Name (Synonyms) | Correlation | |
---|---|---|
drug115 | Azithromycin Tablets Wiki | 0.43 |
drug81 | ArtemiC Wiki | 0.30 |
drug445 | Folic Acid Wiki | 0.30 |
drug1005 | Saline Nasal Irrigation Wiki | 0.30 |
drug83 | Ascorbic Acid Wiki | 0.30 |
drug470 | HCQ & AZ vs HCQ+SIR Wiki | 0.30 |
drug195 | CAStem Wiki | 0.30 |
drug148 | Best Supportive Care Wiki | 0.30 |
drug615 | Ivermectine Wiki | 0.30 |
drug357 | DeltaRex-G Wiki | 0.30 |
drug1245 | Whole Exome Sequencing Wiki | 0.30 |
drug1330 | lopinavir/ritonavir Wiki | 0.30 |
drug1201 | Ulinastatin Wiki | 0.30 |
drug945 | Ravulizumab Wiki | 0.30 |
drug524 | Hydroxychloroquine Sulfate + Azithromycin Wiki | 0.30 |
drug525 | Hydroxychloroquine Sulfate + Azythromycin Wiki | 0.30 |
drug1007 | Saline with Baby Shampoo Nasal Irrigation Wiki | 0.30 |
drug1389 | risk factors Wiki | 0.30 |
drug111 | Azithromycin 500 mg Wiki | 0.30 |
drug264 | Chloroquine Sulfate Wiki | 0.21 |
drug872 | Placebos Wiki | 0.15 |
drug650 | Losartan Wiki | 0.11 |
drug108 | Azithromycin Wiki | 0.11 |
drug923 | Questionnaire Wiki | 0.10 |
drug850 | Placebo Wiki | 0.08 |
Name (Synonyms) | Correlation | |
---|---|---|
D007153 | Immunologic Deficiency Syndromes NIH | 0.17 |
D055371 | Acute Lung Injury NIH | 0.16 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.15 |
D055370 | Lung Injury NIH | 0.15 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.13 |
D007239 | Infection NIH | 0.13 |
D003141 | Communicable Diseases NIH | 0.13 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.13 |
D013577 | Syndrome NIH | 0.12 |
D018352 | Coronavirus Infections NIH | 0.10 |
D011024 | Pneumonia, Viral NIH | 0.09 |
D016638 | Critical Illness NIH | 0.06 |
D011014 | Pneumonia NIH | 0.05 |
D014777 | Virus Diseases NIH | 0.04 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002721 | Immunodeficiency HPO | 0.17 |
HP:0002090 | Pneumonia HPO | 0.05 |
There are 11 clinical trials
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.
Description: Viral load assessed by real time polymerase chain reaction in nasopharyngeal samples
Measure: Rate of decline in SARS-CoV-2 viral load Time: Baseline (at randomization) and at 96 hoursDescription: 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 6-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
Measure: Clinical status Time: 14 days after randomizationAlthough 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.
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 daysDescription: 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 daysThis 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).
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 enrolmentDescription: 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 enrolmentThis 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.
Description: Evaluation of change from baseline. Kaplan-meier method will be used.
Measure: Evolution of acute respiratory syndrome, oxygen saturation hemodynamic stability Time: 28 daysDescription: 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 daysThis 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.
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 6Description: 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 daysThis 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.
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 daysDescription: 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 daysThe 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.
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 monthsComparing the efficacy and safety of adjuvant use of Ivermectin in covid19 patients with pneumonia using Ivermectin with hydroxychloroquine compared to HCQ
Description: Number of patients cured assessed by Nasopharyngeal swab, oropharyngeal swab, and blood aspiration for covid19 (PCR) in addtion to Chest xary
Measure: Number of cured patients Time: 2 weeksDescription: Adverse events are assessed by Complete blood count (CBC), Liver function tests (ALT, AST),Renal function tests (blood urea, serum creatinine) and Fasting blood sugar test
Measure: Number of participants with treatment-related adverse events Time: 2 weeksThis 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.
Description: Ordinal scale (7 points ordinal scale that measures illness severity over time)
Measure: Change in Clinical Condition Time: 28 daysDescription: 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 daysThis 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.
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 enrolmentDescription: 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 enrolmentThe 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.
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 randomizationDescription: 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 daysDescription: Rates of serious adverse events
Measure: Rates of serious adverse events Time: Day 14th