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

NCT ID: NCT04928495

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2022-06-09

Brief Summary

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

Detailed Description

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Several therapeutic agents have been evaluated for the treatment of COVID-19, but only one, the antiviral drug called remdesivir administered intravenously, has shown to be effective in shortening the duration of the disease by 26.7% in critically ill patients. This proposal has the primary objective (1) to determine the effect of N-acetylcysteine (NAC; reducing substance and complementary viral intercepting action) and combination of NAC + bromhexine (BMX; viral protease inhibitor), on the clinical duration of COVID-19 evaluated on the 7th. day of outpatient follow-up, observing the score of clinical signs and symptoms of the disease. The study has as secondary objectives: (2) to assess the change in viral load by RT-qPCR of SARS-CoV-2 between the 1st, 7th, and 14th. days of the experimental protocol; (3) determine the action of NAC and BMX + NAC on the immune response using the rapid ELISA test (IgM / IgG) to be performed on the 14th. monitoring day of the experimental protocol; and (4) Assess the effect of NAC and BMX + NAC on the change in the serum level of inflammation biomarkers and reducing substances (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, PCR and procalcitonin; glutathione peroxidase-GPx; superoxide dismutase-SOD and catalase-CAT) of patients collected on the 1st. and 14 o. study days. The study will be a prospective, double-blind, placebo control and randomized clinical trial of a total of 219 patients, 73 for each treatment group, with mild to moderate disease, equal to or above 18 years of age, with clinical signs and symptoms. of COVID-19 and certified by the RT-qPCR test for the detection of SARS-CoV-2 viral load. The study will be carried out using the Surveillance, Service and Research Network - REVAP-C19, NUBIMED, FAMED, UFC, Fortaleza, CE in order to facilitate the efficiency of patients' entry into the study. The random groups of treatments will be: (1) Placebo control (Vitamin C - 500 mg / day, for 10 days); (2) N-acetylcysteine (NAC; 1800 mg / day, for 10 days); and (3) NAC (1800 mg / day, for 10 days) + Bromhexine Hydrochloride (BMX; 32 mg / day, for 10 days). The study has the perspective of evaluating the effectiveness of NAC alone or combined with BMX in the duration of the clinical score of mild to moderate cases of COVID-19. The study will also assess secondary parameters such as the effect of drugs on changing viral load, immune response, and changing the inflammatory reaction and reducing substances in the plasma of the study patients. In this sense, the trial plans to minimize the evolution of the disease to severe cases, thus alleviating the collapse of the health system and minimizing the social, economic and health disorders of the pandemic by SARS-CoV-2.

Conditions

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COVID-19

Keywords

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N-acetylcysteine Bromhexine COVID-19 Clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

(1) Placebo control; (2) N-acetylcysteine treatment (NAC); and (3) NAC + Bromhexine treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The clinical trial will be masked by participant, care provider, investigator and outcomes assessor.

Study Groups

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Treatment group 1

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

Group Type PLACEBO_COMPARATOR

Vitamin C

Intervention Type DRUG

Vitamin C 500 mg / day for ten days

Treatment group 2

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

Group Type ACTIVE_COMPARATOR

N-acetylcysteine (NAC)

Intervention Type DRUG

N-acetylcysteine 1800 mg / day for ten days.

Treatment group 3

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

Group Type ACTIVE_COMPARATOR

NAC + Bromhexine (BMX)

Intervention Type DRUG

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

Interventions

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Vitamin C

Vitamin C 500 mg / day for ten days

Intervention Type DRUG

N-acetylcysteine (NAC)

N-acetylcysteine 1800 mg / day for ten days.

Intervention Type DRUG

NAC + Bromhexine (BMX)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paulista School of Medicine-EPM, UNIFESP

UNKNOWN

Sponsor Role collaborator

Health Surveillance Secretariat - SVS

UNKNOWN

Sponsor Role collaborator

Central Laboratory of Public Health of Ceara - LACEN-CE

UNKNOWN

Sponsor Role collaborator

Leonardo da Vinci Hospital - HLV

UNKNOWN

Sponsor Role collaborator

São José Hospital for Infectious Diseases - HSJ

UNKNOWN

Sponsor Role collaborator

Ceará Health Secretariat - SESA

UNKNOWN

Sponsor Role collaborator

Municipal Health Secretary - SMS-Fortaleza

UNKNOWN

Sponsor Role collaborator

Universidade Federal do Ceara

OTHER

Sponsor Role lead

Responsible Party

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Aldo Ângelo Moreira Lima

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Núcleo de Biomedicina - NUBIMED

Fortaleza, Ceará, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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AVANTI-C19

Identifier Type: -

Identifier Source: org_study_id