florida, United States

Research by Design, LLC

🇺🇸

Chicago, Illinois, United States

Mercury Street Medical Group, PLLC

🇺🇸

Butte, Montana, United States

South Texas Clinical Research

🇺🇸

Corpus Christi, Texas, United States

SignatureCare Emergency Center

🇺🇸

Houston, Texas, United States

Trio Clinical Trials, LLC

🇺🇸

Houston, Texas, United States

C & R Research Services USA

🇺🇸

Houston, Texas, United States

Next Level Urgent Care

🇺🇸

Houston, Texas, United States

Jehangir Clinical Development Centre Pvt. Ltd

🇮🇳

Pune, Maharashtra, India

Apex Hospitals Pvt Ltd

🇮🇳

Jaipur, Rajasthan, India

Maharaja Agrasen Superspeciality Hospital

🇮🇳

Jaipur, Rajasthan, India

Lisie Hospital

🇮🇳

Kochi, Kerala, India

Chula Field Hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium)

🇹🇭

Pathum Wan District,, Bangkok, Thailand

Bangkok Centre Hotel

🇹🇭

Bangrak, Bangkok, Thailand

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),

🇹🇭

Pathumwan, Bangkok, Thailand

Chronos Pesquisa Clinica

🇧🇷

Brasilia, Distrito Federal, Brazil

Thai Red Cross Emerging Infectious Diseases (EDI) Clinic

🇹🇭

Pathumwan,, Bangkok, Thailand

Jawahar Lal Nehru Medical College

🇮🇳

Ajmer, Rajasthan, India

Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,

🇹🇭

Hat Yai, Songkhla, Thailand

Instituto de Investigaciones Clinicas Zarate

🇦🇷

Zarate, Buenos Aires, Argentina

Aakash Healthcare Private Limited

🇮🇳

New Delhi, India

Sardar Patel Medical College

🇮🇳

Pavan PURI Bikaner, Rajasthan, India

Multiprofile Hospital For Active Treatment Shumen AD

🇧🇬

Shumen, Bulgaria

Hospital De Clínicas Presidente Dr.Nicolas Avellaneda

🇦🇷

San Miguel de Tucuman, Tucuman, Argentina

Agria-Study Kft.

🇭🇺

Eger, Hungary

Medifarma-98 Kft.

🇭🇺

Nyiregyhaza, Hungary

Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD

🇧🇬

Burgas, Bulgaria

"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd

🇧🇬

Haskovo, Bulgaria

MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD

🇧🇬

Kozloduy, Bulgaria

National Center for Global Health and Medicine

🇯🇵

Shinjuku City, Tokyo, Japan

Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska

🇵🇱

Wroclaw, Poland

Communal Enterprise "Hospital #1" of Zhytomyr City Council

🇺🇦

Zhytomyr, Ukraine

Lifepoint Research LLP

🇮🇳

Pune, Maharashtra, India

Rinku General Medical Center

🇯🇵

Izumisano, Osaka, Japan

Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analitical

🇺🇦

Lviv, Ukraine

Akdeniz Universitesi Hastanesi

🇹🇷

Antalya, Turkey

Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company

🇺🇦

Kyiv, Ukraine

Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company

🇺🇦

Kyiv, Ukraine

Atella Clinical Research LLC.

🇺🇸

La Palma, California, United States

Premium Medical Research Corp

🇺🇸

Miami, Florida, United States

C'A Research

🇺🇸

Miami, Florida, United States

Entrust Clinical Research

🇺🇸

Miami, Florida, United States

LCC Medical Research Institute, LLC

🇺🇸

Miami, Florida, United States

Global Health Clinical Trials Corp

🇺🇸

Miami, Florida, United States

South Florida Research Center, Inc.

🇺🇸

Miami, Florida, United States

Suncoast Research Group, LLC

🇺🇸

Miami, Florida, United States

I.V.A.M. Clinical & Investigational Center, LLC

🇺🇸

Miami, Florida, United States

ProLive Medical Research, Corp.

🇺🇸

Miami, Florida, United States

Reed Medical Research

🇺🇸

Miami, Florida, United States

Kendall South Medical Center

🇺🇸

Miami, Florida, United States

Clinical Site Partners, Inc d/b/a CSP Miami

🇺🇸

Miami, Florida, United States

Coral Research Clinic Corp

🇺🇸

Miami, Florida, United States

Santos Research Center, CORP

🇺🇸

Tampa, Florida, United States

Excel Clinical Research

🇺🇸

Las Vegas, Nevada, United States

Sun Research Institute

🇺🇸

San Antonio, Texas, United States

BFHC Research

🇺🇸

San Antonio, Texas, United States

Omega Research Orlando, LLC

🇺🇸

Orlando, Florida, United States

ARC Clinical Research at William Cannon

🇺🇸

Austin, Texas, United States

EME RED Hospitalaria

🇲🇽

Mérida, Yucatán, Mexico

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