NCT04561063

Brief Summary

This is a randomised, multi-center, open label, adaptive, exploratory trial to assess the efficacy of two different drug regimens in terms of preventing symptomatic COVID-19 disease in healthcare workers at high risk of exposure to SARS-CoV-2. The trial will compare two different experimental medication arms to the control arm comprising the use of standard personal protective equipment (PPE) with no additional pharmacological intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,950

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Dec 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 8, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

September 21, 2020

Last Update Submit

June 6, 2022

Conditions

Covid19SARS-CoV Infection

Keywords

NitazoxanideSofosbuvir/DaclatasvirCOVID-19SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • Number of SARS-CoV-2 infections

    Number of SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology.

    6 months

Secondary Outcomes (6)

  • Duration of symptoms

    6 months

  • Maximum score on WHO Ordinal Scale

    6 months

  • Time to onset of SARS-CoV-2 infection

    6 months

  • Number of symptomatic SARS-CoV-2 infections

    6 months

  • Number of asymptomatic SARS-CoV-2 infections

    6 months

  • +1 more secondary outcomes

Study Arms (3)

Arm A: No pharmacological intervention (PPE only)

NO INTERVENTION

No intervention

Arm B: Nitazoxanide (NTZ)

ACTIVE COMPARATOR

Nitozoxanide administered

Drug: Nitazoxanide

Arm C: Sofosbuvir/daclatasvir (SOF/DCV).

ACTIVE COMPARATOR

Sofosbuvir/daclatasvir administered

Drug: Sofosbuvir/Daclatasvir

Interventions

NitazoxanideDRUG

Nitozoxanide 1 tablet (500 mg) taken 12-hourly with food for the first week, followed by 2 tablets (1000 mg) taken 12-hourly with food thereafter. (Participants that fail to tolerated the 1000 mg 12-hourly dose may revert back to the lower dose.)

Arm B: Nitazoxanide (NTZ)
Sofosbuvir/DaclatasvirDRUG

Sofosbuvir/daclatasvir 400mg/60 mg sofosbuvir/daclatasvir fixed dose combination 1 tablet daily

Arm C: Sofosbuvir/daclatasvir (SOF/DCV).

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years of age, inclusive, at the time of signing the informed consent.
  • Willing and able to provide informed consent via an electronic process.
  • Healthcare worker employed at a participating institution that has been identified as high-risk for SARS-CoV-2 exposure (may include doctors, nurses, nurse aids, radiographers, physiotherapists, phlebotomists, technicians, porters, cleaners, laboratory or other personnel identified as being at high risk of exposure), CHW involved in the collection of samples for the identification of SARS-CoV-2 through PCR, and inner city inhabitants at high risk for SARS-CoV-2 exposure due to the nature of their work and frequent use of public transport (may include essential services employees such as fire fighters, law enforcement officers, grocery store employees; and non healthcare workers using public transport at least three times a week).
  • Women of reproductive potential must be using a highly effective method of contraception prior to enrolment or must be willing to start a method at enrolment and continue its use throughout the duration of the study.
  • Body weight ≥45 kg.
  • Access to reliable video conference, telephone, direct/text messaging, or other device permitting real-time, reliable information transfer.

You may not qualify if:

  • Pregnant or lactating women.
  • PCR and/or serology confirmed SARS-Cov-2 infection at screening.
  • Current symptoms of COVID-19 disease (including, but not limited to, fever or chills, cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia, or diarrhea).
  • Self-reported presence or history of any of the following conditions:
  • Chronic kidney disease (Stage IV or receiving dialysis)
  • Cirrhosis (Child-Pugh Class B or greater)
  • Porphyria cutanea tarda.
  • Currently on treatment for epilepsy or other seizure disorder.
  • Currently on treatment with a protease inhibitor-based antiretroviral regimen, or efavirenz, or on treatment with amiodarone, carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin,St. John's wort or any herbal products which may potentially decrease the concentration of the IMP.
  • Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms or similar compounds.
  • Current enrolment in another COVID-19 prevention trial.
  • History of alcohol abuse within the last 6 months.
  • Having history or have risk factors for brady-arrhythmias (those with undiagnosed cardiac conditions).
  • History of malignancies in the last 5 years, excluding in-situ or non-invasive malignancies.
  • Concurrent or recent (within 3 months) participation in other research with a compound likely to interfere with any of the investigational products.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, 2196, South Africa

Location

Sunnyside Office Park

Johannesburg, Gauteng, South Africa

Location

Related Publications (1)

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

    PMID: 34473343DERIVED

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory Syndrome

Interventions

nitazoxanideSofosbuvirdaclatasvir

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Simiso Sokhela

    Ezintsha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Divisional Director: Ezintsha

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 23, 2020

Study Start

December 8, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06

Locations

ZA(2)