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

Universidade Federal do Ceara

Status and phase: Unknown; Phase 3

Conditions: COVID-19

Treatments: Drug: NAC + Bromhexine (BMX); Drug: Vitamin C; Drug: N-acetylcysteine (NAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04928495

AVANTI-C19

Details and patient eligibility

About

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

Full description

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.

Enrollment: 219 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The inclusion criteria will be:

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

The exclusion criteria will be:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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219 participants in 3 patient groups, including a placebo group

Treatment group 1

Placebo Comparator group

Description:

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

Treatment:

Drug: Vitamin C

Treatment group 2

Active Comparator group

Description:

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

Treatment:

Drug: N-acetylcysteine (NAC)

Treatment group 3

Active Comparator group

Description:

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

Treatment:

Drug: NAC + Bromhexine (BMX)