Design: Retrospective case series study. Background: In France, the combination hydroxychloroquine (HCQ) and azithromycin (AZ) is used in the treatment of COVID-19. Effects of Early Use of Nitazoxanide in Patients With COVID-19. Please remove one or more studies before adding more. Effects of Early Use of Nitazoxanide in Patients With COVID-19. medRxiv. Overview. 2020 May 6. pii: 2020.05.01.20087130. doi: 10.1101/2020.05.01.20087130. Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by percentage. Use Authorization In patients with COVID-19 on supplemental oxygen, we recommend dexamethasone with Remdesivir as first-line therapy. Available as soon as the editorial board of the journal accepting the manuscript requires. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: SARS-COV-2 viral load - absolute number [ Time Frame: Day1 ], SARS-COV-2 viral load - absolute number [ Time Frame: Day8 ], SARS-COV-2 viral load - percentage [ Time Frame: Day 1 ], SARS-COV-2 viral load - percentage [ Time Frame: Day 8 ], Hospital admission rate - absolute number [ Time Frame: Day8 ], Hospital admission rate - percentage [ Time Frame: Day8 ], Serum Interleukin-6 [ Time Frame: Day 3 ], Serum Interleukin-6 [ Time Frame: Day 8 ], Serum Interleukin-1-beta [ Time Frame: Day 3 ], Serum Interleukin-1-beta [ Time Frame: Day 8 ], Serum Interleukin-8 [ Time Frame: Day 3 ], Serum Interleukin-8 [ Time Frame: Day 8 ], Serum tumor necrosis factor (TNF)-alfa [ Time Frame: Day 3 ], Serum tumor necrosis factor (TNF)-alfa [ Time Frame: Day 8 ], Serum interferon-gamma [ Time Frame: Day 3 ], Serum interferon-gamma [ Time Frame: Day 8 ], Serum monocyte chemoattractant protein (MCP)-1 [ Time Frame: Day 3 ], Serum monocyte chemoattractant protein (MCP)-1 [ Time Frame: Day 8 ], Complete blood count [ Time Frame: Day 3 ], Complete blood count [ Time Frame: Day 8 ], C-reactive protein - absolute number [ Time Frame: Day 3 ], C-reactive protein - absolute number [ Time Frame: Day 8 ], C-reactive protein - percentage [ Time Frame: Day 3 ], C-reactive protein - percentage [ Time Frame: Day 8 ], Adverse events - percentage [ Time Frame: Day 8 ], Adverse events - absolute number [ Time Frame: Day8 ], Treatment discontinuation rate - absolute number [ Time Frame: Day8 ], Treatment discontinuation rate - percentage [ Time Frame: Day8 ], Clinical scenario compatible with infection by the SARS-CoV-2 [Characteristic symptoms of COVID-19 (fever and / or cough and / or fatigue), Beginning 1 to 3 days before inclusion in the study, Providing written and informed consent or the same consent signed by a family member, Negative result of RT-PCR for SARS-COV2 collected on admission, History of severe liver disease (Child Pugh C class), Individuals with known hypersensitivity to study drug, Previous treatment with the study medication during the last 30 days, Clinical suspicion of tuberculosis and bacterial pneumonia. Without covid-19 testing, they said, potentially virus-free patients in their 80s and 90s were at risk of being dosed with an unproven drug they didn’t need or, worse yet, could hurt them. NTZx NTZx and its circulating active metabolite, tizoxanide, inhibit the replication of a wide range of viruses, both RNA and DNA. Patients were randomly allocated into one of the two groups: A or B. Choosing to participate in a study is an important personal decision. We do not endorse the use of Baricitinib as first-line as it showed no mortality benefit based on preliminary results from the ACTT-2 trial. Talk with your doctor and family members or friends about deciding to join a study. Compare the hospital admission rate of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, in the period of 8 days; verified by information actively collected from patients or family members; quantified by absolute number. Two main processes are thought to drive the pathogenesis of COVID-19.  (Clinical Trial). Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom. The novel coronavirus has undoubtedly impacted the environment. About Study Results Reporting on ClinicalTrials.gov. To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by laboratory tests and expressed by the absolute number between the two groups. The effect was maintained after resupination in half of the patients. One of the earliest side effects of patients who tested positive for COVID-19 was a distinct loss of their sense of taste and smell. Nitazoxanide use in comorbidities. Background While there was a lack of pharmacological interventions proven to be effective in early, outpatient settings for COVID-19, in a prospective, open-label observational study (pre-AndroCoV Trial) the use of nitazoxanide, ivermectin and hydroxychloroquine demonstrated similar effects, and apparent improvement of outcomes compared to untreated patients. Due to their well-established anti-infectious and anti-inflammatory properties, quinine derivatives have been sought as potential … Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo (P < 0.001). Compare the levels of inflammatory mediators: IL-1-beta from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups. • Given the possibility of a limited supply of the casirivimab plus imdevimab combination, as well as challenges distributing and administering the drugs, patients at highest risk for COVID-19 progression should be prioritized for use of the drugs through the EUA. J Infect Public Health. Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Compare the levels of inflammatory mediators: tumor necrosis factor (TNF)-alfa from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups. Take home message This was the first study to evaluate the effect of early nitazoxanide therapy in mild Covid-19. Update in: Br J Clin Pharmacol. Wei XB, Wang ZH, Liao XL, et al. Editorial board of the Journal accepting the manuscript. It has action against 16 strains of Influenza A virus subtypes H1N1, H3N2, H3N2v, … Epub 2014 Aug 7. Review. It will be used for its anti‐inflammatory and anti‐cytokine storm effects when treating COVID‐19. Patients received nitazoxanide 500mg 8/8hours, for 5 days. In another multi-centric retrospective study of 181 patients with COVID pneumonia from France, there was no difference in worse clinical outcomes between the two arms (Table 1 ) [ 5 ]. Individual Participant Data (IPD) Sharing Statement: The investigators plan on sharing all IPD that underlie results in a publication for editorial board, with cautious of not sharing confidential data. Compare the evolution of viral load in naso- and oropharyngeal swab in patients with COVID-19 treated with nitazoxanide or placebo on day 1; verified using the RT-PCR technique; quantified by the percentage change between the two groups. 2014 Oct;110:94-103. doi: 10.1016/j.antiviral.2014.07.014. Results In the entire cohort, there were 111 911 non-users, 14 163 current PPI users and 6242 past PPI users. Antiviral Res. Moreover, when nitazoxanide was given as 600 mg twice daily for 5 days, it’s proved to reduce of the duration of symptoms in patients with acute uncomplicated influenza with minor adverse effects and this dose regimen might be reasonably considered to be used combined with azithromycin in a suggested new COVID-19 protocol aiming to test their integrated potential to decrease SARS CoV-2 … Children ages 1 to 11 years should use only the oral suspension (liquid) form of nitazoxanide. Rajoli RK, Pertinez H, Arshad U, Box H, Tatham L, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, Aljayyoussi G, Pennington SH, Hill A, Boffito M, Ward SA, Khoo SH, Bray PG, O'Neill PM, Hong WD, Biagini G, Owen A. However, existing evidence regarding the use of steroids in this specific patient population remains inconclusive due to methodological limitations. Prone positioning was feasible and effective in rapidly ameliorating blood oxygenation in awake patients with COVID-19-related pneumonia requiring oxygen supplementation. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Nitazoxanide is not expected to be harmful to an unborn baby. However, early nitazoxanide therapy was safe and reduced viral load significantly. Overall Status: Completed | Estimated Enrollment: 392. Therapeutic Management of Patients with COVID-19. Colchicine was considered for this purpose based on well-recognised anti-inflammatory effects and potential antiviral properties. Frontline health workers and elderly patients will get the first … Calculation of the sample size was based on a previous study which demonstrated that 78% of Covid-19 patients in group 4 (Hospitalized without oxygen therapy), according to the WHO ordinal classification, experienced complete resolution of symptoms after receiving placebo.10 In the present trial, patients were classified as group 2 (Symptomatic and independent), and a greater degree of recovery as measured by symptom-free days (80%) was expected even after placebo. The Panel recommends against the use of high-dose chloroquine (600 mg twice daily for 10 days) for the treatment of COVID-19 (AI) . Compare the levels of inflammatory mediators: tumor necrosis factor (TNF)-alfa from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups. Theoretically, NSAIDs when used as early as possible during the clinical course of COVID-19 might prevent disease progression or even reverse lymphocytopenia and we suggest it might be added to his newly suggested nitazoxanide/azithromycin protocol for early management of COVID-19 but in a separate arm for nitazoxanide/azithromycin/ibuprofen as well as to add NSAIDs to any other already adopted protocol for early cases of COVID-19 … The aim of this report is to describe the results of treating COVID-19 positive patients with nitazoxanide in three clinical settings: pregnancy/puerperium, hospitalized patients in an Internal Medicine Service and in an ambulatory setting. Epub 2016 Apr 16. Review. Patients received labelled medication: A or B, by the pharmacist. In the current study, 6 patients with COVID-19 and respiratory failure received convalescent plasma a median of 21.5 days after viral shedding was first detected, all tested negative for SARS-CoV-2 RNA within 3 days after infusion, and 5 eventually died. Rossignol JF. Nitazoxanide did not accelerate symptom resolution after 5 days of therapy but did reduce viral load significantly with no serious adverse events. Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxis. Read our, ClinicalTrials.gov Identifier: NCT04552483, Interventional Compare the levels of inflammatory mediators: IL-8 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups. medRxiv. At least one in five expected U.S. ED visits for MI or stroke and one in 10 ED visits for hyperglycemic crisis did not occur during the initial months of the COVID-19 pandemic. 23,24 NIPPV may generate aerosol spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and thus increase nosocomial transmission of the infection. Keywords provided by Jose Roberto Lapa e Silva, Universidade Federal do Rio de Janeiro: Why Should I Register and Submit Results? Antiviral Res. Results 1439 cases from 47 countries were included (mean age 44.1 years, 51.4% men) of whom 112 patients (7.8%) had severe … Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. First Received: September 9, 2020 | Last Updated: November 3, 2020 . 2020 Oct 21;:. Compare the levels of inflammatory mediators: monocyte chemoattractant protein (MCP)-1 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups. Immune System Implications of Cardiovascular Diseases and COVID-19. SARITA-2 is a multicenter, randomized, placebo-controlled, parallel, -blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide in the early phase of the COVID-19 (Coronavirus Disease-19). Patients diagnosed with COVID-19 will be randomly divided into 2 groups: experimental and control groups. COVID-19 is an emerging, rapidly evolving situation. Effects of Nitazoxanide Administration to Patients in the Initial Phase of COVID-19, 18 Years and older   (Adult, Older Adult), Jose Roberto Lapa e Silva, Clinical Investigator, Universidade Federal do Rio de Janeiro. Nitazoxanide did not accelerate symptom resolution after 5 … Side effects of Nitazoxanide. Assess the incidence and profile of adverse events reported throughout the study, by treatment group; verified by information actively collected from patients or family members; quantified by percentage. Effects of Early Use of Nitazoxanide in Patients With COVID-19. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. In COVID-19 patients with ARDS, treatment with steroids is associated with a decreased risk of death compared with patients who do not receive steroids (46% vs. 61.8%) . However, early nitazoxanide therapy was safe and reduced viral load significantly. To be clear, the benefit of using dexamethasone is seen in the sickest hospitalized patients, says Bram Rochwerg, a critical care physician at McMaster University in Canada who was not involved in the RECOVERY trial.The drug should not be taken prophylactically or by stable outpatients with COVID-19… Compare the levels of inflammatory mediators: (interleukin [IL] -6 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups. Population: 392 Patients with COVID-19, confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease. Study record managers: refer to the Data Element Definitions if submitting registration or results information. COVID-19: Moderna vaccine nears approval in US as rollout of Pfizer jab continues. The study reports a survival rate of over 99% in patients with confirmed positive cases of COVID-19. Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease. 2020 Oct 21;:. Experimental group: 196 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). In the present study, colchicine was proposed to patients with COVID-19, and its effects compared with ‘standard-of-care’ (SoC). Genetic and Rare Diseases Information Center. To evaluate the levels of C-reactive protein (CRP) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by laboratory tests and expressed by the absolute number between the two groups. Further studies are warranted to ascertain the potential benefit of this technique in improving final respiratory and global outcomes. New research suggests the damage comes from the immune system's reaction to … Tell your doctor if you are pregnant. Although there are no published studies of inhaled nitric oxide in patients with COVID-19, a Cochrane review of 13 trials of inhaled nitric oxide use in patients with ARDS found no mortality benefit. 2020 May 6. pii: 2020.05.01.20087130. doi: 10.1101/2020.05.01.20087130. Review of safety and minimum pricing of nitazoxanide for potential treatment of COVID-19. The tablet form of nitazoxanide should not be given to a child younger than 12 years old. After propensity score matching, the SARS-CoV-2 test positivity rate was not associated with the current or past use of PPIs. Patients were categorized into non-severe (n= 151), severe (n = 146) and critical (n=26) based on the clinical presentation at … Last Updated: December 3, 2020. Why Should I Register and Submit Results? Universidade Federal do Rio de Janeiro 3 November 2020. Hu et al (2020) 17 conducted a retrospective review of 323 patients hospitalised with COVID-19 at Tianyou Hospital between 8 th January and 20 th February 2020. It's too early to say if this is higher with COVID-19 patients, although some regions like New York report as many as 80% of people infected with the virus die after being placed on ventilation. One patient underwent genetic testing and was not found to carry any Parkinson's risk variants. Early reports from China and France suggested that patients with severe symptoms of COVID-19 improved more quickly when given chloroquine or hydroxychloroquine. Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by absolute number. Interestingly, inhibition of PDI by nitazoxanide … Some doctors were using a combination of hydroxychloroquine and azithromycin with some positive effects. In patients with mild Covid-19, symptom resolution did not differ between the nitazoxanide and placebo groups after 5 days of therapy. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552483. Control group: 196 patients received placebo 8/8 hours for 5 days. The unparalleled public distress caused by this pandemic mandated an urgent quest for an effective approach to manage or treat this disease. Study record managers: refer to the Data Element Definitions if submitting registration or results information. This was the first study to evaluate the effect of early nitazoxanide therapy in mild Covid-19. The pandemic of COVID-19, caused by SARS-CoV-2, has recently overwhelmed medical centers and paralyzed economies. Information provided by (Responsible Party): Jose Roberto Lapa e Silva, Universidade Federal do Rio de Janeiro. Rossignol JF. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. It has been proposed that the potent anti-inflammatory effects of corticosteroids might prevent or mitigate these deleterious effects. Timing is everything. Take home message This was the first study to evaluate the effect of early nitazoxanide therapy in mild Covid-19. Compare the levels of inflammatory mediators: interferon-gamma from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups. Phase: Phase 2 | Start Date: June 8, 2020. Because it's difficult to predict long-term outcomes from the new COVID-19 virus, scientists are looking at the long-term effects seen in related viruses, such as the virus that causes severe acute respiratory syndrome (SARS).. Please remove one or more studies before adding more. 1 No data support use of baloxavir in the treatment of COVID-19 NIH COVID-19 Treatment Guidelines Rajoli RK, Pertinez H, Arshad U, Box H, Tatham L, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, Aljayyoussi G, Pennington SH, Hill A, Boffito M, Ward SA, Khoo SH, Bray PG, O'Neill PM, Hong WD, Biagini G, Owen A. The most common adverse effects are GIT as nausea and occasional stomach cramps with mild diarrhea, reduced appetite and vomiting. Setting: General practice. Evaluate evolution of complete blood count with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 8; verified by laboratory tests and expressed by the absolute number between the two groups. J Virus Erad. In a survey among patients with symptomatic COVID-19 not severe enough to require hospitalization, 35 percent of patients had not returned to their usual state of health two to three weeks after diagnosis. After propensity score matching, the SARS-CoV-2 test positivity rate was not associated with the current or past use of PPIs. Compare the evolution of viral load in naso- and oropharyngeal swab in patients with COVID-19 treated with nitazoxanide or placebo on day 1; verified using the RT-PCR technique; quantified by the absolute number. Abstract Background The efficacy of interleukin-6 receptor blockade in hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving mechanical ventilation is unclear. Nitazoxanide: a first-in-class broad-spectrum antiviral agent. Myasthenia gravis (MG) is an autoimmune disease characterised by fluctuating muscle weakness with potentially life-threatening symptoms due to insufficiency of respiratory muscles. October 2020 DOI: 10.13140/RG.2.2.31352.67847 Calculation of the sample size was done by G*Power 3.1.9.2 (Universität Düsseldorf, Düsseldorf, Germany). Ministry of Science and Technology, Brazil, Complexo Hospitalar Municipal de São Caetano do Sul, Hospital de Transplante Doutor Euryclides de Jesus Zerbini, Secretaria Municipal de Saúde de Guarulhos, Hospital e Maternidade Therezinha de Jesus, Secretaria de Estado de Saúde do Distrito Federal. Pepperrell T, Pilkington V, Owen A, Wang J, Hill AM. Patients treated with these drugs should be aware of possible side effects, including eye … Control group: 196 patients, placebo 8/8 hours for 5 days. Early COVID-19 Therapy with Azithromycin Plus Nitazoxanide, Ivermectin or Hydroxychloroquine in Outpatient Settings Significantly Reduced Symptoms Compared to Known Outcomes in Untreated Patients : Comparison of HCQ, nitazoxanide, and ivermectin showing similar effectiveness for overall clinical outcomes in COVID-19 when used before seven days of symptoms, and overwhelmingly … Treatment usually includes immunosuppressive drugs and cholinesterase inhibitors. During the first months of the coronavirus (COVID-19) pandemic, some physicians used the malaria drugs Plaquenil (hydroxychloroquine) and Aralen (chloroquine) as potential treatments for the coronavirus.These drugs are no longer recommended for emergency use in hospitalized patients with COVID-19. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death (P = 0.29). Ministry of Science and Technology, Brazil, Complexo Hospitalar Municipal de São Caetano do Sul, Hospital de Transplante Doutor Euryclides de Jesus Zerbini, Secretaria Municipal de Saúde de Guarulhos, Hospital e Maternidade Therezinha de Jesus, Secretaria de Estado de Saúde do Distrito Federal. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Objective: To describe outcomes of patients with coronavirus disease 2019 (COVID-19) in the outpatient setting after early treatment with zinc, low dose hydroxychloroquine, and azithromycin (the triple therapy) dependent on risk stratification. See ClinicalTrials.gov for a list of clinical trials that are evaluating the use of vitamin C in patients with COVID-19. Review of safety and minimum pricing of nitazoxanide for potential treatment of COVID-19. J Virus Erad. Compare the levels of inflammatory mediators: (interleukin [IL] -6 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups. "These cases of acute Parkinson's in patents with COVID-19 … Placebo 8/8 hours for 5 days in the early clinical phase of COVID-19. Simple blind design. Methods: We retrospectively report on 1061 SARS-CoV-2 positive tested patients treated for at least three days with the following regimen: HCQ (200 mg three times daily for ten days) + AZ (500 mg on day 1 followed by 250 mg daily for the next four days). Update in: Br J Clin Pharmacol. treatment of COVID-19. Reduction in the duration of asthenia of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom. NIPPV has a high failure rate in both patients with non-COVID-19 viral pneumonia 21,22 and patients with ARDS. Compare the levels of inflammatory mediators: IL-8 from patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups. Patients might have delayed or avoided seeking care because of fear of COVID-19, unintended consequences of recommendations to stay at home, or other reasons. J Infect Public Health. Nitazoxanide: a first-in-class broad-spectrum antiviral agent. From wildlife conservation to the renewable energy sector, COVID-19's effects can't be ignored. Pepperrell T, Pilkington V, Owen A, Wang J, Hill AM. References. Nitazoxanide 500mg 8/8 hours for 5 days in the early clinical phase of COVID-19. antibody clinical trials with patients who have mild to moderate COVID-19. Read our disclaimer for details. A CDU from thigh to ankle at selected sites with Doppler waveforms and images was performed early during ICU stay in patients admitted with COVID-19. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Patients received placebo 500mg 8/8hours, for 5 days. Information provided by (Responsible Party): Jose Roberto Lapa e Silva, Universidade Federal do Rio de Janeiro, No Study Results Posted on ClinicalTrials.gov for this Study. COVID-19 is an emerging, rapidly evolving situation. 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