Covid19Phase 2NCT04542434
Niclosamide in COVID-19
A Phase 2 study testing Niclosamide Oral Tablet in people with Covid19, run by Entero Therapeutics.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Niclosamide Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2022to 20 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: A Phase 2 Randomized Double Blind, Placebo-controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19
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
- Conditions
- Covid19
- Being tested
- Niclosamide Oral Tablet, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niclosamide Oral TabletDrug
Niclosamide tablets 400 mg 3 times daily for 14 days
PlaceboDrug
Matching placebo tablets 3 times daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Niclosamide | Experimental | Not described Receives: Drug: Niclosamide Oral Tablet |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality
Measured: From Day 1 to 6 weeks
TEAE
Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation
Measured: From Day 1 to 6 weeks
SAEs
Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA)
Measured: From Day 1 to end of study
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
Measured: From Day 1 to 6 weeks
Blood pressure
Change in sitting systolic and diastolic blood pressure from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
Measured: From Day 1 to 6 weeks
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)
Measured: From Day 1 to 6 weeks
Body temperature
Change in body temperature from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
Measured: From Day 1 to 6 weeks
Heart rate
Change in heart rate from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
Measured: From Day 1 to 6 weeks
SaO2
Change in SaO2 from baseline to 6 weeks summarized descriptively by visit and presented as shift tables
Measured: From Day 1 to 6 weeks
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
Measured: From Day 1 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start20 Jan 2022
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542434
- Sponsor's protocol ID
- FW-COV-003
- Status last verified
- Dec 2021
- First submitted
- 4 Sep 2020
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Double Blind, Placebo-controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04542434
- Acronym / sponsor ID
- FW-COV-003
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Entero TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Niclosamide | Experimental | Drug: Niclosamide Oral Tablet |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niclosamide Oral TabletNiclosamide tablets 400 mg 3 times daily for 14 days | Drug | Niclosamide |
| PlaceboMatching placebo tablets 3 times daily for 14 days | Drug | Placebo |
Primary outcome
Mortality
Time frame: From Day 1 to 6 weeks
All-cause mortality
TEAE
Time frame: From Day 1 to 6 weeks
Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation
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)
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
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
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)
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
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niclosamide Oral Tablet in people with Covid19, run by Entero Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From Day 1 to 6 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.