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Anti-helminthic

Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (RESERVOIR Trial)

Phase 2
Waitlist Available
Research Sponsored by Entero Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 43

Summary

This trial is testing a treatment for adults who have COVID-19 and also suffer from gastrointestinal infections. The goal is to see if this treatment can help improve their condition.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 43 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fecal RNA Virus Clearance
SAEs
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Alkaline Phosphatase, AST, ALT, and LDH)
+8 more
Secondary study objectives
Clinical Severity Score
Time to Resolution of Diarrhea

Side effects data

From 2021 Phase 2 trial • 73 Patients • NCT04399356
21%
Nausea
9%
Skin rash
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Niclosamide- Experimental Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NiclosamideExperimental Treatment1 Intervention
Niclosamide tablets 400 mg 3 times daily for 14 days
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo tablets 3 times daily for 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niclosamide
2017
Completed Phase 3
~2280

Find a Location

Who is running the clinical trial?

Entero TherapeuticsLead Sponsor
9 Previous Clinical Trials
244 Total Patients Enrolled
First Wave Bio, Inc.Lead Sponsor
6 Previous Clinical Trials
108 Total Patients Enrolled
AzurRx BioPharma, Inc.Lead Sponsor
2 Previous Clinical Trials
68 Total Patients Enrolled
First Wave BioPharma, Inc.Lead Sponsor
6 Previous Clinical Trials
108 Total Patients Enrolled
~36 spots leftby Dec 2025
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