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Niclosamide in COVID-19

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ClinicalTrials.gov Identifier: NCT04542434
Recruitment Status : Not yet recruiting
First Posted : September 9, 2020
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
First Wave Bio, Inc.

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

Condition or disease Intervention/treatment Phase
Covid19 Drug: Niclosamide Oral Tablet Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized Double Blind, Placebo-controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Niclosamide Drug: Niclosamide Oral Tablet
Niclosamide tablets 400 mg 3 times daily for 14 days

Placebo Comparator: Placebo Drug: Placebo
Matching placebo tablets 3 times daily for 14 days




Primary Outcome Measures :
  1. Mortality [ Time Frame: From Day 1 to 6 weeks ]
    All-cause mortality

  2. TEAE [ Time Frame: From Day 1 to 6 weeks ]
    Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation

  3. SAEs [ Time Frame: From Day 1 to end of study ]
    Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA)

  4. Safety laboratory [ Time Frame: From Day 1 to 6 weeks ]
    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

  5. Blood pressure [ Time Frame: From Day 1 to 6 weeks ]
    Change in sitting systolic and diastolic blood pressure from baseline to 6 weeks summarized descriptively by visit and presented as shift tables

  6. fecal RNA virus clearance [ Time Frame: From Day 1 to 6 weeks ]
    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)

  7. Body temperature [ Time Frame: From Day 1 to 6 weeks ]
    Change in body temperature from baseline to 6 weeks summarized descriptively by visit and presented as shift tables

  8. Heart rate [ Time Frame: From Day 1 to 6 weeks ]
    Change in heart rate from baseline to 6 weeks summarized descriptively by visit and presented as shift tables

  9. SaO2 [ Time Frame: From Day 1 to 6 weeks ]
    Change in SaO2 from baseline to 6 weeks summarized descriptively by visit and presented as shift tables

  10. ECG [ Time Frame: From Day 1 to 6 weeks ]
    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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542434


Contacts
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Contact: Tony Opipari, M.D. 734-546-0228 tony@firstwavebio.com

Sponsors and Collaborators
First Wave Bio, Inc.
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Responsible Party: First Wave Bio, Inc.
ClinicalTrials.gov Identifier: NCT04542434    
Other Study ID Numbers: FW-COV-003
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Niclosamide
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents