18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Respiratory Viral ClearancePrimary· Reduction in viral shedding as measured by oropharyngeal swab on days, 3, 7, 10, 14.
Respiratory viral clearance is defined as the first day a participant's oropharyngeal (oral) sample result is negative, provided that none of the subsequent oral sample results are positive. We will calculate the time to clearance since Day 1.
Group
Value
95% CI
Niclosamide- Experimental Group
3.39
1.88 – 4.91
Control Group
3.44
2.23 – 4.65
Time to Fecal Viral ClearanceSecondary· Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.
Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21. Fecal viral clearance is defined as the first day a participant's fecal sample result is negative, provided that none of the subsequent fecal sample results are positive; calculated as the time to clearance since Day 1.
Group
Value
95% CI
Niclosamide- Experimental Group
6.12
3.51 – 8.73
Control Group
5.77
3.3 – 8.23
Number of Participants With Progression to Severe COVID-19 DiseaseSecondary· Day 1- 30
Defined as 1) O2 saturation \<92% on room air (in two consecutive measurements at least 2 hours apart) OR 2) requirement of hospitalization OR 3) need for artificial ventilation OR 4) death. 1) We will compare the proportion of participants who progressed to severe COVID disease between groups.
Group
Value
95% CI
Niclosamide- Experimental Group
0
Control Group
1
Number of Days to Resolution of a FeverSecondary· Day 1-30
Mean time to fever resolution (symptom no longer reported).
Group
Value
95% CI
Niclosamide- Experimental Group
10.2
1.86 – 18.54
Control Group
3.6
2.07 – 5.13
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT04932915 — Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19
· Phase 2
· terminated
NCT04858425 — Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
· Phase 2
· terminated
NCT04870333 — PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V
· Phase 2, PHASE3
· completed
NCT04705415 — A Single and Multiple Ascending Dose Study of Niclosamide in Healthy Volunteers
· Phase 1
· completed
NCT04644705 — Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat
· Phase 1
· completed
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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· Phase 1
· active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
· Phase 3
· active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
· Phase 1
· recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
· Phase 2
· recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A
· Phase 3
· active not recruiting
Other Tufts Medical Center trials
Trials by the same sponsor.
NCT07386041 — Lung Ultrasound-Guided Respiratory Management in Infants
· NA
· not yet recruiting
NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis
· not yet recruiting
NCT07473713 — Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
· Phase 1
· recruiting
NCT07097168 — Using WHOOP Fitness Band to Measure Heart Health Variability Before and After Surgery
· withdrawn
NCT06384898 — Remote Tai Chi for Knee Osteoarthritis
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tufts Medical Center
Last refreshed: 12 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04399356.