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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4256 | Vitamin Super B-Complex Wiki | 0.45 |
| drug4537 | intradermal injection of BCG Vaccine Wiki | 0.26 |
| drug4012 | Thromboprophylaxis Wiki | 0.26 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2948 | Placebo Ribavirin Wiki | 0.26 |
| drug3791 | Study A Wiki | 0.26 |
| drug3669 | Sofosbuvir/Daclatasvir Wiki | 0.26 |
| drug4615 | non-RAS blocking antihypertensives Wiki | 0.26 |
| drug414 | Awake Proning Wiki | 0.26 |
| drug4653 | placebo for clazakizumab Wiki | 0.26 |
| drug551 | Best standard of care Wiki | 0.26 |
| drug2942 | Placebo Hydroxychloroquine Wiki | 0.26 |
| drug3357 | Retrospective data collection Wiki | 0.26 |
| drug4121 | UB-612 Wiki | 0.26 |
| drug3667 | Sofosbuvir and Ledipasvir Wiki | 0.26 |
| drug3872 | TCC-COVID mHealth solution Wiki | 0.26 |
| drug3794 | Study C Wiki | 0.26 |
| drug3873 | TCM prescriptions Wiki | 0.26 |
| drug2850 | Pegylated Interferon-α2b Wiki | 0.26 |
| drug838 | Candesartan Wiki | 0.26 |
| drug3795 | Study D Wiki | 0.26 |
| drug3793 | Study B Wiki | 0.26 |
| drug2945 | Placebo Nitazoxanide Wiki | 0.26 |
| drug2117 | Lenzilumab Wiki | 0.15 |
| drug910 | Chloroquine or Hydroxychloroquine Wiki | 0.15 |
| drug2170 | Lopinavir/Ritonavir Wiki | 0.13 |
| drug3361 | Ribavirin Wiki | 0.13 |
| drug3384 | Rivaroxaban Wiki | 0.12 |
| drug2220 | Lung ultrasound Wiki | 0.12 |
| drug927 | Clazakizumab Wiki | 0.11 |
| drug2916 | Placebo Wiki | 0.10 |
| drug904 | Chloroquine Wiki | 0.10 |
| drug3728 | Standard of Care Wiki | 0.08 |
| drug4650 | placebo Wiki | 0.07 |
| drug3829 | Survey Wiki | 0.07 |
| drug2029 | Ivermectin Wiki | 0.06 |
| drug421 | Azithromycin Wiki | 0.04 |
| drug1775 | Hydroxychloroquine Wiki | 0.03 |
Navigate: Correlations HPO
There are 15 clinical trials
Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.
Description: The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period.
Measure: Symptomatic laboratory-confirmed COVID-19 Time: up to 6 weeksDescription: The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period.
Measure: Symptomatic laboratory-confirmed VRI Time: up to 6 weeksTrial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
Azithromycin has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.
Description: the number of patients with virological cure
Measure: Number of patients with virological cure Time: 6 monthsThis is a pivotal phase III study to evaluate the efficacy of nitazoxanide in two different regimens (600 mg BID and 500 mg TID) to treat hospitalized patients with non-critical COVID-19.
Description: Evaluation of change in acute respiratory syndrome using WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
Measure: Need of mechanical ventilation Time: 14 daysDescription: Evaluation of change in oximetry, respiratory rate and need for oxygen therapy
Measure: Change in the pulmonary condition Time: Baseline, Day 7 and Day 14Description: Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction
Measure: Change in Clinical Condition Time: Baseline, Day 7 and Day 14Description: Evaluation of change in chest CT
Measure: Change in tomographic pulmonary condition Time: Baseline, Day 7Description: Evaluation of change in acute respiratory syndrome
Measure: Rate of mortality within 14-days Time: 14 daysDescription: Evaluation of change in inflammatory markers d-dimer and IL-6
Measure: Change in inflammatory markers Time: Baseine, Day 7, Day 14This is a pivotal phase III study to evaluate the efficacy of nitazoxanide in two different regimens (600 mg BID and 500 mg TID) to treat hospitalized patients with non-critical COVID-19.
Description: Evaluation of change in acute respiratory syndrome using WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
Measure: Need of mechanical ventilation Time: 14 daysDescription: Evaluation of change in oximetry, respiratory rate and need for oxygen therapy
Measure: Change in the pulmonary condition Time: Baseline, Day 7 and Day 14Description: Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction
Measure: Change in Clinical Condition Time: Baseline, Day 7 and Day 14Description: Evaluation of change in chest CT
Measure: Change in tomographic pulmonary condition Time: Baseline, Day 7Description: Evaluation of change in acute respiratory syndrome
Measure: Rate of mortality within 14-days Time: 14 daysDescription: Evaluation of change in inflammatory markers d-dimer and IL-6
Measure: Change in inflammatory markers Time: Baseine, Day 7, Day 14The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.
Description: PCR will be done to evaluate infection
Measure: The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study Time: 28 daysDescription: Number of participants with treatment-related adverse events
Measure: Incidence of Treatment-Emergent Adverse Events Time: 28 daysDescription: Symptomatic PCR positive subjects
Measure: The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study Time: 28 daysDescription: Asymptomatic PCR will be done to evaluate infection
Measure: The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study Time: 28 daysDescription: Subject adherence to treatment will be assessed through study diary record
Measure: Treatment adherence Time: 7 daysDescription: Proportion of patients with severe condition
Measure: Disease complication Time: 28 daysDescription: Proportion of patient that needed undergo an unscheduled visit
Measure: Incidence of subjects that underwent unscheduled visit Time: 28 daysThe aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.
Description: Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).
Measure: Change in signs and symptoms scale Time: 21 daysDescription: Number of participants with treatment-related adverse events
Measure: Incidence of Treatment-Emergent Adverse Events Time: 21 daysDescription: Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
Measure: The proportion of subjects hospitalized after start of treatment and before the end of the study Time: 21 daysDescription: Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
Measure: The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study Time: 21 daysDescription: Time required (days) to full symptom recovery
Measure: Duration of symptoms Time: 21 daysDescription: Evaluation of change in acute respiratory syndrome
Measure: Rate of mortality within 21-days Time: 21 daysEvaluation of the efficacy and safety of NTX in adult patients (≥18 years and <60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.
Description: Erradication will be considered a reduction of the viral load on day 7 greater than 35% with respect to placebo. Extraction of genomic material will be performed using a QIAgen mini kit (QIAmp viral RNA) validated by the CDC (United States Center for Disease Control and Prevention (https://www.fda.gov/media/134922/download) (CDC-006-00019) Viral load will be quantified with the following detection kits: Commercial Kit: PCR-EUA-CDC-nCoV-IFU. Commercial KIT SENTINEL - STAT-NAT Covid 19B (Berlín). Rational: In mild cases of COVID-19, 50% of the patients eradicated the virus within a period of 3 weeks, 25% eradicated the virus before the 13th day, 75% during the first month and the rest were " late eradicators." This latter subgroup of patients has been associated with severe cases of COVID-19 disease.
Measure: Eradication of SARS COV-2 from patients' respiratory tract secretions by treatment day 7th. Time: 7 dayDescription: Consequently, in mild cases, viral eradication will likely occur more frequently during the first to second week of COVID-19 disease; less than 15% could eradicate the virus during the first week of symptom onset. From an epidemiological point of view, increasing the viral eradication rate from less than 15% to more than 35% during the first two weeks of treatment would be clinically relevant.(seven), 14 (fourteen) and 35 (thirty-five) after starting treatment compared to the baseline measurement.
Measure: Comparative decrease of the viral load Time: 3 - 35 daysDescription: Clinical improvement according to the WHO COVID-19 ordinal scale. Minimun 0 (zero), (best), maximum 8 (eight) (worst)
Measure: Clinical improvement Time: 1 - 35 daysDescription: Percentage of pneumonia patients meeting severity criteria.
Measure: Pneumonia patients meeting severity criteria. Time: 1 - 35 daysDescription: Number of days with fever (axillary temperature higher than 37.5°C).
Measure: Number of days with fever Time: 1 - 35 daysDescription: Percentage of patients requiring mechanical ventilation through orotracheal intubation (OT) and/or ICU hospitalization.
Measure: Patients requiring mechanical ventilation Time: 1 - 35 daysDescription: Mortality rate.
Measure: Mortality rate. Time: 1- 35 daysDescription: Lymphocyte recovery (absolute lymphocyte count > 1000 / mm3).
Measure: Lymphocyte recovery Time: 7 dayDescription: Days of ICU hospitalization.
Measure: ICU hospitalization. Time: 1 - 35 daysDescription: Oxygen saturation (SpO2) > 92% (at ambient FiO2).
Measure: Oxygen saturation Time: 1 - 35 daysDescription: Days of hospitalization
Measure: Days of hospitalization Time: 1 - 35 daysDescription: Respiratory rate per minute (in afebrile state conditions).
Measure: Respiratory rate Time: 1 - 35 daysTrial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
Description: To evaluate the effect of nitazoxanide in reducing the time to sustained response compared to placebo in subjects with mild or moderate COVID-19
Measure: Reducing the Time to Sustained Response Time: Up to 21 daysDescription: To evaluate the effect of nitazoxanide in reducing the rate of progression to severe COVID-19 illness compared to placebo
Measure: Reducing the Rate of Progression Time: Up to 21 daysThe efficacy of treating COVID-19 infection by using Sofosbuvir/Ledipasvir and Nitazoxanide will be examined. Included patients will be into 3 groups. The 1st group will receive Sofosbuvir/Ledipasvir plus the standard care treatment (SCT). The 2nd group will take Nitazoxanide and SCT, while the 3rd group will receive only SCT. Then the clinical improvement and the rate of PCR change from positive to negative will be evaluated in each group.
Description: The PCR will be done at time of recruitment, day 5, 8, 11, and 14. The time taken to have negative will be measured in each group.
Measure: Change of PCR from positive to negative Time: 2 weeksDescription: Clinical improvement will be measured by detection of downgrading of cases severity according to the World Health Organization case severity classification.
Measure: Clinical improvement Time: 2 weeksDescription: All patients will be asked about any possible adverse effects that they may suffer from taken drugs during their follow up. Any mentioned side effect will be reported. Drug discontinuation and it cause will be also reported if it happened.
Measure: Adverse events Time: 2 weeksCOVID-19 due to SARS-CoV-2 infection is a rapidly escalating global pandemic for which there is no proven effective treatment. COVID-19 is multi-dimensional disease caused by viral cytopathic effects and host-mediated immunopathology. Therapeutic approaches should logically be based on interventions that have direct anti-viral effects and favourably modulate the host immune response. Thus, an optimal drug regimen in ambulatory patients should collectively (i) target and reduce viral replication, (ii) upregulate host innate immune anti-viral responses, (iii) have favourable immunomodulatory properties, and (iv) minimise disease progression to hospitalisation thus circumventing the 'cytokine storm' that likely underpins ARDS and multi-organ failure. Nitazoxanide (NTZ) is an antiprotozoal drug that is FDA-approved for treating Cryptosporidium and Giardia and has an excellent safety record for a variety of indications, but primarily as an anti-parasitic agent. It has proven broad anti-viral activity as it amplifies cytoplasmic RNA sensing, potently augments type I interferon and autophagy-mediated anti-viral responses, has immunomodulatory properties e.g inhibits macrophage IL-6 production, and interferes with SARS-CoV-2 glycosylation. It has been shown to have anti-viral activity against several viruses including Ebola, influenza, hepatitis B and C, rotavirus and norovirus. With regard to respiratory viral infections, NTZ was evaluated in uncomplicated influenza and demonstrated a reduction in the median time to symptom recovery. By contrast, NTZ failed to show benefit in hospitalised patients with severe influenza suggesting that, as with oseltamivir (Tamiflu), it likely needs to be administered early in the course of the disease. NTZ has proven in vitro activity against SARS-CoV-2. NTZ inhibited the SARs-CoV-2 at a low-micromolar concentrations and in vivo evaluation in patients with COVID-19 has been strongly recommended. NTZ has an excellent drug-drug interaction profile. No clinically significant interactions are expected with commonly used antihypertensive agents, antidiabetics drugs, antiretroviral agents, steroids or commonly prescribed analgesics / anti-inflammatory agents. The investigators propose NTZ for the treatment of mild COVID-19 in non-hospitalised patients with HIV co-infection and/or enhanced risk for progression to severe disease (age > 50 years and/ or with comorbidity). The investigators will perform a randomised controlled trial enrolling 960 patients with mild disease. The primary outcome measure will be the proportion progressing to severe disease (hospitalisation) based on the WHO clinical progression scale (progression to stage 4 and beyond). Secondary outcome measures will include disease rates in contacts and effect on viral load, productive infectiousness using viral cultures, and ability to abrogate the generation of infectious aerosols using novel cough aerosol sampling technology. Recruitment is stratified and thus the study is powered to detect progression to severe disease in HIV-infected persons.
Description: Time-specific (30- and 60-day) disease severity based on the WHO clinical progression scale
Measure: Time specific disease severity Time: 60 daysDescription: Need for hospitalisation and length of hospital stay (in those admitted to hospital because of disease progression).
Measure: Progression to severe disease Time: 60 daysDescription: Length of time on high flow nasal oxygen or in the ventilator.
Measure: Need for respiratory support (high flow nasal oxygen, non-invasive ventilation, or intubation) in those admitted to hospital because of disease progression. Time: 60 daysDescription: Time-specific all cause of mortality
Measure: In-hospital and 30- and 60-day all-cause mortality. available). Time: 60 daysDescription: SARS-CoV-2 viral parameters [duration and burden of viral load and duration of viral culture positivity (viral shedding)
Measure: Time-specific viral load as measured by RT-PCR using NP swabs and sputum (where available). Time: 60 daysDescription: Assessment of SARS-CoV-2 presence in droplets and aerosols generated COVID-19 positive participants ( and infectiousness)
Measure: Cough aerosol sampling positivity Time: 60 daysMulticenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. 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. Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients, placebo 8/8 hours for 5 days.
Description: 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.
Measure: Days with fever Time: Day8Description: Reduction in the duration of cough 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.
Measure: Days with cough Time: Day8Description: 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.
Measure: Days with asthenia Time: Day8Description: 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
Measure: SARS-COV-2 viral load - absolute number Time: Day1Description: Compare the evolution of viral load in naso- and oropharyngeal swab in patients with COVID-19 treated with nitazoxanide or placebo on day 8; verified using the RT-PCR technique; quantified by the absolute number.
Measure: SARS-COV-2 viral load - absolute number Time: Day8Description: 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.
Measure: SARS-COV-2 viral load - percentage Time: Day 1Description: Compare the evolution of viral load in naso- and oropharyngeal swab in patients with COVID-19 treated with nitazoxanide or placebo on day 8; verified using the RT-PCR technique; quantified by the percentage change between the two groups.
Measure: SARS-COV-2 viral load - percentage Time: Day 8Description: 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.
Measure: Hospital admission rate - absolute number Time: Day8Description: 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 percentage.
Measure: Hospital admission rate - percentage Time: Day8Description: 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.
Measure: Serum Interleukin-6 Time: Day 3Description: 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.
Measure: Serum Interleukin-6 Time: Day 8Description: 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 3; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum Interleukin-1-beta Time: Day 3Description: 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.
Measure: Serum Interleukin-1-beta Time: Day 8Description: 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.
Measure: Serum Interleukin-8 Time: Day 3Description: 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.
Measure: Serum Interleukin-8 Time: Day 8Description: 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.
Measure: Serum tumor necrosis factor (TNF)-alfa Time: Day 3Description: 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.
Measure: Serum tumor necrosis factor (TNF)-alfa Time: Day 8Description: 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.
Measure: Serum interferon-gamma Time: Day 3Description: 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 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum interferon-gamma Time: Day 8Description: 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.
Measure: Serum monocyte chemoattractant protein (MCP)-1 Time: Day 3Description: 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 8; verified by the measurement of cytokines in patient serum by the ELISA technique; quantified by the absolute number between the two groups.
Measure: Serum monocyte chemoattractant protein (MCP)-1 Time: Day 8Description: 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 3; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Complete blood count Time: Day 3Description: 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.
Measure: Complete blood count Time: Day 8Description: 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.
Measure: C-reactive protein - absolute number Time: Day 3Description: 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.
Measure: C-reactive protein - absolute number Time: Day 8Description: 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 percentage between the two group.
Measure: C-reactive protein - percentage Time: Day 3Description: 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 percentage between the two groups.
Measure: C-reactive protein - percentage Time: Day 8Description: 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.
Measure: Adverse events - percentage Time: Day 8Description: 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 absolute number.
Measure: Adverse events - absolute number Time: Day8Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by absolute number.
Measure: Treatment discontinuation rate - absolute number Time: Day8Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by percentage.
Measure: Treatment discontinuation rate - percentage Time: Day8This is a randomised, multi-center, open label, adaptive, exploratory trial to assess the efficacy of two different drug regimens in terms of preventing symptomatic COVID-19 disease in healthcare workers at high risk of exposure to SARS-CoV-2. The trial will compare two different experimental medication arms to the control arm comprising the use of standard personal protective equipment (PPE) with no additional pharmacological intervention.
Description: Number of SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology.
Measure: Number of SARS-CoV-2 infections Time: 6 monthsDescription: Duration of symptoms for each symptomatic infection
Measure: Duration of symptoms Time: 6 monthsDescription: Maximum score on WHO Ordinal Scale for Clinical Improvement for each symptomatic infection. Score of 0 being uninfected and a score of 8 being dead.
Measure: Maximum score on WHO Ordinal Scale Time: 6 monthsDescription: Time to onset of SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology
Measure: Time to onset of SARS-CoV-2 infection Time: 6 monthsDescription: Number of symptomatic SARS-CoV-2 infection (COVID-19) confirmed by PCR and/or serology
Measure: Number of symptomatic SARS-CoV-2 infections Time: 6 monthsDescription: Number of asymptomatic • Asymptomatic SARS-CoV-2 infection suggested by serological outcome
Measure: Number of asymptomatic SARS-CoV-2 infections Time: 6 monthsDescription: Peak score on modified Flu-PRO during each symptomatic infection. 37-item questionairre assessing the severity of flu like symptoms one a scale of 0 - not at all to 5 - very much.
Measure: Peak score on modified Flu PRO Time: 6 monthsMulticenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: 500 Hospitalized patients with pneumonia derived from COVID-19 (Coronavirus Disease-19), either confirmed by RT-PCR (Real Time polymerase chain reaction), or suggested by typical findings on the computed tomography scan symptomatic. Experimental group: nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: placebo 8/8 hours for 5 days.
Description: Compare the intubation 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 14 days; verified by clinical evolution; quantified by percentage.
Measure: Orotracheal intubation rate Time: 14 daysDescription: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed free of mechanical ventilation, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
Measure: Mechanical ventilation free days Time: 14 daysDescription: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the hospital, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
Measure: Hospitalisation days Time: 14 daysDescription: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed at the ICU, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
Measure: ICU days Time: 14 daysDescription: Compare the number of days patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, stayed with the support of oxygen nasal cannula, in the period of 14 days; verified by clinical evolution; quantified by absolute number.
Measure: Intranasal oxygen support days Time: 14 daysDescription: Compare the mortality 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 14 days; verified by clinical evolution; quantified by absolute number.
Measure: Mortality rate Time: 14 daysDescription: 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 clinica data; quantified by the number of days that presented the symptom.
Measure: Days with fever Time: 14 daysDescription: Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.
Measure: Days with cough Time: 14 daysDescription: Reduction in the duration of dyspnea of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of clinica data; quantified by the number of days that presented the symptom.
Measure: Days with dyspnea Time: 14 daysDescription: Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations.
Measure: Radiologic findings Time: Day1Description: Compare chest tomographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of radiologic data; quantified by the number of patients that presented the a list of alterations.
Measure: Radiologic findings Time: Day7Description: Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations.
Measure: Cardiologic findings Time: Day1Description: Compare echocardiographic findings of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of echocardiographic data; quantified by the number of patients that presented the a list of alterations.
Measure: Cardiologic findings Time: Day7Description: 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 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: C-reactive protein - absolute number Time: Day 1Description: 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.
Measure: C-reactive protein serum levels Time: Day 3Description: 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 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: C-reactive protein serum levels Time: Day 7Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Lactate dehydrogenase (LDH) serum levels Time: Day 1Description: To evaluate the levels of lactate dehydrogenase (LDH) 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.
Measure: Lactate dehydrogenase (LDH) serum levels Time: Day 3Description: To evaluate the levels of lactate dehydrogenase (LDH) of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Lactate dehydrogenase (LDH) serum levels Time: Day 7Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Troponin serum levels Time: Day 1Description: To evaluate the levels of troponin 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.
Measure: Troponin serum levels Time: Day 3Description: To evaluate the levels of troponin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Troponin serum levels Time: Day 7Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Electrolytes serum levels Time: Day 1Description: To evaluate the levels of electrolytes 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.
Measure: Electrolytes serum levels Time: Day 3Description: To evaluate the levels of electrolytes of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Electrolytes serum levels Time: Day 7Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Glucose serum levels Time: Day 1Description: To evaluate the levels of glucose 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.
Measure: Glucose serum levels Time: Day 3Description: To evaluate the levels of glucose of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Glucose serum levels Time: Day 7Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Renal function Time: Day 1Description: To evaluate renal function 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.
Measure: Renal function Time: Day 3Description: To evaluate renal function of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Renal function Time: Day 7Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Coagulogram Time: Day 1Description: To evaluate coagulogram 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.
Measure: Coagulogram Time: Day 3Description: To evaluate coagulogram of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Coagulogram Time: Day 7Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Liver function panel Time: Day 1Description: To evaluate liver function panel 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.
Measure: Liver function panel Time: Day 3Description: To evaluate liver function panel of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Liver function panel Time: Day 7Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Ferritin Time: Day 1Description: To evaluate ferritin 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.
Measure: Ferritin Time: Day 3Description: To evaluate ferritin of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Ferritin Time: Day 7Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: D-dimer Time: Day 1Description: To evaluate D-dimer 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.
Measure: D-dimer Time: Day 3Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: D-dimer Time: Day 7Description: To evaluate blood cell count of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, for 7 days; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Blood cell count Time: 7 daysDescription: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 1; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Inflammatory mediators Time: Day 1Description: To evaluate D-dimer 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.
Measure: Inflammatory mediators Time: Day 3Description: To evaluate D-dimer of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide with patients with COVID-19 treated with placebo, on day 7; verified by laboratory tests and expressed by the absolute number between the two groups.
Measure: Inflammatory mediators Time: Day 7Description: 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.
Measure: Adverse events - percentage Time: Day 14Description: 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 absolute number.
Measure: Adverse events - absolute number Time: Day 14Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by absolute number.
Measure: Treatment discontinuation rate - absolute number Time: Day 14Description: Assess the rate of treatment discontinuation due to adverse events; verified by information actively collected from patients or family members; quantified by percentage.
Measure: Treatment discontinuation rate - percentage Time: Day 14New outpatient treatments for COVID-19 are urgently needed. There is some evidence that a combination of three medications currently used to treat other viral infections could be effective in fighting this new virus. The purpose of this trial is to evaluate the efficacy of Nitazoxanide (NTZ), Ribavirin (RBV) and Hydroxychloroquine (HCQ) versus placebo in participants with proven SARS-CoV-2 infection The study will enroll 70 participants within the 7 days after having been diagnosed with coronavirus infection. The purpose is to determine if those randomized to 5-day dosing with the three medication combination have decreased viral load and severity of illness in the 10 days following treatment as compared to those taking placebo. Participants will be actively followed for 28 days.
Description: qPCR measured via nasal swab
Measure: Rate of decline in viral load over the 10 days after randomization Time: 10 days after randomizationAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports