Covid 19 Research using Clinical Trials (Home Page)
Hydroxychloroquine SulfateWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (30)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug269 | Azithromycin Tablets Wiki | 0.39 |
| drug2871 | lopinavir/ritonavir Wiki | 0.28 |
| drug1945 | Public space exposure Wiki | 0.28 |
| drug959 | Folic Acid Wiki | 0.28 |
| drug2611 | Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures Wiki | 0.28 |
| drug405 | Bromhexine 8 MG Wiki | 0.28 |
| drug215 | Ascorbic Acid Wiki | 0.28 |
| drug1105 | Hydroxychloroquine Sulfate + Azithromycin Wiki | 0.28 |
| drug1391 | Low-dose radiotherapy Wiki | 0.28 |
| drug976 | GLS-1200 Wiki | 0.28 |
| drug1719 | Oxygen supply Wiki | 0.28 |
| drug2535 | Tocilizumab Injection [Actemra] Wiki | 0.28 |
| drug1171 | IgG test Wiki | 0.28 |
| drug2103 | Ritonavir/lopinavir Wiki | 0.28 |
| drug1106 | Hydroxychloroquine Sulfate + Azythromycin Wiki | 0.28 |
| drug3019 | survey work Wiki | 0.28 |
| drug1375 | Low Dose (10 mg) Control Wiki | 0.28 |
| drug1024 | HCQ & AZ Wiki | 0.28 |
| drug406 | Bromhexine Hydrochloride Wiki | 0.28 |
| drug1530 | Multivitamin Wiki | 0.28 |
| drug1726 | PB1046 Wiki | 0.28 |
| drug1386 | Low molecular weight heparin Wiki | 0.20 |
| drug1642 | Normal Saline Wiki | 0.20 |
| drug563 | Chloroquine Sulfate Wiki | 0.20 |
| drug670 | Corticosteroid Wiki | 0.20 |
| drug2121 | SAB-185 Wiki | 0.20 |
| drug262 | Azithromycin Wiki | 0.14 |
| drug1374 | Losartan Wiki | 0.10 |
| drug1860 | Placebos Wiki | 0.07 |
| drug1822 | Placebo Wiki | 0.05 |
Correlated MeSH Terms (20)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D011654 | Pulmonary Edema NIH | 0.28 |
| D000075902 | Clinical Deterioration NIH | 0.20 |
| D003428 | Cross Infection NIH | 0.16 |
| D008175 | Lung Neoplasms NIH | 0.14 |
| D013577 | Syndrome NIH | 0.12 |
| D003141 | Communicable Diseases NIH | 0.12 |
| D011665 | Pulmonary Valve Insufficiency NIH | 0.11 |
| D007239 | Infection NIH | 0.11 |
| D006333 | Heart Failure NIH | 0.10 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.08 |
| D055371 | Acute Lung Injury NIH | 0.08 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.08 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.07 |
| D018352 | Coronavirus Infections NIH | 0.07 |
| D007249 | Inflammation NIH | 0.06 |
| D011014 | Pneumonia NIH | 0.05 |
| D001008 | Anxiety Disorders NIH | 0.05 |
| D016638 | Critical Illness NIH | 0.04 |
| D011024 | Pneumonia, Viral NIH | 0.03 |
| D014777 | Virus Diseases NIH | 0.03 |
Correlated HPO Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100598 | Pulmonary edema HPO | 0.28 |
| HP:0100526 | Neoplasm of the lung HPO | 0.14 |
| HP:0010444 | Pulmonary insufficiency HPO | 0.11 |
| HP:0001635 | Congestive heart failure HPO | 0.10 |
| HP:0002090 | Pneumonia HPO | 0.05 |
There are 13 clinical trials
Clinical Trials
1 Norwegian Coronavirus Disease 2019 Study: An Open Labeled Randomized Controlled Pragmatic Trial to Evaluate the Antiviral Effect of Chloroquine in Adult Patients With SARS-CoV-2 Infection
In the current proposal, the investigators aim to investigate the virological and clinical effects of chloroquine treatment in patients with established COVID-19 in need of hospital admission. Patients will be randomized in a 1:1 fashion to standard of care or standard of care with the addition of therapy with chloroquine.
NCT04316377 Corona Virus Infection Drug: Hydroxychloroquine Sulfate MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases
Primary Outcomes
Description: Viral load assessed by real time polymerase chain reaction in oropharyngeal samples
Measure: Rate of decline in SARS-CoV-2 viral load Time: Baseline (at randomization) and at 96 hoursSecondary Outcomes
Description: National Early Warning Score score determines the degree of illness of a patient. Scores range from 0-20, with a higher score representing further removal from normal physiology and a higher risk of morbidity and mortality.
Measure: Change in National Early Warning Score score Time: Baseline (at randomization) and at 96 hoursDescription: Transfer from regular ward to intensive care unit during index admission
Measure: Admission to intensive care unit Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)Description: All-cause mortality during index admission
Measure: In-hospital mortality Time: At all times after randomization during index admission (between admission and discharge, approximately 21 days)Description: Total days admitted to the hospital (difference between admission date and discharge date of index admission)
Measure: Duration of hospital admission Time: During index admission (between admission and discharge, approximately 21 days)Description: All-cause mortality assessed at 30 and 90 days
Measure: Mortality at 30 and 90 days Time: At follow-up 30 and 90 daysDescription: Percentage of subjects reporting each severity rating on a 7-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized, but unable to resume normal activities Not hospitalized, with resumption of normal activities
Measure: Clinical status Time: 14 days after randomizationDescription: Change in C-reactive protein concentrations from randomization to 96 hours after randomization
Measure: Change in C-reactive protein concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in alanine aminotransferase concentrations from randomization to 96 hours after randomization
Measure: Change in alanine aminotransferase concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in aspartate aminotransferase concentrations from randomization to 96 hours after randomization
Measure: Change in aspartate aminotransferase concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in bilirubin concentrations from randomization to 96 hours after randomization
Measure: Change in bilirubin concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in estimated glomerular filtration rate from randomization to 96 hours after randomization
Measure: Change in estimated glomerular filtration rate Time: Baseline (at randomization) and at 96 hoursDescription: Change in cardiac troponin concentrations from randomization to 96 hours after randomization
Measure: Change in cardiac troponin concentrations Time: Baseline (at randomization) and at 96 hoursDescription: Change in natriuretic peptide concentrations from randomization to 96 hours after randomization
Measure: Change in natriuretic peptide concentrations Time: Baseline (at randomization) and at 96 hours2 Comparison Of Therapeutics for Hospitalized Patients Infected With SARS-CoV-2 In a Pragmatic aDaptive randoMizED Clinical Trial During the COVID-19 Pandemic (COVID MED Trial)
Although a number of therapeutics are being utilized by clinicians to treat patients with COVID-19, none have been systematically evaluated in clinical trials. Lopinavir/ritonavir, an antiretroviral medication, showed equivocal but possibly positive efficacy and safety in a RCT conducted in China and published in NEJM in March of 2020. Hydroxychloroquine, an antimalarial and anti-inflammatory medication, has shown potent antiviral activity in vitro and elimination of viral shedding in a small pilot clinical trial. Losartan, an angiotensin II receptor blocker (ARB), has theoretical benefit as SARSCoV-2 appears to bind to lung tissue via Angiotensin-Converting Enzyme 2 (ACE-2) receptors which might be inhibited by ARBs. This pragmatic adaptive trial compares outcome in COVID-19 patients treated with lopinavir/ritonavir, hydroxychloroquine, losartan, and placebo.
NCT04328012 SARS-CoV-2 Infection Drug: lopinavir/ritonavir Drug: Hydroxychloroquine Sulfate Drug: Losartan Drug: Placebos
Primary Outcomes
Description: difference in NCOSS scores between the different treatment groups
Measure: National Institute of Allergy and Infectious Diseases COVID-19 Ordinal Severity Scale (NCOSS) Time: 60 daysSecondary Outcomes
Description: difference in the total inpatient LOS between the four treatment groups
Measure: Hospital length of stay (LOS) Time: 60 daysDescription: difference in the total ICU level care LOS between the four treatment groups
Measure: Intensive care unit level LOS Time: 60 daysDescription: difference in length of use of mechanical ventilation between the four treatment groups
Measure: Mechanical ventilation Time: 60 daysDescription: difference in all cause mortality between the four treatment groups
Measure: survival Time: 60 days3 Efficacy of Hydroxychloroquine for Post-exposure Prophylaxis (PEP) to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Among Adults Exposed to Coronavirus Disease (COVID-19): a Blinded, Randomized Study
This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or clinically suspected COVID-19. Eligible participants will be enrolled and randomized to receive the intervention or placebo at the level of the household (all eligible participants in one household will receive the same intervention).
NCT04328961 COVID-19 Corona Virus Infection SARS (Severe Acute Respiratory Syndrome) SARS-CoV-2 Drug: Hydroxychloroquine Sulfate Drug: Ascorbic Acid MeSH:Infection Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome
Primary Outcomes
Description: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected daily for 14 days
Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection Time: Day 1 through Day 14 after enrolmentDescription: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection from self-collected samples collected at study exit
Measure: Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection Time: Day 28 after enrolmentSecondary Outcomes
Description: Safety and tolerability of Hydroxychloroquine as SARS-CoV-2 PEP in adults
Measure: Rate of participant-reported adverse events Time: 28 days from start of Hydroxychloroquine therapyDescription: PCR-confirmed COVID-19 diagnosis
Measure: Incidence rates of COVID-19 through study completion Time: 28 days from enrolment4 Open, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D5) and azithromycin (500 mg/ 5 days) to treat moderate to severe COVID-19 pneumonia.
NCT04329572 COVID-19 Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Tablets
Primary Outcomes
Description: Evaluation of change from baseline. Kaplan-meier method will be used.
Measure: Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability Time: 28 daysSecondary Outcomes
Description: Evaluation of change in viral load
Measure: Viral load Time: Day 6Description: Time for normalization of body temperature, respiratory rate and cough relief
Measure: Change in Clinical Condition Time: 28 daysDescription: Time to wean off oxygen supplementation and / or invasive / non-invasive ventilatory support;
Measure: Evolution of Acute Respiratory Syndrome Time: 28 daysDescription: Time to be discharged from hospital
Measure: Hospital discharge Time: 28 daysDescription: Evaluation of change in acute respiratory syndrome
Measure: Rate of mortality within 28-days Time: 28 days5 Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19
This is a three-arm randomized trial comparing the efficacy of single agent hydroxychloroquine to the combination of hydroxychloroquine and azithromycin, and to a delayed hydroxychloroquine regimen, which will serve as a contemporaneous Day 1-6 supportive care control, in eliminating detectable SARS-CoV-2 on day 6 following the initiation of treatment in order to determine which regimen is more effective.
NCT04336332 SARS-CoV-2 COVID-19 Combination Product: Hydroxychloroquine Sulfate + Azithromycin Drug: Hydroxychloroquine Sulfate
Primary Outcomes
Description: Will be assessed at day six compared to baseline between hydroxychloroquine sulfate alone and hydroxychloroquine sulfate plus azithromycin to treat COVID-19.
Measure: Changes in patients viral load Time: Baseline, day 3 and day 6Description: A second concurrent comparison will evaluate change in viral load at day 6 between hydroxychloroquine sulfate alone and supportive care.
Measure: Second evaluation of changes in patients viral load Time: Day 6Secondary Outcomes
Description: Time to resolution of symptoms
Measure: Symptom questionnaire Time: up to 6 monthsDescription: Change in the fever curve resulting in shorter time to afebrile for 48 hours
Measure: Fever assessment Time: up to 10 daysDescription: Body temperature will be measured in degrees Fahrenheit using an automated thermometer which will be provided to the patient 4 times per day.
Measure: Vital Signs - Body Temperature Time: up to 10 daysDescription: Time to discharge (If hospitalized)
Measure: Discharge Time: up to 6 monthsDescription: Time to recovery (back to school, work, etc)
Measure: Recovery Time: up to 6 monthsDescription: As measured by standard metrics
Measure: Assessment of agent toxicity Time: up to 10 daysDescription: Collection of Oropharynx swabs for viral load and microbiome analysis
Measure: Oropharynx swab sample collections Time: up to 10 daysDescription: Collection of blood for viral load and microbiome analysis
Measure: Blood Sample collections Time: up to 10 daysDescription: Decrease in virus shedding in nasopharyngeal secretions such as Ferritin, D-dimer, CRP, Troponin and LDH
Measure: Viral shedding assessment - nasopharyngeal secretions Time: up to 10 daysDescription: Decrease in virus shedding in serology such as Ferritin, D-dimer, CRP, Troponin and LDH
Measure: Viral shedding assessment - serology Time: up to 10 daysDescription: Measurement of cytokines in blood
Measure: Cytokines in blood Time: up to 10 days6 Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals (ELEVATE Trial)
This study will investigate the security and efficacy of a daily low dose of hydroxychloroquine, in preventing the development of the disease from COVID-19 in Health Care Workers at a National Institute of Health In Mexico City.
NCT04340349 Hydroxychloroquine Antimalarials Enzyme Inhibitors Antirheumatic Agents Drug: Hydroxychloroquine Sulfate Drug: Bromhexine 8 MG
Primary Outcomes
Description: https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, this scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".
Measure: Polymerase chain reaction assay (PCR) negative at day 0 plus negative serological panel for COVID-19 antibodies at enrolment. Time: Day 0Description: https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, this scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".
Measure: Polymerase chain reaction assay (PCR) negative at day 30. Time: Day 30Description: https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, this scale reflects a range from uninfected to dead, where 0 is "no clinical or virological evidence of infection", 1 is "no limitation of activities", 2 is "limitation of activities", 3 is "hospitalized, no oxygen therapy", 4 is "oxygen by mask or nasal prongs", 5 is "non-invasive ventilation or high-flow oxygen", 6 is "intubation and mechanical ventilation", 7 is "ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)", and 8 is "death".
Measure: Polymerase chain reaction assay (PCR) negative at day 60. Time: Day 607 WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection
This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.
NCT04341727 Coronavirus Infection Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Chloroquine Sulfate MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death
Measure: Hours to recovery Time: 42 daysSecondary Outcomes
Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications
Measure: Time fever resolution Time: 42 days8 Randomized Controlled Trial of Hydroxychloroquine Versus Placebo for the Treatment of Adult Patients With Acute Coronavirus Disease 2019 - COVID-19
The current outbreak of COVID-19 caused by SARS-CoV-2 is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>9500) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 replication and anecdotal reports from COVID-19 patients in China and France suggest that chloroquine or hydroxychloroquine is a good candidate for treatment. In the French study a favourable effect was seen when hydroxychloroquine was used together with azithromycin in a small series of COVID-19 patients. However, so far all published evidence is based on non-controlled use of hydroxychloroquine. We propose to conduct a placebo-controlled trial in COVID-19 patients with mild to moderate disease in Germany to assess virological efficacy, tolerability and safety of hydroxychloroquine in the treatment of COVID-19. The objective of this trial is to identify an effect of hydroxychloroquine on viral clearance in vivo. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post-exposure prophylaxis of COVID-19.
NCT04342221 COVID-19, Hydroxychloroquine Sulfate Drug: Hydroxychloroquine Sulfate Drug: Placebo
Primary Outcomes
Description: Viral clearance defined as time to sustained SARS-CoV-2-specific RNA copy number ≤100, measured by real time reverse-transcription polymerase chain reaction RT-PCR in throat swabs.
Measure: Effect of HCQ on in vivo viral clearance Time: 6 monthsOther Outcomes
Measure: In-hospital mortality Time: 60 daysMeasure: All-cause mortality Time: 60 days
Measure: Proportion requiring non-invasive or invasive ventilation Time: 6 months
Measure: Proportion admitted to ICU Time: 6 months
Measure: Duration of hospitalization Time: 6 months
Measure: Reduction in viral RNA load in upper respiratory tract specimen as assessed by area under viral load curve Time: 6 months
Measure: Reduction in viral RNA load in upper respiratory tract specimen defined as decline of RNA load by 2 log-levels or to below detection level Time: 6 months
9 Open Label, Multicentric, Non Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Mild Acute Respiratory Syndrome (COVID-19) Caused by SARS-CoV-2 Virus
This is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg BID on D1 and 400 mg/day on D2 to D7) and azithromycin (500 mg/ 5 days) to treat mild ambulatory COVID-19 patients.
NCT04348474 Covid-19 Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Tablets
Primary Outcomes
Description: Ordinal scale (7 points ordinal scale that measures illness severity over time)
Measure: Change in Clinical Condition Time: 28 daysSecondary Outcomes
Description: Number of patients that needed to be hospitalized
Measure: Hospitalization Time: 28 daysDescription: Time for normalization of body temperature
Measure: Change in Clinical Condition Time: 28 daysDescription: Time for normalization of of respiratory rate
Measure: Change in Clinical Condition Time: 28 daysDescription: Time for cough relief
Measure: Change in Clinical Condition Time: 28 daysDescription: Evaluation of change in acute respiratory syndrome
Measure: Rate of mortality within 28-days Time: 28 daysDescription: Subgroup analysis by comorbidities
Measure: Change in Clinical Condition related to comorbidity Time: 28 days10 Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial
This is a randomized trial for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in high-risk adults not requiring hospital admission.The overarching goal of this study is to assess the effectiveness of interventions on the incidence of lower respiratory tract infection (LRTI) progression among high-risk adult outpatients with SARS-CoV-2 infection to inform public health control strategies.
NCT04354428 COVID-19 SARS-CoV-2 Drug: Ascorbic Acid Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Folic Acid
Primary Outcomes
Description: Resting blood oxygen saturation (SpO2<93%) level sustained for 2 readings 2 hours apart and presence of subjective dyspnea or cough
Measure: Lower respiratory tract infection (LRTI) rates Time: 28 days from enrolmentDescription: Cumulative incidence of hospitalization or mortality
Measure: Incidence of hospitalization or mortality Time: Day 28 after enrolmentDescription: Time to clearance of nasal SARS-CoV-2, defined as 2 consecutive negative swabs
Measure: Change in upper respiratory viral shedding Time: Day 1 through Day 14 after enrolmentSecondary Outcomes
Description: Serious adverse events (including death and hospitalization) and adverse events resulting in treatment discontinuation
Measure: Rate of participant-reported adverse events Time: 28 days from enrolment11 Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)
The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.
NCT04361461 Coronavirus Infections SARS-CoV 2 SARS (Severe Acute Respiratory Syndrome) Pulmonary Disease Drug: Hydroxychloroquine Sulfate Drug: Hydroxychloroquine Sulfate + Azythromycin MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.
Measure: Individual response rate Time: 14 days after randomizationSecondary Outcomes
Description: All-cause mortality rates at Day 28th after randomization
Measure: All-cause mortality Time: 28 days after randomizationDescription: Number of days that the patient was on mechanical ventilation which was under ventilation from basal line
Measure: Duration of mechanical ventilation Time: baselineDescription: Proportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization.
Measure: Proportion of patients which needed mechanical ventilation during study Time: hospitalization within 28 daysDescription: The ordinal scale is an assessment of the clinical status at the first clinical evaluation in a clinical study. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Measure: World Health Organization (WHO) Ordinal scale Time: 28 days after inclusion and compared to baselineDescription: Length of hospital stay in days for hospitalization
Measure: Duration of hospitalization Time: hospitalization within 28 daysDescription: Rates of drug discontinuation in all causes under study
Measure: Rates of drug discontinuation Time: hospitalization within 28 daysOther Outcomes
Description: Rates of serious adverse events
Measure: Rates of serious adverse events Time: Day 14th12 Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk (PREVENT)
Few studies have reported the efficacy of HCQ in reducing the viral load and improving the severity of symptoms in hospitalized COVID-19 cases with serious respiratory infection. However, the prophylactic benefits of HCQ has not been clearly defined yet.
NCT04371926 COVID-19 Drug: Hydroxychloroquine Sulfate
Primary Outcomes
Description: Time to reach normal body temperature (TNBT), ≤37.50 C
Measure: Time to reach normal body temperature Time: 1 monthDescription: Development of fever and/or other symptoms of COVID-19 during the 1 month of the HCQ therapy
Measure: Development of COVID-19 symptoms during HCQ preventive therapy in staff Time: 1 monthSecondary Outcomes
Description: Viral RNA test results at day 6 will be compared between the HCQ vs no-HCQ group
Measure: COVID-19 test result at follow-up in patients Time: 6 daysDescription: Worsening of symptoms in COVID-19 patients requiring artificial ventilation during the study period
Measure: Worsening of symptoms in COVID-19 patients Time: 1 month13 Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study
Low radiation doses produce anti-inflammatory effects, which may be useful in the treatment of respiratory complications of COVID-19. This type of treatment is non-invasive and therefore, a priori, it can be used in all types of patients. Main objective: To evaluate the efficacy of low-dose lung irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to the pre baseline measurement. -irradiation.
NCT04380818 Pneumonia, Viral Radiation: Low-dose radiotherapy Drug: Hydroxychloroquine Sulfate Drug: Ritonavir/lopinavir Drug: Tocilizumab Injection [Actemra] Drug: Azithromycin Drug: Corticosteroid Drug: Low molecular weight heparin Device: Oxygen supply MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: To evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to baseline pre-irradiation measurement. .
In cases of impossibility the SaFiO2 will be determined
Measure: Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20% Time: Day 2 after interventional radiotherapy
Secondary Outcomes
Description: Lung toxicity measured according to CTCAEv5
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Time: Day 30 and day 90 after interventional radiotherapy
Description: Chest CT
Measure: Change of the radiological image Time: Days 7 and day 30 after interventional radiotherapy
Description: Death of any cause
Measure: Overall mortality Time: Day 15 and Day 30 after interventional radiotherapy
Description: Interleukins IL-6, IL-10, IL-1, IL-2, IL-8 (pg/ml)
Measure: Measure of pro-inflammatory interleukins Time: Days 1, day 4 and day 7 after interventional radiotherapy
Description: TGF-β (ng/ml)
Measure: Measure of trasforming growth factor (TGF-b) Time: Days 1, day 4 and day 7 after interventional radiotherapy
Description: TNF-α (pg/ml)
Measure: Measure of tumor necrosis factor alpha (TNF-a) Time: Days 1, day 4 and day 7 after interventional radiotherapy
Description: Overexpression of L-, E-, and P-selectin
Measure: Determining overexpression of pro-inflammatory selectin Time: Days 1, day 4 and day 7 after interventional radiotherapy
Description: Overexpression of ICAM-1, VCAM
Measure: Determining cell adhesion molecules (CAMs) Time: Days 1, day 4 and day 7 after interventional radiotherapy
Description: PON-1(paraoxonase and arylesterase activity) (IU/ml)
Measure: Measure of marker of oxidative stress PON-1 Time: Days 1, day 4 and day 7 after interventional radiotherapy
Related HPO nodes (Using clinical trials)
HP:0002090: Pneumonia
Genes 220
KMT2D OSTM1 GBA RSPH1 DOCK8 NKX2-1 RNU4ATAC SPAG1 RAG1 MCIDAS AFF4 TNFRSF13C DNAH1 NOTCH3 CD19 ALMS1 NADK2 UNC119 SFTPC FOXN1 CD79B CFAP221 CD81 SAMD9 MED25 ZAP70 RAG2 IGLL1 DNAAF1 RPGR STK36 LTBP3 PLOD1 DNAH9 BTK TERT COL11A2 OFD1 TNFRSF11A LRBA RSPH4A CD19 NME8 SMARCD2 GAS8 CFTR TNFRSF13B CCDC65 CFAP298 COL11A2 RAG1 ORC6 P4HTM MAN2B1 CFAP300 JAK3 CACNA1C ICOS SETBP1 TNFRSF13C SPEF2 LIG4 NIPBL STAT3 ZMYND10 IL7R MAN2B1 HLA-DQA1 IL21R SELENON SP110 ACADVL CCDC39 ARMC4 NSMCE3 NFIX DNAI2 ACP5 PTPRC ZAP70 KIAA0586 FCGR2A NFKB2 NEK10 MTHFD1 EGFR RYR1 ADA DNAI1 TGFB1 DNAAF6 IL2RG KCNJ6 DCLRE1C CCDC103 IGHM GNPTAB DNAAF4 PNP CFB DCLRE1C TAF1 CARD11 USB1 ADA ICOS FMO3 IL2RG HLA-DQB1 GFI1 SFTPA2 ICOS CD3D FOXJ1 CRLF1 ELANE IL2RG SRP54 NFKB1 PANK2 GAS2L2 CD247 IRF8 GAS8 RAG2 CCDC151 WAS ZBTB24 CD3E DNAL1 EXTL3 SLC35A1 NCF1 TK2 MS4A1 IFNGR1 RNF168 RMRP RSPH9 NHLRC1 MUC5B TNFRSF13C DNAH5 DNMT3B RNF125 EPM2A TTC12 JAK3 LEP RAC1 CYBA PGM3 NOS1 DDR2 AFF4 TBC1D24 CHD7 TNFRSF13B OFD1 DNAI1 RANBP2 TCIRG1 DNAJB13 CR2 CCDC40 IL2RG NCF2 RAG2 SLC25A24 SGCG WDR19 FOXP3 RNU4ATAC ACTA1 UBB CFAP410 BTK TTC25 CARD11 DNAAF2 CXCR4 MASP2 DRC1 TBCD DCLRE1C CYBB RSPH3 LRRC6 PIGN TNFSF12 DNAAF5 CCNO CSPP1 CR2 SLC35C1 HYDIN TIMM8A NBN NFKB2 CCDC114 CASP8 ADA IL7R CCDC114 TNFSF12 BTK LRRC56 PEPD BLNK CD55 GRHL3 NBN PRKCD KPTN PMM2 DNAAF3 KDM6A POLA1 RAG1 DNAH11 SNP 0
Primary Outcomes
Description: To evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PAFI O2 by 20% measured 48h after treatment with respect to baseline pre-irradiation measurement. . In cases of impossibility the SaFiO2 will be determined
Measure: Efficacy of low-dose pulmonary irradiation assessed by change in PAFI O2 by 20% Time: Day 2 after interventional radiotherapySecondary Outcomes
Description: Lung toxicity measured according to CTCAEv5
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Time: Day 30 and day 90 after interventional radiotherapyDescription: Chest CT
Measure: Change of the radiological image Time: Days 7 and day 30 after interventional radiotherapyDescription: Death of any cause
Measure: Overall mortality Time: Day 15 and Day 30 after interventional radiotherapyDescription: Interleukins IL-6, IL-10, IL-1, IL-2, IL-8 (pg/ml)
Measure: Measure of pro-inflammatory interleukins Time: Days 1, day 4 and day 7 after interventional radiotherapyDescription: TGF-β (ng/ml)
Measure: Measure of trasforming growth factor (TGF-b) Time: Days 1, day 4 and day 7 after interventional radiotherapyDescription: TNF-α (pg/ml)
Measure: Measure of tumor necrosis factor alpha (TNF-a) Time: Days 1, day 4 and day 7 after interventional radiotherapyDescription: Overexpression of L-, E-, and P-selectin
Measure: Determining overexpression of pro-inflammatory selectin Time: Days 1, day 4 and day 7 after interventional radiotherapyDescription: Overexpression of ICAM-1, VCAM
Measure: Determining cell adhesion molecules (CAMs) Time: Days 1, day 4 and day 7 after interventional radiotherapyDescription: PON-1(paraoxonase and arylesterase activity) (IU/ml)
Measure: Measure of marker of oxidative stress PON-1 Time: Days 1, day 4 and day 7 after interventional radiotherapy