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Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™ UPPTA for Patients With Early COVID-19

Primary Purpose

Coronavirus Disease 2019

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pentarlandir™ UPPTA
Placebo
Sponsored by
SyneuRx International (Taiwan) Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Disease 2019 focused on measuring COVID-19, Pentarlandir™ UPPTA, UPPTA

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women 18 years of age or older.
  2. Able and willing to provide informed consent.
  3. Able and willing to sufficiently operate smart phones and study-provided monitoring devices per the Investigator.
  4. Early COVID-19 diagnosis with mild severity defined as meeting all of the below:

    1. Confirmation of COVID-19 by a PCR-based diagnostic within 4 days of randomization.

      • COVID-19 with mild symptoms, defined as a score of 8 or higher on the clinical symptom score.
      • Clinical symptom score includes 9 items in fever or chills, myalgia, cough, headache, sore throat, new loss of test or smell, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), congestion or running nose, and fatigue (malaise) as assessed and recorded by the investigator.

      Note: The total score per patient ranges from 0 to 27 points. Each symptom is rated from 0 to 3. [0 = none, 1 = mild, 2 = moderate, and 3 = severe]

    2. No signs of a more serious lower airway disease per clinical exam, chest X-ray or chest CT.
    3. Resting RR ≤ 20, HR ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air.
  5. For women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause]):

    1. Negative urine pregnancy test at screening.
    2. Willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomize partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the last dose of study medication.
  6. Ability and willingness to comply with all aspects of the study through the entire study period.

Exclusion Criteria:

  1. Patient is either asymptomatic or with baseline severity of moderate, sever, or critical COVID-19.
  2. Pregnant or lactating women.
  3. Patients with shortness of breath at rest.
  4. Findings on physical examination or available imaging studies suggesting rapid disease progression of COVID-19.
  5. Signs or symptoms indicative of pneumonia or any other lower respiratory tract disorders, or clinically significant findings in available lung imaging studies suggestive of such disorders.
  6. Need for immediate hospitalization, oxygen supplementation or mechanical ventilation.
  7. Obstructive airway diseases, including chronic obstructive pulmonary disease (COPD) and asthma, or other respiratory disease that could exacerbate independent of COVID-19.
  8. Use of remdesivir, chloroquine, hydroxychloroquine, convalescent plasma, other monoclonal antibody therapies, include REGEN-COV (casirivimab and imdevimab), bamlanivimab (plus etesevimab), dexamethasone, ivermectin, baricitinib, and other Janus kinase inhibitors, Bruton's tyrosine kinase inhibitors, tocilizumab (and other interleukin-6 inhibitors) and any other therapy with EUA or approval and other investigational agents for COVID-19.
  9. Patients who are participating in other clinical trials.
  10. History of conditions associated with immunocompromise, or treatments known to affect the immune system, including but not limited to oral or intravenous corticosteroids, alkylating drugs, antimetabolites, cytotoxic drugs, other chemotherapy, radiation, immune-modulating biologics, within 30 days of screening.
  11. Barium enemas within the last 30 days.
  12. Taking OTC or prescribed medicine which has compound as active ingredient.
  13. Any unstable or uncontrolled medical illnesses such as neurological disorders, cardiovascular disorders, diabetes, hepatic or renal disorders that per the Investigator would intervene with the study conduct or study results interpretation.
  14. Any other medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety, or a patient's ability to give informed consent or respond to the study procedures or questions during the personal visits or the video calls.
  15. High-risk individuals are those who meet at least one of the following criteria:

    1. Aged ≥ 65 years
    2. Body mass index (BMI) > 30
    3. Pregnancy
    4. Chronic kidney disease
    5. Diabetes
    6. Immunosuppressive disease or immunosuppressive treatment
    7. Cardiovascular disease (including congenital heart disease) or hypertension
    8. Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
    9. Sickle cell disease
    10. Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
    11. Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19]
    12. Exclusion is not limited to the medical conditions or factors listed above. The investigators have to consider the benefit-risk for an individual patient to determine other medical conditions or factors (for example, overweight, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and be excluded.

Sites / Locations

  • Cullman Clinical TrialsRecruiting
  • Cactus Clinical Research, Inc.Recruiting
  • Synergy HealthcareRecruiting
  • Columbus Clinical ServicesRecruiting
  • C'A Research, LLCRecruiting
  • CTMD ResearchRecruiting
  • Eminat Research GroupRecruiting
  • Elite Medical ResearchRecruiting
  • Diversified Medical PracticesRecruiting
  • Accurate Clinical ResearchRecruiting
  • 1960 Family PracticeRecruiting
  • Ayinde Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Pentarlandir™ UPPTA - High Dose

Pentarlandir™ UPPTA - Low Dose

Placebo

Arm Description

High dose of Pentarlandir™ UPPTA, q8h (over 3 hours postprandially)

Low dose of Pentarlandir™ UPPTA and placebo, q8h (over 3 hours postprandially)

Pacebo, q8h (over 3 hours postprandially)

Outcomes

Primary Outcome Measures

Change from baseline in viral genome up to Day 14

Secondary Outcome Measures

Pharmacokinetics: Mean Concentration of Pentarlandir™ UPPTA on Days 3, 7, 10, 14.
Change from baseline in daily COVID-19-related symptom severity score through Day 28
A set of common COVID-19-related symptoms (see patient diary template for electronic Patient Report Outcome (ePRO)) will be evaluated daily by the patient regardless of which symptoms he/she had at baseline, as new symptoms may appear following the baseline assessment. (A Likert symptom scale will be developed using the (The 24 items reported in the ePRO, with potentially each item being normalized to 0 to 3 and the total score ranging from ranged 0 to 72))
Number of days with substantial COVID-19-associated symptoms from start of study treatment (Day 1) based on self-assessment using daily symptom diary.
Substantial COVID-19-associated symptom days are defined as number of days when any symptoms score as moderate or sever in ePRO through Day 28
Number of days without COVID-19-associated symptoms in ePRO from Day 1-28 based on self- assessment using daily ePRO symptom diary.
Symptom-free days are defined as number of days when all the symptoms score as absent (or none) in ePRO through Day 28.
Number of days with limited COVID-19-associated symptoms in ePRO from Day 1-28 based on self- assessment using daily ePRO symptom diary.
Days with limited COVID-19-associated symptoms are defined as number of days when up to two symptoms score as mild or absent while the rest score as absent (or none) in ePRO through Day 28.
Number of days with progression (or worsening) of COVID-19-associated symptoms in ePRO through Day 28 compared to baseline.
Progression or symptom worsening is defined as number of days when any symptoms scored as: moderate at baseline but score as severe on any day through Day28. mild at baseline but score as moderate or severe on any day through Day 28. absent at baseline but score as mild, moderate or worse on any day through Day 28.
Time to resolution, where resolution is defined as when a subject has scored absent (or none) on all COVID-19-associated symptoms for two consecutive days
Patient-reported global impression in ePRO
Patient-reported global impression in ePRO includes the following "In general, would you say that your health is excellent, very good, fair, or poor?" (The scores will be ranged between 1-5; excellent to poor)
Change from baseline in the patient's health status on a 7-category ordinal scale at up to Day 14
A 7-category ordinal scale of patient health status ranges from 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Change from baseline in pulse oxygen saturation up to Day 14

Full Information

First Posted
June 1, 2021
Last Updated
December 16, 2021
Sponsor
SyneuRx International (Taiwan) Corp
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1. Study Identification

Unique Protocol Identification Number
NCT04911777
Brief Title
Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™ UPPTA for Patients With Early COVID-19
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Proof of Principle Study of Pentarlandir™ UPPTA for the Treatment of Patients With Early COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SyneuRx International (Taiwan) Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a clinical trial to evaluate the safety, PK, viral shedding and clinical effects of Pentarlandir™ UPPTA in patients with early COVID-19. Approximately 90 ambulatory subjects with mildly symptomatic early COVID-19, who have been diagnosed with COVID-19 within the prior 4 days will be enrolled.
Detailed Description
This is a clinical trial to evaluate the safety, PK, viral shedding and efficacy of PentarlandirTM UPPTA as a treatment for patients with early COVID-19. Approximately 90 ambulatory subjects with mildly symptomatic early COVID-19, who have been diagnosed with COVID-19 within the prior 48 hours, will be enrolled in the proof of principle study. Upon signing informed consent and evaluating medical history, concomitant medications, oxygen saturation (SaO2) at room air and vital signs, a focused physical examination of the heart and lungs will be performed. Subjects will be randomized into High-Dose, Low-Dose, and Placebo group in a 1:1:1 ratio at the final sample, but the enrollment will be staggered. In the first phase, 45 study subjects will be randomized at 2:1 ratio to Pentarlandir™ UPPTA low dose or placebo. After all the forty-five (45) subjects have completed the Day 21 assessment or early terminated (14-day dosing and 7 days of followed-up), DSMB will review the safety from the cohort and provide concurrence with proceeding with the higher dose cohort. If DSMB deems that the study is safe to proceed, another 45 subjects will be randomized at 2:1 ratio to Pentarlandir™ UPPTA high dose or placebo in the second phase. Both staggered cohorts will have the same stopping rules. During both phases of study, specimens for quantification of the viral genome, inflammatory markers, and safety laboratory tests will be collected. The IP will be dispensed to the study subjects and the subject will take the first dose of the study treatment at the clinic. Study subjects will be instructed (and provided) to use a device for ePRO for how to complete the patient-reported diary. The subjects will take the IP orally. Subjects in the low-dose group will take from each bottle of the active drug and placebo every 8 hours (q8h); for the high-dose group, from each of the two bottles of active drug; and for the placebo group, from each of the two bottles of placebo for 14 days. The first treatment dose should be taken within 4 days of COVID-19 diagnosis. Physical examination, specimen collection, laboratory evaluations and urine pregnancy test, vital signs, pulse oxygen saturation and clinical symptom and status determination will be conducted. Subjects who meet the eligibility criteria will be randomized. All subjects who fail to meet eligibility criteria are considered screen failures and are exited from the study without further evaluation. Screening and Randomization (V1, Day 1): After determining the eligibility, the study subjects will be randomized 2:1 to Pentarlandir™ UPPTA (either low or high dose) or placebo. The IP for treatment period will be dispensed to the study subjects and the subject will take the first dose of the study treatment at the study site. Study subjects will be instructed (and provided) how to complete the electronic patient reported outcome (ePRO) on a device. Treatment Period (V2 - V14 (EOT), Day 2 - Day 14): The subjects will continue to document the daily diary of ePRO. Total 13 visits are included in this period. Except 4 in-persons visits (V3, V7, V10, and V14), no in-person visit is expected during the study. Subjects will return to the clinical study sites to collect specimens for quantification of viral genome, inflammatory markers, pharmacokinetic and safety laboratory tests as well as record the SaO2, oral temperature, heart and respiratory rate, blood pressure, symptoms and concomitant medications, to document clinical status and adverse events (AEs), and IP accountability will be monitored. In addition, clinical symptom assessments and 7-category ordinal scale will be evaluated as well along with safety laboratory evaluations to determine whether the subject will continue to take the IP or stop the clinical trial. The subject will return the study treatment bottles at EOT visit. Except for the in-person visits, subjects will be phone-called once every day between 8:00 AM and 7:00 PM on the visits to record concomitant medications and to document clinical status and 7-category ordinal scale as well as adverse events (AEs) to determine whether the subject will be taken of the IP and/or stop the clinical trial. Weekly Follow-Up Period (V15 - V20, Day 15 - Day 56): Between Day 15 to 28, subjects will perform the ePRO diary daily. In addition to ePRO, study subjects will be called every 7±2 days after EOT visit to document final outcome and AEs up to Day 56. AE/SAEs, hospital and ICU lengths of stays, and mortality in hospitalized subjects will be documented.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease 2019
Keywords
COVID-19, Pentarlandir™ UPPTA, UPPTA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
In the first phase, 45 subjects will be randomized at 2:1 ratio to Pentarlandir™ UPPTA low dose or placebo. After interim analysis and evaluate by DSMB, 45 subjects will be randomized to 2:1 ratio to Pentarlandir™ UPPTA high dose or placebo in second phase. The final sample will be high-dose, low-dose, and placebo group at 1:1:1 ratio.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pentarlandir™ UPPTA - High Dose
Arm Type
Experimental
Arm Description
High dose of Pentarlandir™ UPPTA, q8h (over 3 hours postprandially)
Arm Title
Pentarlandir™ UPPTA - Low Dose
Arm Type
Experimental
Arm Description
Low dose of Pentarlandir™ UPPTA and placebo, q8h (over 3 hours postprandially)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Pacebo, q8h (over 3 hours postprandially)
Intervention Type
Drug
Intervention Name(s)
Pentarlandir™ UPPTA
Intervention Description
Pentarlandir™ UPPTA is a white oral capsule (with 188 mg of UPPTA)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo of Pentarlandir™ UPPTA is a white oral capsule (without UPPTA)
Primary Outcome Measure Information:
Title
Change from baseline in viral genome up to Day 14
Time Frame
Baseline and Day14
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Mean Concentration of Pentarlandir™ UPPTA on Days 3, 7, 10, 14.
Time Frame
Day 3, 7, 10, and 14
Title
Change from baseline in daily COVID-19-related symptom severity score through Day 28
Description
A set of common COVID-19-related symptoms (see patient diary template for electronic Patient Report Outcome (ePRO)) will be evaluated daily by the patient regardless of which symptoms he/she had at baseline, as new symptoms may appear following the baseline assessment. (A Likert symptom scale will be developed using the (The 24 items reported in the ePRO, with potentially each item being normalized to 0 to 3 and the total score ranging from ranged 0 to 72))
Time Frame
Baseline to Day 28
Title
Number of days with substantial COVID-19-associated symptoms from start of study treatment (Day 1) based on self-assessment using daily symptom diary.
Description
Substantial COVID-19-associated symptom days are defined as number of days when any symptoms score as moderate or sever in ePRO through Day 28
Time Frame
28 days
Title
Number of days without COVID-19-associated symptoms in ePRO from Day 1-28 based on self- assessment using daily ePRO symptom diary.
Description
Symptom-free days are defined as number of days when all the symptoms score as absent (or none) in ePRO through Day 28.
Time Frame
28 days
Title
Number of days with limited COVID-19-associated symptoms in ePRO from Day 1-28 based on self- assessment using daily ePRO symptom diary.
Description
Days with limited COVID-19-associated symptoms are defined as number of days when up to two symptoms score as mild or absent while the rest score as absent (or none) in ePRO through Day 28.
Time Frame
28 days
Title
Number of days with progression (or worsening) of COVID-19-associated symptoms in ePRO through Day 28 compared to baseline.
Description
Progression or symptom worsening is defined as number of days when any symptoms scored as: moderate at baseline but score as severe on any day through Day28. mild at baseline but score as moderate or severe on any day through Day 28. absent at baseline but score as mild, moderate or worse on any day through Day 28.
Time Frame
Baseline to Day 28
Title
Time to resolution, where resolution is defined as when a subject has scored absent (or none) on all COVID-19-associated symptoms for two consecutive days
Time Frame
28 days
Title
Patient-reported global impression in ePRO
Description
Patient-reported global impression in ePRO includes the following "In general, would you say that your health is excellent, very good, fair, or poor?" (The scores will be ranged between 1-5; excellent to poor)
Time Frame
28 days
Title
Change from baseline in the patient's health status on a 7-category ordinal scale at up to Day 14
Description
A 7-category ordinal scale of patient health status ranges from 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Time Frame
Baseline to Day 14
Title
Change from baseline in pulse oxygen saturation up to Day 14
Time Frame
Baseline to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18 years of age or older. Able and willing to provide informed consent. Able and willing to sufficiently operate smart phones and study-provided monitoring devices per the Investigator. Early COVID-19 diagnosis with mild severity defined as meeting all of the below: Confirmation of COVID-19 by a PCR-based diagnostic within 4 days of randomization. COVID-19 with mild symptoms, defined as a score of 8 or higher on the clinical symptom score. Clinical symptom score includes 9 items in fever or chills, myalgia, cough, headache, sore throat, new loss of test or smell, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), congestion or running nose, and fatigue (malaise) as assessed and recorded by the investigator. Note: The total score per patient ranges from 0 to 27 points. Each symptom is rated from 0 to 3. [0 = none, 1 = mild, 2 = moderate, and 3 = severe] No signs of a more serious lower airway disease per clinical exam, chest X-ray or chest CT. Resting RR ≤ 20, HR ≤ 90, oxygen saturation (pulse oximetry) ≥ 95% on room air. For women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause]): Negative urine pregnancy test at screening. Willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomize partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (e.g., condom, diaphragm) with spermicide for 28 days after the last dose of study medication. Ability and willingness to comply with all aspects of the study through the entire study period. Exclusion Criteria: Patient is either asymptomatic or with baseline severity of moderate, sever, or critical COVID-19. Pregnant or lactating women. Patients with shortness of breath at rest. Findings on physical examination or available imaging studies suggesting rapid disease progression of COVID-19. Signs or symptoms indicative of pneumonia or any other lower respiratory tract disorders, or clinically significant findings in available lung imaging studies suggestive of such disorders. Need for immediate hospitalization, oxygen supplementation or mechanical ventilation. Obstructive airway diseases, including chronic obstructive pulmonary disease (COPD) and asthma, or other respiratory disease that could exacerbate independent of COVID-19. Use of remdesivir, chloroquine, hydroxychloroquine, convalescent plasma, other monoclonal antibody therapies, include REGEN-COV (casirivimab and imdevimab), bamlanivimab (plus etesevimab), dexamethasone, ivermectin, baricitinib, and other Janus kinase inhibitors, Bruton's tyrosine kinase inhibitors, tocilizumab (and other interleukin-6 inhibitors) and any other therapy with EUA or approval and other investigational agents for COVID-19. Patients who are participating in other clinical trials. History of conditions associated with immunocompromise, or treatments known to affect the immune system, including but not limited to oral or intravenous corticosteroids, alkylating drugs, antimetabolites, cytotoxic drugs, other chemotherapy, radiation, immune-modulating biologics, within 30 days of screening. Barium enemas within the last 30 days. Taking OTC or prescribed medicine which has compound as active ingredient. Any unstable or uncontrolled medical illnesses such as neurological disorders, cardiovascular disorders, diabetes, hepatic or renal disorders that per the Investigator would intervene with the study conduct or study results interpretation. Any other medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety, or a patient's ability to give informed consent or respond to the study procedures or questions during the personal visits or the video calls. High-risk individuals are those who meet at least one of the following criteria: Aged ≥ 65 years Body mass index (BMI) > 30 Pregnancy Chronic kidney disease Diabetes Immunosuppressive disease or immunosuppressive treatment Cardiovascular disease (including congenital heart disease) or hypertension Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension) Sickle cell disease Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies) Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19] Exclusion is not limited to the medical conditions or factors listed above. The investigators have to consider the benefit-risk for an individual patient to determine other medical conditions or factors (for example, overweight, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emil Tsai, MD, PhD
Phone
+1-818-696-8800
Email
emil.tsai@syneurx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sheena Koons
Email
sheena.koons@prevailinfoworks.com
Facility Information:
Facility Name
Cullman Clinical Trials
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl Hargrove
Phone
256-303-3071
Email
cheryl@cullmanclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
Jana Swindle
Phone
256-339-3137
Email
jana@cullmanclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
Justin Wilson, CRNP
Facility Name
Cactus Clinical Research, Inc.
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Almaraz
Phone
602-370-4691
Email
ralmaraz@cactusclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Anthony A Aghenta, MD
Facility Name
Synergy Healthcare
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Mora
Phone
941-896-4948
Email
lmora@synergyhealthcorp.com
First Name & Middle Initial & Last Name & Degree
Patrick Weston, MD
Facility Name
Columbus Clinical Services
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Llerena
Phone
305-631-6991
Email
sara.llerena@columbusclinical.net
First Name & Middle Initial & Last Name & Degree
Bertha Cano
Phone
305-631-6991
Email
b.cano@columbusclinical.net
First Name & Middle Initial & Last Name & Degree
Sara Llerena, MD
Facility Name
C'A Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Llobet
Phone
786-542-6933
Email
caresearch.llobet@gmail.com
First Name & Middle Initial & Last Name & Degree
Giralt Yanez, MD
Facility Name
CTMD Research
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doris Rodriguez
Phone
561-408-0613
Email
DRODRIGUEZ@CTMDRESEARCH.COM
First Name & Middle Initial & Last Name & Degree
Martha Alcantara
Phone
5614696704
Email
MALCANTARA@CTMDRESEARCH.COM
First Name & Middle Initial & Last Name & Degree
Luis Castillo, MD
Facility Name
Eminat Research Group
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Perez, MD
Facility Name
Elite Medical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanney Musa
Phone
682-367-5187
Email
hmusa@medct.net
First Name & Middle Initial & Last Name & Degree
Kaothar Hashim
Phone
4694900832
Email
khashim@medct.net
First Name & Middle Initial & Last Name & Degree
Gustavo Day, MD
Facility Name
Diversified Medical Practices
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Rodriguez
Phone
832-229-2622
Email
denise@biopharmainfo.net
First Name & Middle Initial & Last Name & Degree
Patricia D Salvato, MD
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Batista
Phone
713-377-6433
Email
abatista@accurateclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Adianez Diaz
Phone
7133776433
Email
adiaz@accurateclinicalmanagement.com
First Name & Middle Initial & Last Name & Degree
Aramis Cosme, MD
Facility Name
1960 Family Practice
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Mouton
Phone
281-501-5658
Email
alice@biopharmainfo.net
First Name & Middle Initial & Last Name & Degree
Gambo Dangwaran
Phone
2815015658
Email
gambo@biopharmainfo.net
First Name & Middle Initial & Last Name & Degree
Victor I Escobar, MD
Facility Name
Ayinde Clinical Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75038
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udeme Ebong
Phone
469-248-6362
Email
uebong@medct.net
First Name & Middle Initial & Last Name & Degree
Adila Siddiqi, Doctor

12. IPD Sharing Statement

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Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™ UPPTA for Patients With Early COVID-19

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