COVID-19Phase 2/3NCT04603924

Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients

A Phase 2/3 study testing Niclosamide in people with COVID-19, run by NeuroBo Pharmaceuticals Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study of ANA001 in Moderate and Severe COVID-19 Patients Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Niclosamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 8 sitesUnited States
Study dates: 7 Oct 2020to 16 Feb 2022
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Provide written informed consent prior to performing study procedures
Hospitalized.
Male or female ≥18 years of age
Positive for severe acute respiratory syndrome coronavirus 2
Presence of symptoms of lower respiratory tract infection (LRTI) including at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, or more significant lower respiratory tract symptoms, including shortness of breath
At least 1 of the following: respiratory rate (RR) ≥20 breaths per minute, room air oxygen saturation (SpO2) <98%, requirement for supplemental oxygen, heart rate (HR) ≥90 beats per minute, or temperature >38.3°C
Women of childbearing potential must agree to abstinent or use at least 1 form of contraception not including hormonal contraception from the day of screening through Day 30

Who cannot join

Hospitalized but no longer requires ongoing inpatient care (i.e., discharge is anticipated in ≤24 hours)
Patient is not anticipated to survive >48 hours OR is under palliative care
Evidence of critical illness, defined by at least 1 of the following:
Respiratory failure requiring at least 1 of the following:
Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula
Noninvasive positive pressure ventilation (NIPVV), OR

Show all 15Show fewer

Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure
Shock (defined by systolic blood pressure (BP) <90 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), OR
Multi-organ dysfunction/failure
Severe central nervous system (CNS) conditions
Chronic kidney disease requiring dialysis
Known allergy to the study drug or salicylate containing medications.
Suspected and/or confirmed pregnancy or breastfeeding
Current or planned participation in any other clinical trial of a treatment being developed under a US investigational new drug (IND) or emergency use authorization (EUA).
Patients receiving chemotherapeutic agents and/or immunomodulators (including monoclonal antibodies (Mabs) or plasma transfusions) for chronic disease conditions.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Missouri Health Care
Columbia, Missouri, 65212
Providence Regional Medical Center Everett
Everett, Washington, 92801
Caroline Institute for Clinical Research
Fayetteville, North Carolina, 28303
Memorial Hermann Memorial City Medical Center
Houston, Texas, 77024
University of California, Irvine
Irvine, California, 92697
Baptist Health Research Institute
Jacksonville, Florida, 32207
Helen Keller Hospital
Sheffield, Alabama, 35660
AdventHealth Tampa
Tampa, Florida, 33613

Other trials in United States

About this study

Official title: A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate and Severe COVID-19 Patients

Study of ANA001 in Moderate and Severe COVID-19 Patients

Read the detailed description

This is a 2 part, Phase 2/3 multi-center, double blinded, placebo-controlled study to assess the safety, tolerability, and efficacy of oral niclosamide (ANA001) in moderate and severe hospitalized COVID-19 patients compared to placebo.

Conditions: COVID-19
Being tested: Niclosamide, Placebo
Keywords: Corona Virus Disease (COVID-19), Niclosamide, Antiviral, Immunomodulator, Oral Niclosamide, Infection, Acute Respiratory Distress Syndrome (ARDS), Cytokine dysregulation, Virus, Viral, anthelmintic, anti-inflammatory, bronchodilator, antineoplastic, ANA001, Moderate COVID-19, ARDS, Acute Respiratory Distress Syndrome, Hospitalized COVID-19
Medical subject headings: COVID-19, Infections, Respiratory Distress Syndrome, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NiclosamideDrug
Also called ANA001
Niclosamide is an antihelmintic with in-vitro antiviral activity
PlaceboDrug
Also called Matching Placebo to ANA001
Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients

Study groups in NCT04603924
Study group	Role	What they receive
ANA001	Experimental	Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding. Receives: Drug: Niclosamide
Matching Placebo	Placebo comparator	Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Experiencing TEAEs
Incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: Randomization to Day 60
Number of Subjects Experiencing TESAEs
Incidence of Treatment Emergent Serious Adverse Events (TESAEs)
Measured: Randomization to Day 60

Secondary outcomes (7)

Median Time to Hospital Discharge
Median time until patient is discharged from hospital. Discharge is defined as a score of 1 or 2 in the WHO Ordinal Scale for Clinical Improvement. This is a 9 point ordinal scale with 0 indicating "No clinical or virological evidence of infection" and 8 indicating "Death".
Measured: Randomization to Day 60
Median Time to 2-point Improvement WHO Clinical Improvement Scale
Median Time to 2-point Improvement in WHO Ordinal Scale for Clinical Improvement. This is a 9 point ordinal scale with 0 indicating "No clinical or virological evidence of infection" and 8 indicating "Death"
Measured: Randomization to Day 60
Median Time to Resolution of COVID-19 Symptoms
Median time (in days) to resolution of subjective symptoms assessed by the Investigator to be potentially due to COVID-19 including: fever, cough (productive or non-productive), sore throat, malaise, headache, muscle pain, gastrointestinal symptoms (i.e., nausea, vomiting, or diarrhea), shortness of breath (with or without exertion), and respiratory distress
Measured: Randomization to Day 60
Median Time to Time-to-Viral Load Undetectable
Median number of days to viral load undetectable by nasopharyngeal (NP) swab
Measured: Randomization to Day 60
AUC 0-t (h*ng/mL)
Area under the drug concentration (h*ng/mL) (AUC) vs time curve on Days 1 and 2
Measured: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.
Cmax (ng/mL)
Maximum post dose plasma drug concentration on [Cmax (ng/mL)] Days 1 and 2
Measured: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.
Tmax (h)
Time to maximum post dose plasma drug concentration on [Tmax (h)] Days 1 and 2
Measured: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 202016 Feb 2022

First posted27 Oct 2020
Study start7 Oct 2020
Primary completion16 Feb 2022
Study completion16 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04603924
Sponsor's protocol ID: ANA001-001
Status last verified: Jan 2025
First submitted: 20 Oct 2020
Last updated: 15 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2/3 Randomized and Placebo-Controlled Study of ANA001 in Moderate and Severe COVID-19 Patients
ClinicalTrials.gov ID: NCT04603924
Acronym / sponsor ID: ANA001-001
Conditions: COVID-19
Keywords: Corona Virus Disease (COVID-19), Niclosamide, Antiviral, Immunomodulator, Oral Niclosamide, Infection, Acute Respiratory Distress Syndrome (ARDS), Cytokine dysregulation
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 7 Oct 2020 (actual)
Primary completion: 16 Feb 2022 (actual)
Study completion: 16 Feb 2022 (actual)
First posted: 27 Oct 2020 (actual)
Results: Posted 15 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study of ANA001 in Moderate and Severe COVID-19 Patients

Detailed description

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
ANA001	Experimental	Drug: NiclosamideSubjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Matching Placebo	Placebo comparator	Drug: PlaceboSubjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Provide written informed consent prior to performing study procedures
Hospitalized.
Male or female ≥18 years of age
Positive for severe acute respiratory syndrome coronavirus 2
Presence of symptoms of lower respiratory tract infection (LRTI) including at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, or more significant lower respiratory tract symptoms, including shortness of breath

Key exclusion criteria (15 listed)

Hospitalized but no longer requires ongoing inpatient care (i.e., discharge is anticipated in ≤24 hours)
Patient is not anticipated to survive >48 hours OR is under palliative care
Evidence of critical illness, defined by at least 1 of the following:
Severe central nervous system (CNS) conditions
Chronic kidney disease requiring dialysis

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
NiclosamideAlso: ANA001Niclosamide is an antihelmintic with in-vitro antiviral activity	Drug	ANA001
PlaceboAlso: Matching Placebo to ANA001Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients	Drug	Matching Placebo

Primary outcome

Number of Subjects Experiencing TEAEs
Time frame: Randomization to Day 60
Incidence of Treatment Emergent Adverse Events (TEAEs)
Number of Subjects Experiencing TESAEs
Time frame: Randomization to Day 60
Incidence of Treatment Emergent Serious Adverse Events (TESAEs)

7 secondary outcomes

Median Time to Hospital Discharge
Time frame: Randomization to Day 60
Median Time to 2-point Improvement WHO Clinical Improvement Scale
Time frame: Randomization to Day 60
Median Time to Resolution of COVID-19 Symptoms
Time frame: Randomization to Day 60
Median Time to Time-to-Viral Load Undetectable
Time frame: Randomization to Day 60
AUC 0-t (h*ng/mL)
Time frame: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.
Cmax (ng/mL)
Time frame: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.
Tmax (h)
Time frame: Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose.

Results and safety

Results posted to the registry on 15 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ANA001	25	15
Matching Placebo	24	15

Primary outcome: Number of Subjects Experiencing TEAEs

Time frame: Randomization to Day 60. Count of participants. Unit: Participants

Measure	ANA001 n = 22	Matching Placebo n = 23
No. of Subjects with any TEAE	16	12
No. of Subjects with Mild (Grade 1) TEAEs	9	2
No. of Subjects with Moderate (Grade 2) TEAEs	5	4
No. of Subjects with Severe (Grade 3) TEAEs	0	2
No. of Subjects with Life-Threatening (Grade 4) TEAEs	0	1
No. of Subjects with Death (Grade 5) TEAEs	2	3

Population analysed: Safety Analysis Set: Includes all randomized participants, classified according to the actual treatment received regardless of randomization assignment, who received any amount of study drug and have at least one post-baseline safety evaluation. This is the analysis population for all planned safety analyses.

Primary outcome: Number of Subjects Experiencing TESAEs

Time frame: Randomization to Day 60. Count of participants. Unit: Participants

Measure	ANA001 n = 22	Matching Placebo n = 23
Value	3	6

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ANA001	3 of 22 (13.6%)	16 of 22 (72.7%)	2 of 22
Matching Placebo	6 of 23 (26.1%)	12 of 23 (52.2%)	3 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Doug Rank, MD study director

NeuroBo Pharmaceuticals

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Niclosamide in people with COVID-19, run by NeuroBo Pharmaceuticals Inc. at 8 sites in United States.

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 7 inclusion and 15 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: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects Experiencing TEAEs (time frame: Randomization to Day 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04603924.

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 15 May 2025.