RESERVOIR: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

Sponsor
AzurRx BioPharma, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04858425
Collaborator
(none)
159
Enrollment
23
Locations
2
Arms
10
Anticipated Duration (Months)
6.9
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 2-Part, 2-Arm, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study on the Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
Actual Study Start Date :
Apr 30, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Niclosamide

Niclosamide tablets 400 mg 3 times daily for 14 days

Drug: Niclosamide
Niclosamide tablets 400 mg 3 times daily for 14 days

Placebo Comparator: Placebo

Matching placebo tablets 3 times daily for 14 days

Drug: Placebo
Matched placebo tablets 400 mg 3 times daily for 14 days

Outcome Measures

Primary Outcome Measures

  1. SAEs [Day 1 to 6 weeks]

    Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).

  2. TEAE [Day 1 to 6 weeks]

    Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation.

  3. Safety Laboratory Tests including CBC, BUN, blood sugar, electrolytes [Day 1 to Day 43]

    Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, 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.

  4. Fecal RNA virus Clearance [Day 1 to 6 weeks]

    Time to fecal viral RNA clearance (stool sample) assessed by RT-qPCR in the niclosamide arm compared to the placebo arm.

Secondary Outcome Measures

  1. Clinical Severity Score [Day 1 to 6 weeks]

    Proportion of patients with each clinical severity score as recommended by the World Health Organization (WHO) for COVID-19 studies by study visit;

  2. Time to Resolution of Diarrhea [Day 1 to 6 weeks]

    Time from the first dose of study treatment to the last loose or watery stool in patients with loose or watery stool (Bristol Stool Scale Types 5-7).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Part 1 only, patients with a primary diagnosis of COVID-19, with or without pneumonia, who agree to be monitored daily for at least 7 days after randomization and who accept continuing to be assessed for the study procedures.

  2. Part 2 only, patients with a primary diagnosis of COVID-19, with or without pneumonia.

Exclusion Criteria:
  1. At the time of randomization, patients who require intensive care unit (ICU) admission or patients with severe respiratory insufficiency who require mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.

  2. Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition that, in the opinion of the investigator, makes the patient unsuitable for inclusion.

  3. Patients who, at the time of enrollment, are not in a clinical condition compatible with the oral administration of the study drug.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Jasper Summit Research, LLCJasperAlabamaUnited States35501
2Physicians Research Group II, LLCTempeArizonaUnited States85284
3Synergy HealthcareBradentonFloridaUnited States34208-1004
4Midland Florida Clinical Research Center, LLCDeLandFloridaUnited States32720-0920
5Lakes ResearchMiami LakesFloridaUnited States33014-2476
6LCC Medical Reserach Institute, LLCMiamiFloridaUnited States33126
7Miami Clinical ResearchMiamiFloridaUnited States33155
8P & S Research, LLCMiamiFloridaUnited States33175-2912
9Snake River Research, PLLCIdaho FallsIdahoUnited States83404
10SMS Clinical Research LLCMesquiteTexasUnited States75149
11Tranquil ResearchWebsterTexasUnited States77598
12Yashoda HospitalSecunderabadAndhra PradeshIndia50003
13SSG Hospital and Medical InstituteVadodaraGujaratIndia390001
14GMERS Medical College and HospitalVadodaraGujaratIndia390021
15Noble Hospital Private LimitedPuneMaharashtraIndia411013
16Sir Ganga Ram HospitalNagarNew DelhiIndia110060
17Maharaja Agrasen Superspeciality Hospital, JaipurJaipurRajasthanIndia302039
18Malla Reddy Narayana Multispecialty HospitalHyderabadTelanganaIndia500055
19Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska"KremenchugPoltavaUkraine39600
20Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City CouncilDniproUkraine41102
21Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City CouncilIvano-FrankivskUkraine76025
22Municipal Non-Profit Enterprise City Clinical Hospital 13 of Kharkiv Regional CouncilKharkivUkraine61124
23Private Enterprise Private Manufacturing Company AcinusKropyvnytskyiUkraine25006

Sponsors and Collaborators

  • AzurRx BioPharma, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AzurRx BioPharma, Inc.
ClinicalTrials.gov Identifier:
NCT04858425
Other Study ID Numbers:
  • AZ-NICL-COV-1
First Posted:
Apr 26, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AzurRx BioPharma, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021