Study of Oral Administration of Ribavirin and Nitazoxamide Versus Placebo in COVID-19

NCT04563208 | Completed Phase 2 DMC

• 1 other identifier: DUACT-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, randomized, double-blind, 2-arm, parallel-group study of DuACT in participants with clinical symptoms of COVID-19 that have begun within the past 72 hours prior to testing.

Conditions

Covid19; SARS-CoV Infection

Keywords

Ribavirin; Nitazoxanide; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Rate of decline in viral load

  Rate of decline in viral load over the 10 days after randomization between participants treated with RBV and NTZ for COVID-19 and placebo

  10 days

Secondary Outcomes (5)

• Time to resolution of viral load

  28 days

• Comparison of proportion of subjects who are asymptomatic and symptomatic

  10 days

• Rate of decline in viral load

  Days 3 and 6

• Change in modified NEWS-2

  28 days

• Proportion of subjects with treatment emergent adverse events

  28 days

Study Arms (2)

Arm A: Placebo

PLACEBO COMPARATOR

Placebo administered

Drug: Placebo

Arm B: Ribavirin/Nitazoxanide (RBV/NTZ)

ACTIVE COMPARATOR

Ribavirin/Nitazoxanide (RBV/NTZ) administered

Drug: DuACT

Interventions

Placebo DRUG

Placebo administered on Days 1-5

Arm A: Placebo

DuACT DRUG

Day1: RBV 600 mg BID and NTZ 500 mg BID Days 2-5: RBV 400 mg BID and NTZ 500 mg BID

Arm B: Ribavirin/Nitazoxanide (RBV/NTZ)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed a current EC approved informed consent form
• Male or female participants between 18 and 75 years of age, inclusive diagnosis of SARS-CoV-2 infection, with all of the following, with onset of any within the 72 hours prior to testing:
• Presence of fever at time of screening of ≥ 38.0°C (≥ 100.0°F) and/or
• Presence of at least one constitutional symptom associated with Covid-19 (e.g. headache, myalgia, malaise, or fatigue, rash, diarrhea, loss or alteration of taste/smell) of any severity, and/or
• Presence of at least one respiratory symptom (e.g. cough, chest tightness or sore throat) and/or
• Diagnosis of COVID-19 with a positive PCR in the past 48 hours

You may not qualify if:

• Pregnant or lactating females
• Critically ill with presence of one or more of the following signs:
• difficulty breathing or shortness of breath
• need for admission to a hospital or an intensive care unit,
• acute respiratory failure requiring intubation/mechanical ventilation,
• signs of shock including hypotension
• Oxygen saturation \< 92 %
• Any clinically significant screening laboratory results that are greater than 5 times the upper limit of normal.
• Estimated GFR \< 50 mL/min/1.73 m2 (calculated using either Modification of Diet in Renal Disease (MDRD) or Cockcroft Gualt
• Known genetic hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) or autoimmune hemolytic anemia
• Hemoglobin less than 10 gm/dL or hematocrit \< 30 %
• Retinal eye disease
• Known chronic kidney disease, stage - 5 or receiving dialysis
• Inability to tolerate oral medications
• Allergy or prior adverse reaction to either ribavirin or nitazoxanide

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead
• SynaVir: collaborator

Study Sites (1)

Sunnyside Office Park

Johannesburg, Gauteng, South Africa

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Simiso Sokhela

  Ezintsha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double-blind
• Purpose: TREATMENT
• 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 24, 2020
• Study Start: December 9, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

ZA (1)