search
Back to results

Niclosamide in COVID-19

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Niclosamide Oral Tablet
Placebo
Sponsored by
First Wave BioPharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Part 1 only: Patients hospitalized with a primary diagnosis of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge.

Part 2 only: Patients with a primary diagnosis of COVID-19 with or without pneumonia who are not planned to be hospitalized.

  • Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least solid-formed 3 stools per week and no more than 3 solid-formed stools per day.
  • SARS-CoV-2 RNA presence in rectal swab (or stool test) ≤2 days before randomization by local or central lab.
  • Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment

Exclusion Criteria:

  • At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.
  • Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Niclosamide

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mortality
    All-cause mortality
    TEAE
    Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation
    SAEs
    Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA)
    Safety laboratory
    Change in safety laboratory tests from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided
    Blood pressure
    Change in sitting systolic and diastolic blood pressure from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
    fecal RNA virus clearance
    time to fecal RNA virus clearance (rectal swab or stool sample) assessed by RT-qPCR in the niclosamide group, compared to the placebo group (Part 2 only)
    Body temperature
    Change in body temperature from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
    Heart rate
    Change in heart rate from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
    SaO2
    Change in SaO2 from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
    ECG
    Change in ECG parameters including: 1. PR interval 2. RR interval 3. QRS interval 4 QT interval 5. HR interval 6. QtcF interval. All intervals summarized descriptively by visit from baseline to 6 weeks

    Secondary Outcome Measures

    Full Information

    First Posted
    September 4, 2020
    Last Updated
    February 4, 2022
    Sponsor
    First Wave BioPharma, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04542434
    Brief Title
    Niclosamide in COVID-19
    Official Title
    A Phase 2 Randomized Double Blind, Placebo-controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor asset acquired by another pharma company who opened their own IND for this compound. First Wave Bio never started this study in the US or ex-US.
    Study Start Date
    January 20, 2022 (Actual)
    Primary Completion Date
    January 20, 2022 (Actual)
    Study Completion Date
    January 20, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Wave BioPharma, Inc.

    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 two-part, Phase 2, multicentre, randomized, double blind, 2-arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Covid19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Niclosamide
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Niclosamide Oral Tablet
    Intervention Description
    Niclosamide tablets 400 mg 3 times daily for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo tablets 3 times daily for 14 days
    Primary Outcome Measure Information:
    Title
    Mortality
    Description
    All-cause mortality
    Time Frame
    From Day 1 to 6 weeks
    Title
    TEAE
    Description
    Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation
    Time Frame
    From Day 1 to 6 weeks
    Title
    SAEs
    Description
    Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA)
    Time Frame
    From Day 1 to end of study
    Title
    Safety laboratory
    Description
    Change in safety laboratory tests from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided
    Time Frame
    From Day 1 to 6 weeks
    Title
    Blood pressure
    Description
    Change in sitting systolic and diastolic blood pressure from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
    Time Frame
    From Day 1 to 6 weeks
    Title
    fecal RNA virus clearance
    Description
    time to fecal RNA virus clearance (rectal swab or stool sample) assessed by RT-qPCR in the niclosamide group, compared to the placebo group (Part 2 only)
    Time Frame
    From Day 1 to 6 weeks
    Title
    Body temperature
    Description
    Change in body temperature from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
    Time Frame
    From Day 1 to 6 weeks
    Title
    Heart rate
    Description
    Change in heart rate from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
    Time Frame
    From Day 1 to 6 weeks
    Title
    SaO2
    Description
    Change in SaO2 from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
    Time Frame
    From Day 1 to 6 weeks
    Title
    ECG
    Description
    Change in ECG parameters including: 1. PR interval 2. RR interval 3. QRS interval 4 QT interval 5. HR interval 6. QtcF interval. All intervals summarized descriptively by visit from baseline to 6 weeks
    Time Frame
    From Day 1 to 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Part 1 only: Patients hospitalized with a primary diagnosis of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge. Part 2 only: Patients with a primary diagnosis of COVID-19 with or without pneumonia who are not planned to be hospitalized. Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least solid-formed 3 stools per week and no more than 3 solid-formed stools per day. SARS-CoV-2 RNA presence in rectal swab (or stool test) ≤2 days before randomization by local or central lab. Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment Exclusion Criteria: At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission. Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.

    12. IPD Sharing Statement

    Learn more about this trial

    Niclosamide in COVID-19

    We'll reach out to this number within 24 hrs