Name (Synonyms) | Correlation | |
---|---|---|
drug591 | Hydroxychloroquine Wiki | 0.38 |
drug1255 | SivoMixx (200 billion) Wiki | 0.27 |
drug1507 | Zinc Sulfate Wiki | 0.27 |
drug1567 | hydroxychloroquine Wiki | 0.22 |
drug1442 | Umbilical Cord Mesenchymal Stem Cells Wiki | 0.19 |
drug754 | Lopinavir 200Mg/Ritonavir 50Mg Tab Wiki | 0.19 |
drug380 | Corticosteroid injection Wiki | 0.19 |
drug448 | ECCO2R Wiki | 0.19 |
drug1662 | standard procedure Wiki | 0.19 |
drug390 | Cytokine Adsorption Wiki | 0.19 |
drug68 | Alteplase 50 MG [Activase] Wiki | 0.19 |
drug1541 | consultation Wiki | 0.19 |
drug689 | Interferon-Beta Wiki | 0.19 |
drug867 | NaCl 0.9% Wiki | 0.19 |
drug1342 | TD-0903 Wiki | 0.19 |
drug18 | 2: Placebo Comparator Wiki | 0.19 |
drug294 | Cell therapy protocol 2 Wiki | 0.19 |
drug750 | Lopinavir / Ritonavir Pill Wiki | 0.19 |
drug1015 | Piperacillin/tazobactam Wiki | 0.19 |
drug1288 | Standard of care management Wiki | 0.19 |
drug588 | Hydoxychloroquine or Chloroquine Wiki | 0.19 |
drug1075 | Prevalence of COVID-19 Wiki | 0.19 |
drug537 | Gargle/Mouthwash Wiki | 0.19 |
drug67 | Alteplase 100 MG [Activase] Wiki | 0.19 |
drug1553 | eculizumab Wiki | 0.19 |
drug769 | Low molecular weight heparin Wiki | 0.19 |
drug725 | Ketamine Wiki | 0.19 |
drug379 | Corticosteroid Wiki | 0.19 |
drug871 | Naltrexone Wiki | 0.19 |
drug424 | Dexmedetomidine Injectable Product Wiki | 0.19 |
drug1682 | ventilatory support with oxygen therapy Wiki | 0.19 |
drug293 | Cell therapy protocol 1 Wiki | 0.19 |
drug959 | Oxygen-ozone therapy, probiotic supplementation and Standard of care Wiki | 0.19 |
drug1443 | Umbilical cord Wharton's jelly-derived human Wiki | 0.19 |
drug120 | Aviptadil (VIP) Wiki | 0.19 |
drug552 | HCQ & AZ Wiki | 0.19 |
drug541 | Gimsilumab Wiki | 0.19 |
drug524 | Folic Acid Wiki | 0.19 |
drug1440 | Ultra-Low-dose radiotherapy Wiki | 0.19 |
drug10 | 1: ILT101 Wiki | 0.19 |
drug1148 | Remestemcel-L Wiki | 0.13 |
drug1160 | Rifampin Wiki | 0.13 |
drug310 | Chloroquine Sulfate Wiki | 0.13 |
drug1367 | Telmisartan Wiki | 0.13 |
drug757 | Lopinavir-Ritonavir Wiki | 0.13 |
drug440 | Dornase Alfa Inhalation Solution [Pulmozyme] Wiki | 0.13 |
drug1402 | Tocilizumab Wiki | 0.13 |
drug608 | Hydroxychloroquine Sulfate Wiki | 0.12 |
drug505 | Favipiravir Wiki | 0.11 |
drug1504 | Zinc Wiki | 0.11 |
drug442 | Doxycycline Wiki | 0.11 |
drug1302 | Standard treatment Wiki | 0.11 |
drug1042 | Placebos Wiki | 0.10 |
drug889 | Nitazoxanide Wiki | 0.09 |
drug100 | Ascorbic Acid Wiki | 0.09 |
drug952 | Oseltamivir Wiki | 0.08 |
drug1476 | Vitamin D Wiki | 0.08 |
drug1035 | Placebo oral tablet Wiki | 0.08 |
drug1220 | Sarilumab Wiki | 0.08 |
drug1475 | Vitamin C Wiki | 0.08 |
drug1016 | Placebo Wiki | 0.07 |
drug715 | Ivermectin Wiki | 0.07 |
drug308 | Chloroquine Wiki | 0.07 |
drug370 | Convalescent plasma Wiki | 0.06 |
drug1280 | Standard of Care Wiki | 0.06 |
drug760 | Lopinavir/ritonavir Wiki | 0.06 |
drug1285 | Standard of care Wiki | 0.05 |
Name (Synonyms) | Correlation | |
---|---|---|
D055371 | Acute Lung Injury NIH | 0.34 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.31 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.29 |
D013577 | Syndrome NIH | 0.21 |
D003967 | Diarrhea NIH | 0.19 |
D000071257 | Emergence Delirium NIH | 0.19 |
D055370 | Lung Injury NIH | 0.17 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.14 |
D012598 | Scoliosi NIH | 0.13 |
D003693 | Delirium NIH | 0.13 |
D009103 | Multiple Sclerosis NIH | 0.13 |
D018352 | Coronavirus Infections NIH | 0.11 |
D014947 | Wounds and Injuries NIH | 0.11 |
D004417 | Dyspnea NIH | 0.08 |
D011024 | Pneumonia, Viral NIH | 0.08 |
D011014 | Pneumonia NIH | 0.07 |
D007249 | Inflammation NIH | 0.06 |
D003141 | Communicable Diseases NIH | 0.06 |
D007239 | Infection NIH | 0.05 |
D014777 | Virus Diseases NIH | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002014 | Diarrhea HPO | 0.19 |
HP:0002098 | Respiratory distress HPO | 0.08 |
HP:0002090 | Pneumonia HPO | 0.07 |
There are 28 clinical trials
Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central nervous system (CNS). The etiology of MS is unknown, although the immune system appears to play a role. Many different infectious agents have been proposed as potential causes for MS, including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS of MS patients. These findings have been replicated in part by other laboratories. The purpose of the current study is to test whether antibiotic treatment aimed at eradicating Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these criteria will be randomized to either placebo or antibiotic therapy, and followed for 6 months on treatment.
This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.
Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".
Measure: Categorization of hospitalization status Time: 14 daysDescription: Delta PaO2 measured in arterial puncture
Measure: Change in patient's oxygen partial pressure Time: 4 daysDescription: Delta PaCO2 measured in arterial puncture
Measure: Change in patient's carbondioxid partial pressure Time: 4 daysDescription: pH measured in arterial puncture
Measure: Level of pH in blood Time: 4 daysACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.
Description: In outpatients with COVID-19, the occurrence of hospital admission or death
Measure: Outpatients: Hospital Admission or Death Time: Up to 6 weeks post randomizationDescription: Patients intubated or requiring imminent intubation at the time of randomization will only be followed for the primary outcome of death.
Measure: Inpatients: Invasive mechanical ventilation or mortality Time: Up to 6 weeks post randomizationCOVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality. Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.
This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.
Description: All-cause hospitalization or emergency room stay of >24 hours
Measure: Hospitalization Time: 14 daysDescription: Viral load by self-collected nasal swab
Measure: Viral load Time: 3 daysDescription: Viral load by self-collected saliva swab
Measure: Viral load Time: 3 daysDescription: All-cause mortality
Measure: Mortality Time: 14 daysDescription: Proportion of participants experiencing adverse events, including gastrointestinal side effects and rash
Measure: Adverse events Time: 3 daysDescription: Prevalence of positive SARS-CoV-2 test by self-collected nasal swab
Measure: Positive SARS-CoV-2 test - nasal swab Time: 3 daysDescription: Prevalence of positive SARS-CoV-2 test by self-collected saliva swab
Measure: Positive SARS-CoV-2 test - saliva swab Time: 3 daysDescription: Prevalence of positive SARS-CoV-2 test by self-collected rectal swab
Measure: Positive SARS-CoV-2 test - rectal swab Time: 3 daysDescription: Prevalence of genetic macrolide resistance determinants by self-collected rectal swab
Measure: Genetic macrolide resistance determinants Time: 3 daysDescription: Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms
Measure: COVID-19 symptoms Time: 3, 7, 14, 21 daysDescription: Number of emergency room visits <24 hours
Measure: Number of emergency room visits Time: 14 daysDescription: Number of household members with confirmed or symptomatic COVID-19
Measure: Number of household members with COVID-19 (confirmed or symptomatic) Time: 14 daysDescription: Deaths within the study will be attempted to be matched with the US National Death Index
Measure: Death Time: 21 daysThis study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.
Description: Admitted to a hospital (not merely kept for emergency room observation)
Measure: Hospitalization within 14 days of enrollment Time: From enrollment to 14 days after enrollmentDescription: Hospital-free days at 28 days (number of days patient not in hospital); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score
Measure: Hospital-free days at 28 days Time: Admission (day 1) to 28 days after admission (day 28)Description: Ventilator-free days at 28 days (number of days patient not on a ventilator); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score
Measure: Ventilator-free days at 28 days Time: Admission (day 1) to 28 days after admission (day 28)Description: ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score
Measure: ICU-free days at 28 days Time: Admission (day 1) to 28 days after admission (day 28)This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR
Measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy Time: 12 weeksDescription: Reduction and/or progression of symptomatic days, reduction of symptom severity
Measure: Reduction or Progression of Symptomatic Days Time: 12 weeksDescription: Assess the symptom response to study therapy as measured by the survey in the EDC
Measure: Assess the safety of Quintuple Therapy Time: 12 weeksDescription: Pulse from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via pulse Time: 12 weeksDescription: Oxygen saturation from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via oxygen saturation Time: 12 weeksDescription: EKG response from baseline to 12 weeks
Measure: Assess the safety of Quintuple Therapy via EKG Time: 12 weeksDescription: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
Measure: Assess Tolerability of Quintuple Therapy Time: 12 weeksThis is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin
Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. 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 measured at 14 days after enrollment Time: Day 14Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. 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: WHO ordinal scale measured at 28 days after enrollment Time: Day 28To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).
Description: The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of < 150 i.u
Measure: Laboratory Result Time: Day 07 on follow-upDescription: The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below: Not hospitalized, able to resume normal activities Not hospitalized, but unable to resume normal activities Hospitalization, not requiring supplemental oxygen Hospitalization, requiring supplemental oxygen Hospitalization, requiring noninvasive mechanical ventilation Hospitalization, requiring invasive mechanical ventilation Death
Measure: Clinical Outcome Time: Day 07 on follow-upTrial design: Prospective, multi-centre, randomised, pragmatic, double blind trial Methods: Participants: Adult (>18 years) within 24 hours of admission to intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria: symptoms of febrile disease for ≥1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, incl. long QT syndromes, participation in another outcome-based interventional trial within last 30 days, patients taking Hydrochloroquine for other indication than COVID-19, pregnancy. Interventions: Patients will be randomised in 1:1:1 ratio to receive Hydrochloroquine 800mg orally in two doses followed by 400mg daily in two doses and Azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or Hydrochloroquine+ placebo (HC group) or placebo + placebo (C-group) in addition to best standard of care, which may evolve during the trial period but will not differ between groups. Objective: To test the hypothesis that early administration of combination therapy slows disease progression and improves mechanical-ventilation free survival. Outcomes: Primary outcome: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14. Secondary outcomes: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline. ICU-LOS D28 and D 90 mortality (in hospital) Tertiary (exploratory) outcomes: Viral load at D7 of study enrolment (No of viral RNA copies/ml of blood), proportion of patients alive and rtPCR negative from nasal swab at D14, Difference of FiO2 requirement and respiratory system compliance between day 0 and 7. Randomization: In 1:1:1 ratio and stratified according to study centre and patients age (cut-off 70 years) Blinding (masking): Patients, treating clinicians, outcome assessors and data analyst will be blinded to study treatment allocation. Unblinded study pharmacist or research nurse will prepare investigational products.
Description: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14.
Measure: Proportion of alive patients free off mechanical ventilation Time: 14 days after enrolmentDescription: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline.
Measure: Proportion of patients who avoided the need of mechanical ventilation Time: 14 daysDescription: Length of stay in intensive care unit
Measure: ICU LOS Time: 28 daysDescription: Proportion of patients who died by day 28
Measure: Mortality28 Time: 28 daysDescription: Proportion of patients who died by day 90
Measure: Mortality90 Time: 90 daysTo determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A). To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).
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.
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 overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with moderate, severe pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering investigational treatments administration to patients enrolled in the CORIMUNO-19 cohort (NCT04324047). Sarilumab+Azithromycin+Hydroxychloroquine, or Sarilumab only will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation. All patients will receive standard of care along with randomized investigational treatments. Outcomes of included patients will be compared between groups as well as with outcomes of patients in the CORIMUNO-19 cohort treated with other immune modulators or standard of care.
Description: Events considered are: need for ventilation (including invasive and non invasive ventilation), transfer to the Intensive Care Unit, death or new do-not-resuscitate (DNR) decision in the absence ventilation and outside ICU.
Measure: Need for ventilation (including invasive and non invasive ventilation), intensive care or death Time: 14 daysDescription: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: Early improvement: OMS progression scale <= 5 Time: 4 daysDescription: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: OMS progression scale Time: 4, 7 and 14 daysDescription: Overall survival
Measure: Survival Time: 14, 28 and 90 daysDescription: Number of ICU-free days alive
Measure: ICU-free days alive Time: 14, 28 and 90 daysDescription: Number of ventilation(invasive or non invasive)-free days alive
Measure: Ventilation-free days alive Time: 14 and 28 daysDescription: Number of hospital-free days alive
Measure: Hospital-free days alive Time: 14, 28 and 90 daysDescription: Number of oxygen therapy-free days alive
Measure: Oxygen therapy-free days alive Time: 14 and 28 daysDescription: SARS-CoV-2 viral load measurement by rtPCR
Measure: Time to negative viral excretion Time: 90 daysDescription: Immunophenotyping and multiplex cytokines (blood sample)
Measure: Immunophenotyping and multiplex cytokines Time: 8 daysThis study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.
Description: ordinal outcome of most severe a patient experienced after inpatient admission
Measure: Most severe outcome Time: 5 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 enrolmentIntroduction: The COVID-19 pandemic is characterized by significant morbidity and mortality. It is caused by a novel coronavirus with no current specific prevention nor treatment therapies. Treatments have been administered to patients with COVID-19 in order to control viral infection, among them: Chloroquine (CQ) and Hydroxychloroquine (HCQ), Lopinavir/Ritonavir (Lop/r), Remdesivir, Favipavir, acting over bacterial co-infection Azithromycin (Azithro), or modifying the inflammatory response of the host (Tocilizumab). Clinical trials offer conflicting evidence regarding the effectiveness and safety of therapies The real effectiveness and safety profile of the treatments for COVID-19 remains unknown. Objective: Evaluate the effectiveness and safety of pharmacological therapies used to treat adult patients with COVID-19. Methods: Pragmatic randomized controlled trial. Study population: Adults aged 18 years or over with a positive real-time polymerase chain reaction (RT-PCR) for Severe Acute Respiratory Syndrome CoV-2 (SARS CoV-2) and diagnosis of mild, severe or critical pneumonia, requiring hospital management at six hospitals in Colombia. Exclusion criteria: Pregnancy, known allergy to treatment, cirrhosis or hepatic abnormality (transaminases greater than 5 reference values), prolonged QT interval, glomerular filtration rate lesser than 30 ml/min/1.73m^2, history of lung fibrosis, advanced or metastatic cancer. Sample size: 1,600 participants. The study will be carried out in two phases. The first phase will be conducted with 480 participants and aims to identify treatments with higher or minimum potential, discontinue treatments with higher toxicity and have opportunity of introducing new treatments with potential efficacy. The second phase will be conducted with 1,120 participants to evaluate the effectiveness of the selected treatments. Four interventions have been defined: I1 HCQ, I2 HCQ plus Lop/r, I3 HCQ plus Azithro and I4 standard treatment. Within each institution, participants will be randomly assigned to one of the treatment arms assigned to that institution. Concealment will be kept through a central telephone. Treatment administration will be open. Variables: Sociodemographic and clinical at recruitment; (comorbidities, need for therapeutic support , grade of invasion at admission). Primary outcomes. Effectiveness: Mortality. Safety: Serious adverse events (AE) assessed by the NCI Community Oncology Research Program (NCORP) Guidance for Collection of Adverse Events Related to COVID-19 Infection. Secondary outcomes: Intensive care unit (ICU) admission, requirement of respiratory support, time to death, number of participants cured, any adverse event related to treatment. Analysis: Descriptive for the presentation of summary measures of the basal conditions by type of variable. Bivariate. Description of the basal conditions (with organic failure at admission, without failure at admission), by type of treatment, by participating institution. Description of crude effectiveness and safety by means of the difference of accumulated incidences, each one with 95% confidence intervals (95% CI) Intention to treat analyisis will be done. Adjusted analysis: The ratio and difference of cumulative incidences of mortality at 7 and 28 days and severe adverse events between treatments will be estimated, adjusting for confounding variables using logistic regression models with mixed effects considering each institution as a level or from equations. generalized estimation (GEE). Ethical considerations: The study has a risk beyond minimum according to the Resolution 8430/1993 of the Colombian Ministry of Health. Informed consent will be explained and signed if the patient is in condition to do so. This protocol will undergo evaluation by the ethics committee at each of the participating institutions and at the National University of Colombia. The protocol follows the Helsinki Declaration and institutional protocols for clinical investigation.
Description: Cumulative incidence
Measure: Mortality Time: Post-intervention at day 28Description: Number of participants that develop severe adverse events related to the treatment
Measure: Number of Participants with Treatment Related Severe Adverse Events as Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection Time: Post-intervention at day 28Description: Cumulative incidence
Measure: Mortality Time: Post-intervention at day 7Description: Number of participants that develop severe adverse events related to the treatment
Measure: Number of Participants with Treatment Related Severe Adverse Events as Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection Time: Post-intervention at day 7Description: Time from the date of assignment until the date of death from any cause
Measure: Time to death Time: Assessed up to 28 days postinterventionDescription: Number of Participants that require management in the ICU
Measure: Number of Participants that are transferred to the Intensive Care Unit (ICU) Time: Post-intervention at day 28Description: Participants requiring invasive mechanical ventilation
Measure: Number of Participants that need Mechanical Ventilation Support with endotracheal intubation. Time: Up to 28 days after hospital admissionDescription: Number of participants cured assessed RT-PCR for SARS CoV-2, without clinical symptoms and no radiological signs assessed by chest X ray
Measure: Number of participants Cured assessed by Nasopharyngeal swab, oropharyngeal swab, and blood aspiration for COVID19 (RT-PCR) without clinical symptoms and normal chest X ray Time: Up to 28 days after hospital admissionDescription: Any adverse event
Measure: Number of Participants with Any Adverse Event Related to Treatment Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection Time: Up to 28 days after hospital admissionDescription: Interim assessment of safety, which will be conducted after 480 participants are recruited. It will be evaluated through absolute frequency of severe AE and relative frequency measurements (proportion of total number of participants with severe adverse events divided by the total number of participants treated). It aims to aid the decision of excluding an active treatment arm should that arm have more than 3 serious adverse events in the first 30 participants or a serious adverse events incidence of 10 percent or higher.
Measure: Severe Adverse events Time: Up to 28 days after hospital admissionDescription: Interim assessment of minimum effectiveness, which will be conducted after 480 participants are recruited. It will be evaluated through relative frequency measurements (mortality proportion at 28 days of treatment). It aims to aid the decision of excluding an active treatment arm should that treatment arm have an efficacy lower than 0.2, calculated through futility analysis that assumes an expected difference of 10 percent at the end of the first phase of the study. For all the tests carried out in the interim analysis, the correction of the type I error will be made using the O'Brien-Fleming method.
Measure: Mortality Time: Up to 28 days after hospital admissionThe present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
Description: Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.
Measure: Time to clinical improvement Time: From date of randomization until 14 days later.Description: If the patient dies, we have reached an outcome.
Measure: Mortality Time: From date of randomization until 14 days later.Description: Pulse-oxymetry
Measure: SpO2 Improvement Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.Description: Incidence of new mechanical ventilation use (Rate)
Measure: Incidence of new mechanical ventilation use Time: From date of randomization until 14 days later.Description: Duration of hospitalization (Days)
Measure: Duration of hospitalization Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.Description: With incidence of any serious adverse effects, the outcome has happened.
Measure: Cumulative incidence of serious adverse events Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.In November 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients who died most often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%). These elderly patients with COVID19 are therefore very fragile and require treatment that fights the virus but is also adapted to their state of health and age. Most of current therapeutic trials worldwide exclude people aged over 75 years, which is precisely the age group affected by COVID19. We therefore propose to carry out a therapeutic trial specific to the elderly with drugs at doses that are bearable for these patients. Using the WHO, clinicaltrial, pubmed and the Chinese CCDC/CHCTR websites to find the better drugs adapted to elderly people, we decided after concertation between infectiologists and geriatricians to do a four arms clinical trial during two weeks twice a day: Hydroxychloroquine 200mg, Telmisartan 40mg, Azithromycin 250mg and standard care. We therefore hypothesize that one or more of these treatments may have a beneficial effect in controlling COVID19, without major and repeated side effects in elderly patients.
We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.
COVID-19 is a respiratory disease due to a novel coronavirus (SARS-CoV-2) that causes substantial morbidity and mortality. To date, no treatment has been proved to be effective in COVID-19. Elderly patients and patients with comorbidities have the worse prognosis with a higher risk of hospitalization, ICU admission and death. The efficacy of an early outpatient treatment could be suggested but need to be confirmed. This confirmation is mandatory to improve prognosis of COVID-19 but also to avoid unsuspected deleterious effect of drugs already used in clinical practice but not based on evidence.
Description: Hospitalization at D20
Measure: Hospital admission Time: Day 20Description: This outcome corresponds to the number of patients who died on day 20.
Measure: Effect of treatment on Death at D20 Time: Day 20Description: This outcome corresponds to the number of patients who died on day 60.
Measure: Effect of treatment on Death at D60 Time: Day 60Description: This outcome corresponds to the number of patients who died due to COVID on day 20.
Measure: Effect of treatment on Death due to COVID at D20 Time: Day 20Description: This outcome corresponds to the number of patients who died due to COVID on day 60.
Measure: Effect of treatment on Death due to COVID at D60 Time: Day 60Description: This outcome corresponds to the number of participants who need ICU stay at day 20.
Measure: Effect of treatment on need for ICU stay at D20 Time: Day 20Description: This outcome corresponds to the number of participants who need ICU stay at day 60.
Measure: Effect of treatment on need for ICU stay at D60 Time: Day 60Description: This outcome evaluates the duration of patient's ICU stay at day 20.
Measure: Effect of treatment on duration of ICU stay at D20 Time: Day 20Description: This outcome evaluates the duration of patient's ICU stay at day 60.
Measure: Effect of treatment on duration of ICU stay at D60 Time: Day 60Description: This outcome corresponds to the number of participants who need mechanical ventilation at D20.
Measure: Effect of treatment on need of mechanical ventilation at D20 Time: Day 20Description: This outcome corresponds to the number of participants who need mechanical ventilation at D60.
Measure: Effect of treatment on need of mechanical ventilation at D60 Time: Day 60Description: This outcome corresponds to the duration of patient's mechanical ventilation at D20.
Measure: Effect of treatment on duration of mechanical ventilation at D20 Time: Day 20Description: This outcome corresponds to the duration of patient's mechanical ventilation at D60.
Measure: Effect of treatment on duration of mechanical ventilation at D60 Time: Day 60Description: This outcome evaluates the delay between inclusion and hospitalization at D20.
Measure: Effect of treatment on time to hospitalization at D20 Time: Day 20Description: This outcome evaluates the delay between inclusion and hospitalization at D60.
Measure: Effect of treatment on time to hospitalization at D60 Time: Day 60Description: This outcome evaluates the duration of patient's Hospital stay at D20.
Measure: Effect of treatment on Duration of Hospital stay et D20 Time: Day 20Description: This outcome evaluates the duration of patient's Hospital stay at D60.
Measure: Effect of treatment on Duration of Hospital stay et D60 Time: Day 60Description: This outcome evaluates the duration of symptoms at D20 after treatment.
Measure: Effect of treatment on Duration of symptoms at D20 Time: Day 20Description: This outcome evaluates the duration of symptoms at D60 after treatment.
Measure: Effect of treatment on Duration of symptoms at D60 Time: Day 60Description: This outcome measures the number of participants with treatment-related adverse events as assessed by CTCAE v4.0, at the end of study.
Measure: Incidence of Treatment-Emergent Adverse Events Time: Month 6Description: This outcome evaluates the chest radiological features on Chest HRCT, at 6 months, after treatment.
Measure: Effect of treatment on chest radiological features Time: Month 6Description: This outcome evaluates the Pulmonary function test at 6 month, after treatment.
Measure: Effect of treatment on respiratory capacity Time: Month 6Description: This ouctome eavaluates costs and consequences which will be presented for each stakeholder in a disaggregated way at the end of study.
Measure: Cost consequence analysis Time: Month 6Italy was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidity and mortality associated with the disease. In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease 19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an interventional, non-pharmacological, open, randomized, prospective, non-profit study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early control of disease progression in patients with COVID-19. Contextually, all patients are treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based intervention (accompanied by supplementation with probiotics) in containing the progression of COVID-19 and in preventing the need for hospitalization in intensive care units.
Description: Comparison between the two groups
Measure: Delta in the number of patients requiring orotracheal intubation despite treatment Time: 21 daysDescription: Comparison between the two groups
Measure: Delta of crude mortality Time: 21 daysDescription: Comparison between the two groups
Measure: Delta of length of stay for patients in hospital Time: 90 daysDescription: Comparison between the two groups
Measure: delta in the value of interleukin (IL)-1 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of IL-6 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of IL-10 Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of Tumor Necrosis Factor (TNF)-alpha Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of cluster of differentiation (CD)4+ CD38/ Human Leukocyte Antigen-DR isotype (HLA-DR) Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of CD8+ CD38/ HLA-DR Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of fecal calprotectin Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of lipopolysaccharide (LPS) Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of zonulin Time: 21 daysDescription: Comparison between the two groups
Measure: delta in the value of alpha1-antitrypsin Time: 21 daysIn light of its high morbidity and mortality, COronaVIrus Disease 19 (COVID-19) pandemic spread is considered an unprecedented global health challenge. Given the very limited therapeutic options available against Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic at this time, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an observational, retrospective, non-profit study on the adjuvant use of bacteriotherapy in the early control of disease progression in patients affected by COVID-19 and treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of bacteriotherapy in reducing the clinical impact of acute diarrhea, containing the progression of COVID-19 and preventing the need for hospitalization in intensive care units.
Description: Comparison between the two groups. Acute diarrhea was defined as a stool with increased water content, volume, or frequency that lasts less than 14 days.
Measure: delta of time of disappearance of acute diarrhea Time: 21 daysDescription: Comparison between the two groups
Measure: Delta in the number of patients requiring orotracheal intubation despite treatment Time: 21 daysDescription: Comparison between the two groups
Measure: Delta of crude mortality Time: 21 daysDescription: Comparison between the two groups
Measure: Delta of length of stay for patients in hospital Time: 21 daysThis is a randomized, open-label trial to assess the safety and efficacy of hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a higher risk COVID-19 positive outpatient population.
Description: Patients will be assessed on day 5 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Measure: Time to Resolution of Symptoms relative to baseline (day 1 of trial) Time: Day 5Description: Patients will be assessed on day 14 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Measure: Time to Resolution of Symptoms relative to baseline (day 1 of trial) Time: Day 14Description: Patients will be assessed on day 21 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)
Measure: Time to Resolution of Symptoms relative to baseline (day 1 of trial) Time: Day 21Description: Number of participants hospitalized and/or requiring repeat ER visits related to COVID-19 complications
Measure: Number of participants hospitalized and/or requiring repeat ER visits Time: 21 daysDescription: If hospitalized, number of participants admitted to the ICU, and number of days in the ICU
Measure: ICU Length of Stay Time: Until Discharged up to 30 daysDescription: If placed on ventilator, number of days on a ventilator
Measure: Ventilator Time: Until extubated up to 30 daysDescription: Severity of symptoms evaluated at day 5, day 14, and day 21 scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)
Measure: Severity of symptoms Time: Day 5, Day 14, and Day 21Description: Number of participants with adverse events due to drug regimen
Measure: Number of participants with adverse events due to drug regimen Time: 21 daysDescription: Assess all patients to evaluate for QTc prolongation >500ms
Measure: Number of participants with QTc prolongation >500ms Time: Days 1 thru 5, Day 10, Day 21On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world. To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted. It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Therefore azithromycin (AZM) is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases). The aim of this study is to demonstrate that AZM decreases symptom duration in COVID19 patients and diminishes the viral carriage.
Description: Length of symptom duration (in days) with azithromycin treatment
Measure: Length of symptom duration (in days) with azithromycin treatment Time: up to 2 monthsCurrently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either a combination of azithromycin, hydroxychloroquine and zinc or favipiravir, alongside usual care, can help patients with suspected or proven COVID-19 infection.
Description: Time from randomisation to clinical improvement by two points on a seven-category ordinal scale: Not hospitalised with resumption of normal activities Not hospitalised, but unable to resume normal Hospitalised, not requiring supplemental oxygen Hospitalised, requiring supplemental oxygen Hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation or both Hospitalised, requiring ECMO (Extra-corporal membrane oxygenation), invasive mechanical ventilation or both Death
Measure: Time to improvement by two points on a seven-category ordinal scale Time: Up to 28 days from randomisationDescription: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)
Measure: Clinical status on a seven-category ordinal scale (Day 7) Time: Day 7 from randomisationDescription: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)
Measure: Clinical status on a seven-category ordinal scale (Day 14) Time: Day 14 from randomisationDescription: Survival of patients to end of study
Measure: Overall survival Time: 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS score of patient condition, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS score Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for temperature, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for temperature Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for heartrate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for heartrate Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for respiratory rate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for respiratory rate Time: Up to 28 days from randomisationDescription: Time from randomisation to improvement by two points on the NEWS element score for oxygen saturation, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2
Measure: Time to improvement by two points on the NEWS element score for oxygen saturation. Time: Up to 28 days from randomisationDescription: Frequency of admission of patients to intensive care
Measure: Admission to intensive care Time: Up to 28 days from randomisationDescription: Frequency of requirement to administer mechanical ventilation to patients
Measure: Requirement for mechanical ventilation Time: Up to 28 days from randomisationDescription: Frequency of requirement to administer non-invasive ventilation, continuous positive airways pressure or high-flow oxygen to patients
Measure: Requirement for non-invasive ventilation, continuous positive airways pressure or high-flow oxygen Time: Up to 28 days from randomisationDescription: Frequency of culture-confirmed bacterial or fungal infection in patients
Measure: Incidence of bacterial or fungal infection Time: Up to 28 days from randomisationDescription: Frequency and severity of adverse events in patients not directly attributed by clinicians to COVID-19 infection.
Measure: Incidence of adverse events not directly caused by COVID-19 infection. Time: Up to 28 days from randomisation.Description: Frequency of readmission to inpatient care of patients discharged from hospital.
Measure: Readmission to inpatient care Time: Up to 28 days from randomisationRECOVERY is a randomised trial investigating whether treatment with either Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Convalescent plasma or Tocilizumab prevents death in patients with COVID-19.
Description: For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality.
Measure: All-cause mortality Time: Within 28 days after randomisationDescription: To assess the effects of study treatment on number of days stay in hospital
Measure: Duration of hospital stay Time: Within 28 days and up to 6 months after the main randomisationDescription: To assess the effects of study treatment on number of patients who needed ventilation and the number of days it was required
Measure: Need for (and duration of) ventilation Time: Within 28 days and up to 6 months after the main randomisationDescription: Among patients not on ventilation at baseline, the number of patients with a composite endpoint of death or need for mechanical ventilation or ECMO.
Measure: Composite endpoint of death or need for mechanical ventilation or ECMO Time: Within 28 days and up to 6 months after the main randomisationDescription: To assess the effects of study treatment on number of patients who needed renal replacement therapy
Measure: Need for renal replacement Time: Within 28 days and up to 6 months after the main randomisationDescription: To assess the effects of study treatment on number of patients who develop new major cardiac arrythmias
Measure: Development of new major cardiac arrythmias Time: Within 28 days and up to 6 months after the main randomisationAzithromycin 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 monthsThe host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose < 1 Gy. The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.
Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)
Measure: Oxygen Therapy Status at Day 2 Time: At 2 after RTDescription: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)
Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2 Time: At 2 days after RTDescription: Pa02 / Fi02 > 300 mmHg
Measure: Blood Gas Analysis at Day 2 Time: At 2 days after RTDescription: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)
Measure: Blood Test at Day 2 Time: At 2 days after RTDescription: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)
Measure: Oxygen Therapy Status at Day 5 Time: At 5 after RTDescription: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)
Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5 Time: At 5 days after RTDescription: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)
Measure: Blood Test at Day 5 Time: At 5 days after RTDescription: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)
Measure: Oxygen Therapy Status at Day 7 Time: At 7 after RTDescription: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)
Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7 Time: At 7 days after RTDescription: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)
Measure: Blood Test at Day 7 Time: At 7 days after RTDescription: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)
Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7 Time: At 7 days after RTDescription: Recovery time after RT administration until hospital discharge or death (<48h; 2-7 days; >7 days; clinical worsening or death)
Measure: Recovery time Time: From RT administration until hospital discharge or deathDescription: COVID-19 negativization test
Measure: COVID-19 status Time: At 7 days after RTDescription: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)
Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1 Time: At 1 month after RTDescription: Toxicity was assessed and rated according to the NIH Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and RTOG scales.
Measure: Acute Toxicity Time: 1-3 months after RT