Clinical Trial With N-acetylcysteine and Bromhexine for COVID-19

NCT04928495 | Unknown Phase 3 DMC

• 1 other identifier: AVANTI-C19
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical, control, double-blind, randomized experimentation with N-acetylcysteine and bromhexine for COVID-19.

Conditions

COVID-19

Keywords

N-acetylcysteine; Bromhexine; COVID-19; Clinical trial

Outcome Measures

Primary Outcomes (1)

• The time to recovery, defined at day 7 days follow up after enrollment, on which a patient met the criteria for category 1 or 2 on the four-category ordinal scale. [Time Frame: Day 7 follow up after enrollment.]

  The categories are as follows: 1 - No signals and symptoms; 2 - One signal or symptom; 3 - Two signals or symptoms; 4 - Three or more signals or symptoms.

  Day 7

Secondary Outcomes (3)

• SARS-CoV-2 RNA viral load measurements change. [ Time Frame: Change between Day 1 and Day 7 follow up after enrollment. ]

  Day 1 and Day 7

• Proportion of patients with qualitative serum IgM / IgG. [ Time Frame: Proportion of positive patients at Day 7 for IgM / IgG (N; %). ]

  Day 7

• Biomarkers (IL-6, MCP-3, D-dimer, IL1-RA, IL-10, GCSF, TNF-α, MCP-1, IL-2R, MIP-1 alpha, IP-10, IL-8, NT-proBNP, Troponin I, CRP and procalcitonin) measurements change. [ Time Frame: Change between Day 1 and Day 14 follow up after enrollment. ]

  Day 1 and Day 14.

Study Arms (3)

Treatment group 1

PLACEBO COMPARATOR

Control placebo (Vitamin C - 500mg / day, for 10 days)

Drug: Vitamin C

Treatment group 2

ACTIVE COMPARATOR

N-acetylcysteine (NAC; 1800 mg / day, for 10 days)

Drug: N-acetylcysteine (NAC)

Treatment group 3

ACTIVE COMPARATOR

NAC (1800 mg / day) + bromhexine-BMX (32 mg / day for 10 days)

Drug: NAC + Bromhexine (BMX)

Interventions

Vitamin C DRUG

Vitamin C 500 mg / day for ten days

Treatment group 1

N-acetylcysteine (NAC) DRUG

N-acetylcysteine 1800 mg / day for ten days.

Treatment group 2

NAC + Bromhexine (BMX) DRUG

NAC + Bromhexine (BMX) 32 mg / day for ten days.

Treatment group 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with clinical signs and symptoms of COVID-19; and
• patients over 18 years and below 60 years of age.

You may not qualify if:

• participate in another clinical intervention study;
• you have a disease or other medical condition that prevents you from using the medications for this intervention;
• patient incapable of ingesting, retaining and absorbing the intervention medications; and (d) is mentally disabled.

Sponsors & Collaborators

• Universidade Federal do Ceara: lead
• Paulista School of Medicine-EPM, UNIFESP: collaborator
• Health Surveillance Secretariat - SVS: collaborator
• Central Laboratory of Public Health of Ceara - LACEN-CE: collaborator
• Leonardo da Vinci Hospital - HLV: collaborator
• São José Hospital for Infectious Diseases - HSJ: collaborator
• Ceará Health Secretariat - SESA: collaborator
• Municipal Health Secretary - SMS-Fortaleza: collaborator

Study Sites (1)

Núcleo de Biomedicina - NUBIMED

Fortaleza, Ceará, 60430270, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ascorbic Acid; Acetylcysteine; Bromhexine

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

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Aniline Compounds; Amines; Cyclohexylamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinical trial will be masked by participant, care provider, investigator and outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: (1) Placebo control; (2) N-acetylcysteine treatment (NAC); and (3) NAC + Bromhexine treatment.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 16, 2021
• Study Start: July 15, 2021
• Primary Completion: April 9, 2022
• Study Completion: June 9, 2022
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

BR (1)