A Phase 3 interventional study of Vitamin C and N-acetylcysteine (NAC) in COVID-19, sponsored by Universidade Federal do Ceara. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-06-30.
Sponsored by Universidade Federal do Ceara · Phase 3, Interventional, and Treatment
Among 12 studies testing acetylcysteine in COVID-19 — 1 open to participants now, 2 under way, none of them phase 3. Acetylcysteine · COVID-19.
Among the 12 studies testing acetylcysteine in COVID-19, this one is the 2nd largest by planned enrollment, is one of 4 that started in 2021, is one of 3 in phase 3, and was the 7th registered.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 219 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →1 of the 12 studies testing acetylcysteine in COVID-19 is open now, in 1 country. Each count lists the studies.
Acetylcysteine: first FDA approval 1963 (MUCOMYST). What it is approved for, and how studies give it, is on its page →
Of the 356 COVID-19 studies recruiting now, 207 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 136 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2020; this study’s year is marked. 4 started in 2021.
Median enrollment 70 across the 12 interventional studies. Of the 5 that completed or were terminated, 1 (20%) have results posted.
1 of 12 have an industry lead sponsor. The 10 most frequent:
Universidade Federal do Ceara is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Universidade Federal do Ceara has 2 studies filed under COVID-19 — fewer than ten, so there is no comparison to draw.
1 of the studies testing acetylcysteine in COVID-19 that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04374461Memorial Sloan Kettering Cancer CenterA Study of N-acetylcysteine in Patients With COVID-19 Infection | 2027-05 |
Among the 12 studies testing acetylcysteine in COVID-19, from their registry updates:
Nothing recorded among them since 2026-09-25.
Clinical, control, double-blind, randomized experimentation with N-acetylcysteine and bromhexine for COVID-19.
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.
The inclusion criteria will be:
The exclusion criteria will be:
Control placebo (Vitamin C - 500mg / day, for 10 days)
Drug: Vitamin C
N-acetylcysteine (NAC; 1800 mg / day, for 10 days)
Drug: N-acetylcysteine (NAC)
NAC (1800 mg / day) + bromhexine-BMX (32 mg / day for 10 days)
Drug: NAC + Bromhexine (BMX)
Vitamin C 500 mg / day for ten days
N-acetylcysteine 1800 mg / day for ten days.
Drug pages: Acetylcysteine · Bromhexine
NAC + Bromhexine (BMX) 32 mg / day for ten days.
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.
Time frame: Day 7
SARS-CoV-2 RNA viral load measurements change. [ Time Frame: Change between Day 1 and Day 7 follow up after enrollment. ]
Molecular diagnostic analyzes will be done by Real-Time PCR (qPCR) based on official guidelines determined by the American CDC (CDC-006-00019, Revision: 03; https://www.fda.gov/media/134922/download). The nasopharyngeal swab samples collected (Covid-19 test) will proceed to the nucleic acid isolation (NuAc). All qPCR reactions will be by uniplex diagnosis. Results will be reported in copies of RNA / ml.
Time frame: 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; %). ]
The IgM / IgG immune response to SARS-CoV-2 will be qualitative measure using rapid diagnostic test provide by Eco Diagnóstica (Nova Lima, MG, Brazil).
Time frame: 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. ]
We will use the Luminex XMAP Technology (MAGPIX® System, Merck Co., Kenilworth, NJ) which includes the simultaneous analysis, in the same plasma sample (volume of 25 uL), of a panel of protein markers of pro and anti-inflammatory activity (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). Specific antibodies covalently linked to the carboxylated microspheres containing different specific fluorochromes will be used. Standard curves will be constructed for each protein and then their quantification. Results will be reported in pg / mL.
Time frame: Day 1 and Day 14.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2021; primary completion for Apr 2022, 8 months later.
Of 285 non-industry phase 3 interventional studies under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's planned 8 months is below that.
Counting every sponsor, half of 453 studies reached it within 9 months; a quarter within 4 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acetylcysteine · Bromhexine
Universidade Federal do Ceara