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Msg  1242 of 1930  at  7/2/2020 3:34:53 PM  by

Rob Cos

The following message was updated on 7/2/2020 4:01:37 PM.

ISI Fastest Growth & Double Time Past Week - 3 of top 8 Austin (St. David's South Austin Medical Center) , Jacksonville #1 (Mayo) & PHX (Mayo) are locations where BSGM Mayo Ph 2 is currently "Briskly Progressing"

  
  
 
Trial record 1 of 1 for: Viralclear | COVID
Previous Study | Return to List | Next Study

Study of Merimepodib in Combination With Remdesivir in Adult Patients With Advanced COVID-19


ClinicalTrials.gov Identifier: NCT04410354
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
ViralClear Pharmaceuticals, Inc.

Study Description
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Brief Summary:
The purpose of this study is to assess the safety and efficacy of merimepodib (MMPD) oral solution when administered in combination with remdesivir in adult patients with advanced COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19Drug: MerimepodibDrug: Matching PlaceboDrug: RemdesivirPhase 2

Detailed Description:

This phase 2 randomized, double-blind, placebo-controlled study will enroll approximately 40 adult patients with advanced coronavirus disease 2019 (COVID-19), who have a score of 3 or 4 on the National Institute of Allergy and Infectious Disease (NIAID) 8-point ordinal scale and at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion or symptoms of severe lower respiratory symptoms. Approximately 40 patients will be randomized 1:1 to receive oral administration of MMPD + remdesivir or placebo + mdesivir.

Study subjects will undergo screening evaluations prior to the first dose of study drug. Study drug treatment (MMPD or placebo) will continue for 10 days, unless the patient is discharged from the hospital before completing the 10-day randomized treatment period. Both treatment arms will also receive remdesivir per the Emergency Use Authorization labeling. Evaluations will be performed on Days 0-10 and every day thereafter until the subject no longer requires any form of respiratory support or they reach the last planned day of in-person study assessments and still require respiratory support. The final in-person study evaluations will be performed 4 weeks after completion of study drug (MMPD or placebo) treatment (Day 37). The final study evaluation will be a telephone call on Day 56.

Study Design
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Study Type :Interventional (Clinical Trial)
Estimated Enrollment :40 participants
Allocation:Randomized
Intervention Model:Parallel Assignment
Intervention Model Description:Eligible study subjects will be randomized 1:1 to receive oral administration of study drug or placebo. Both treatment arms will also receive remdesivir.
Masking:Triple (Participant, Care Provider, Investigator)
Masking Description:Pharmacy prepares medications that are coded
Primary Purpose:Treatment
Official Title:A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)
Actual Study Start Date :June 16, 2020
Estimated Primary Completion Date :July 2020
Estimated Study Completion Date :August 2020
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: MMPD + remdesivir
Study subjects will receive MMPD oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days).
Drug: Merimepodib
400 mg (total daily dose of 1200 mg) for 10 days
Other Name: VX-497

Drug: Remdesivir
200 mg loading dose on Day 0 followed by 100 mg daily dose for 4 days. If a subject does not demonstrate clinical improvement, 100 mg daily dose may be extended for up to 5 additional days (for a total of up to 10 days)

Placebo Comparator: Placebo + remdesivir
Study subjects will receive matching placebo oral solution 3 times per day for 10 days unless discontinued early. Study subjects will also receive remdesivir infusion once a day for 5 days. If a subject does not demonstrate clinical improvement, remdesivir treatment may be extended for up to 5 additional days (for a total of up to 10 days).
Drug: Matching Placebo
0 mg (total daily dose of 0 mg) for 10 days

Drug: Remdesivir
200 mg loading dose on Day 0 followed by 100 mg daily dose for 4 days. If a subject does not demonstrate clinical improvement, 100 mg daily dose may be extended for up to 5 additional days (for a total of up to 10 days)



Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects not hospitalized or, if hospitalized, free of respiratory failure [ Time Frame: Day 0 to Day 28 ]
    Proportion of subjects alive at Day 28 who are not hospitalized or if hospitalized are free of respiratory failure

  2. Adverse Events [ Time Frame: Day 0 to Day 56 ]
    Number of Adverse Events (AEs) and number & percentage of subjects experiencing AEs after administration of the first dose of study drug


Secondary Outcome Measures :
  1. National Institute of Allergy and Infectious Disease (NIAID) 8-Point Ordinal Scale [ Time Frame: Day 0 to Day 28 ]
    Change in NIAID 8-point ordinal scale, where 1=Death and 8=Not hospitalized, no limitations on activities

  2. Temperature [ Time Frame: Day 0 to Day 37 ]
    Duration of fever

  3. Death [ Time Frame: Day 0 to Day 56 ]
    Number of deaths

  4. Mechanical ventilation [ Time Frame: Day 0 to Day 56 ]
    Need and duration of mechanical ventilation

  5. Vasopressor Support [ Time Frame: Day 0 to Day 56 ]
    Duration of vasopressor support

  6. Oxygen Therapy [ Time Frame: Day 0 to Day 37 ]
    Duration of oxygen therapy via mechanical ventilation, face mask or nasal cannula

  7. Cessation of Viral Shedding [ Time Frame: Day 0 to Day 37 ]
    Time to cessation of viral shedding based on absence of SARS-CoV-2 in a PCR based COVID-19 test

  8. Change in Oxygen Saturation/Fraction of Inspired Oxygen [ Time Frame: Day 0 to Day 37 ]
    Change in SpO2/FiO2

Eligibility Criteria
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Information from the National Library of Medihoosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Confirmed SARS-CoV-2 viral infection
  • Advanced COVID-19 with score of 3 or 4 on NIAID scale
  • Has at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath, confusion or severe lower respiratory symptoms
  • Off antiviral medications at least 24 hours prior to first dose of study drug
  • Able to provide consent
  • Agree to appropriate methods of contraception

Exclusion Criteria:

  • In critical condition or has ARDS
  • On invasive mechanical ventilation or ECMO
  • Bacterial or fungal infection
  • Pregnant or lactating (women)
  • ALT >5x ULN, bilirubin >2x ULN, INR outside of normal limits at screening
  • eGFR <30 mL/min
  • Clinically relevant serious co-morbid medical conditions
  • Treatment with any immunosuppressive therapy within 30 days prior to screening
  • Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to screening
  • Prior treatment with the study drug (MMPD) or remdesivir
  • Known hypersensitivity to the inactive ingredients in the study drug (MMPD or placebo) or any ingredient of remdesivir
Contacts and Locations
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Contacts
Contact: Andrew Badley, MD507-266-1944badley.andrew@Mayo.edu

Locations
United States, Arizona
Mayo Clinic in ArizonaRecruiting
Phoenix, Arizona, United States, 85054
Contact: Study Coordinator
Principal Investigator: Robert Orenstein, DO
United States, Florida
Mayo Clinic in FloridaRecruiting
Jacksonville, Florida, United States, 32224
Contact: Study Coordinator
Principal Investigator: Claudia Libertin, MD
United States, Minnesota
Mayo ClinicRecruiting
Rochester, Minnesota, United States, 55905
Contact: Study Coordinator
Principal Investigator: Zelalem Temesgen, MD
United States, New Jersey
Atlantic Health System / Morristown Medical CenterRecruiting
Morristown, New Jersey, United States, 07960
Contact: Study Coordinator
Principal Investigator: Eric Whitman, MD
Atlantic Health System / Overlook Medical CenterRecruiting
Summit, New Jersey, United States, 07901
Contact: Study Coordinator
Principal Investigator: Eric Whitman, MD
United States, Texas
St. David's South Austin Medical CenterRecruiting
Austin, Texas, United States, 78704
Contact: Study Coordinator
Principal Investigator: Brian Metzger, MD
Sponsors and Collaborators
ViralClear Pharmaceuticals, Inc.
Investigators
Study Director:Andrew Badley, MDMayo Clinic
More Information
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Responsible Party:ViralClear Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:NCT04410354 History of Changes
Other Study ID Numbers:VC-02-01
First Posted:June 1, 2020 Key Record Dates
Last Update Posted:June 18, 2020
Last Verified:June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:No

Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
Keywords provided by ViralClear Pharmaceuticals, Inc.:
Coronavirus
Advanced Coronavirus Disease 2019
SARS-Cov-2
 
 


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