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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1520 | Hydroxychloroquine Wiki | 0.36 |
| drug3906 | hydroxychloroquine Wiki | 0.25 |
| drug1895 | Low molecular weight heparin Wiki | 0.23 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug925 | Corticosteroid Wiki | 0.23 |
| drug3142 | SivoMixx (200 billion) Wiki | 0.23 |
| drug3408 | Telmisartan Wiki | 0.19 |
| drug2491 | Physical Therapy Wiki | 0.16 |
| drug1854 | Lopinavir / Ritonavir Pill Wiki | 0.16 |
| drug2023 | Mesenchymal Stromal Stem Cells - KI-MSC-PL-205 Wiki | 0.16 |
| drug1634 | Immunoglobulin Wiki | 0.16 |
| drug2496 | Physiology Wiki | 0.16 |
| drug429 | BVA-100 Wiki | 0.16 |
| drug3755 | Zinc Sulfate Wiki | 0.16 |
| drug1270 | F-652 Wiki | 0.16 |
| drug2028 | Mesenchymal stromal cell-based therapy Wiki | 0.16 |
| drug3617 | VIB7734 Wiki | 0.16 |
| drug2815 | Razuprotafib Subcutaneous Solution Wiki | 0.16 |
| drug4166 | ventilatory support with oxygen therapy Wiki | 0.16 |
| drug1489 | High-intensity training Wiki | 0.16 |
| drug1852 | Lopinavir Wiki | 0.16 |
| drug2910 | Ritonavir/lopinavir Wiki | 0.16 |
| drug4081 | regular care Wiki | 0.16 |
| drug3576 | Umbilical Cord Mesenchymal Stem Cells Wiki | 0.16 |
| drug3938 | lanadelumab Wiki | 0.16 |
| drug3845 | consultation Wiki | 0.16 |
| drug4064 | quality of life questionnaires Wiki | 0.16 |
| drug1860 | Lopinavir 200Mg/Ritonavir 50Mg Tab Wiki | 0.16 |
| drug3830 | chlorine dioxide 3000 ppm Wiki | 0.16 |
| drug2423 | Paraclinical examination Wiki | 0.16 |
| drug1250 | Experts consensus Wiki | 0.16 |
| drug1111 | Dutasteride Wiki | 0.16 |
| drug2537 | Placebo capsules Wiki | 0.16 |
| drug3493 | Tocilizumab Injection [Actemra] Wiki | 0.16 |
| drug1248 | Experimental drug Wiki | 0.16 |
| drug2534 | Placebo Subcutaneous Solution Wiki | 0.16 |
| drug2364 | Oxygen supply Wiki | 0.16 |
| drug2080 | Moderate-intensity continuous training Wiki | 0.16 |
| drug550 | Brexanolone Wiki | 0.16 |
| drug3080 | Semi-directive interview Wiki | 0.16 |
| drug2687 | Proxalutamide Wiki | 0.16 |
| drug2019 | Mesenchymal Stem Cell Wiki | 0.16 |
| drug2399 | PLN-74809 Wiki | 0.16 |
| drug4086 | retrospective metagenomics on clinical samples collected during hospitalization Wiki | 0.16 |
| drug2790 | RTB101 Wiki | 0.16 |
| drug1902 | Low-dose radiotherapy Wiki | 0.16 |
| drug3673 | Vitamin B12 Wiki | 0.16 |
| drug400 | BI 706321 Wiki | 0.16 |
| drug2365 | Oxygen-ozone therapy, probiotic supplementation and Standard of care Wiki | 0.16 |
| drug2362 | Oxygen Therapy Wiki | 0.16 |
| drug1342 | Folic Acid Wiki | 0.16 |
| drug1213 | Equipment with smartwatch throughout hospital stay on the general ward Wiki | 0.16 |
| drug1014 | Defibrotide Wiki | 0.16 |
| drug2535 | Placebo Tablet Wiki | 0.16 |
| drug926 | Corticosteroid injection Wiki | 0.16 |
| drug3572 | Ultra-Low-dose radiotherapy Wiki | 0.16 |
| drug3751 | Zinc Citrate Wiki | 0.16 |
| drug2908 | Ritonavir Wiki | 0.16 |
| drug1023 | Descartes 30 Wiki | 0.16 |
| drug2504 | Piperacillin/tazobactam Wiki | 0.16 |
| drug2166 | Nebulised heparin Wiki | 0.16 |
| drug703 | CYP-001 Wiki | 0.16 |
| drug1093 | Doxycycline Wiki | 0.15 |
| drug1538 | Hydroxychloroquine Sulfate Wiki | 0.14 |
| drug2351 | Oseltamivir Wiki | 0.12 |
| drug779 | Chloroquine Sulfate Wiki | 0.12 |
| drug1863 | Lopinavir-Ritonavir Wiki | 0.12 |
| drug3749 | Zinc Wiki | 0.12 |
| drug3497 | Tofacitinib 10 mg Wiki | 0.12 |
| drug802 | Clinical Examination Wiki | 0.12 |
| drug1582 | Hypothermia Wiki | 0.12 |
| drug2176 | Neuromuscular Blocking Agents Wiki | 0.12 |
| drug1745 | Ivermectin Wiki | 0.11 |
| drug3674 | Vitamin C Wiki | 0.09 |
| drug2895 | Rifampin Wiki | 0.08 |
| drug3485 | Tocilizumab Wiki | 0.08 |
| drug790 | Cholecalciferol Wiki | 0.08 |
| drug1434 | HCQ Wiki | 0.08 |
| drug304 | Ascorbic Acid Wiki | 0.08 |
| drug464 | Best Practice Wiki | 0.07 |
| drug3046 | Sarilumab Wiki | 0.07 |
| drug3231 | Standard of care Wiki | 0.07 |
| drug2505 | Placebo Wiki | 0.07 |
| drug3678 | Vitamin D3 Wiki | 0.07 |
| drug3257 | Standard treatment Wiki | 0.07 |
| drug776 | Chloroquine Wiki | 0.06 |
| drug2557 | Placebo oral tablet Wiki | 0.06 |
| drug3676 | Vitamin D Wiki | 0.06 |
| drug1872 | Lopinavir/ritonavir Wiki | 0.05 |
| drug2194 | Nitazoxanide Wiki | 0.05 |
| drug2572 | Placebos Wiki | 0.04 |
| drug908 | Convalescent plasma Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D055371 | Acute Lung Injury NIH | 0.28 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.25 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000071074 | Neonatal Sepsis NIH | 0.16 |
| D011470 | Prostatic Hyperplasia NIH | 0.16 |
| D006965 | Hyperplasia NIH | 0.16 |
| D011645 | Puerperal Infection NIH | 0.16 |
| D066087 | Perinatal Death NIH | 0.16 |
| D063130 | Maternal Death NIH | 0.16 |
| D000505 | Alopecia NIH | 0.12 |
| D003967 | Diarrhea NIH | 0.12 |
| D014115 | Toxemia NIH | 0.12 |
| D007035 | Hypothermia NIH | 0.12 |
| D013577 | Syndrome NIH | 0.10 |
| D011251 | Pregnancy Complications, Infectious NIH | 0.09 |
| D003643 | Death, NIH | 0.08 |
| D018805 | Sepsis NIH | 0.07 |
| D055370 | Lung Injury NIH | 0.06 |
| D011665 | Pulmonary Valve Insufficiency NIH | 0.06 |
| D014947 | Wounds and Injuries NIH | 0.06 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
| D011024 | Pneumonia, Viral NIH | 0.06 |
| D018352 | Coronavirus Infections NIH | 0.06 |
| D011014 | Pneumonia NIH | 0.05 |
| D003141 | Communicable Diseases NIH | 0.05 |
| D007239 | Infection NIH | 0.05 |
| D012598 | Scoliosi NIH | 0.05 |
| D009103 | Multiple Sclerosis NIH | 0.05 |
| D018450 | Disease Progression NIH | 0.04 |
| D016638 | Critical Illness NIH | 0.02 |
| D014777 | Virus Diseases NIH | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0003811 | Neonatal death HPO | 0.16 |
| HP:0008711 | Benign prostatic hyperplasia HPO | 0.16 |
| HP:0002014 | Diarrhea HPO | 0.16 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0040187 | Neonatal sepsis HPO | 0.16 |
| HP:0002293 | Alopecia of scalp HPO | 0.12 |
| HP:0100806 | Sepsis HPO | 0.07 |
| HP:0010444 | Pulmonary insufficiency HPO | 0.06 |
| HP:0002090 | Pneumonia HPO | 0.06 |
Navigate: Correlations HPO
There are 37 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.
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.
Description: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group.
Measure: Maternal: Incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery in intervention vs. placebo group. Time: within 6 weeks (42 days)Description: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group
Measure: Neonatal: Incidence of intrapartum/neonatal death or sepsis within 4 weeks (28 days) post-delivery in intervention vs. placebo group Time: 4 weeks (28 days) post-deliveryDescription: Fever (>100.4°F/38°C) in addition to one or more of the following: fetal tachycardia ≥160 bpm, maternal tachycardia >100 bpm, tender uterus between contractions, or purulent/foul smelling discharge from uterus prior to delivery.
Measure: Incidence of chorioamnionitis Time: prior to deliveryDescription: Fever (>100.4°F/38°C) in addition to one or more of maternal tachycardia >100 bpm, tender uterine fundus, or purulent/foul smelling discharge from uterus after delivery.
Measure: Incidence of endometritis Time: within 42 days post-deliveryDescription: Wound infection (Purulent infection of a perineal or Cesarean wound with or without fever. In the absence of purulence, requires presence of fever >100.4°F/38°C and at least one of the following signs of local infection: pain or tenderness, swelling, heat, or redness around the incision/laceration); Abdominopelvic abscess (Evidence of pus in the abdomen or pelvis noted during open surgery, interventional aspiration or imaging); Pneumonia (Fever >100.4°F/38°C and clinical symptoms suggestive of lung infection including cough and/or tachypnea >24 breaths/min or radiological confirmation); Pyelonephritis (Fever >100.4°F/38°C and one or more of the following: urinalysis/dip suggestive of infection, costovertebral angle tenderness, or confirmatory urine culture); Mastitis/breast abscess or infection (Fever >100.4°F/38°C and one or more of the following: breast pain, swelling, warmth, redness, or purulent drainage).
Measure: Incidence of other infections Time: within 42 days post-deliveryDescription: Use of subsequent maternal antibiotic therapy after randomization to 42 days postpartum for any reason.
Measure: Incidence of use of subsequent maternal antibiotic therapy Time: after randomization to 42 days post-deliveryDescription: Time from drug administration until initial discharge after delivery (time may vary by site).
Measure: Maternal initial hospital length of stay Time: within 42 days post-deliveryDescription: Maternal readmissions within 42 days of delivery
Measure: Incidence of maternal readmissions Time: within 42 days post-deliveryDescription: Maternal admission to special care units
Measure: Incidence of maternal admission to special care units Time: within 42 days post-deliveryDescription: Maternal unscheduled visit for care
Measure: Incidence of maternal unscheduled visit for care Time: within 42 days post-deliveryDescription: Maternal GI symptoms including nausea, vomiting, and diarrhea and other reported side effects.
Measure: Incidence of maternal GI symptoms Time: within 42 days post-deliveryDescription: Maternal death due to sepsis using the Global Network algorithm for cause of death
Measure: Incidence of maternal death due to sepsis Time: within 42 days post-deliveryDescription: Incidence of other neonatal infections.
Measure: Incidence of other neonatal infections (e.g. eye infection, skin infection) Time: within 42 days post-deliveryDescription: Neonatal initial hospital length of stay, defined as time of delivery until initial discharge (time may vary by site).
Measure: Neonatal initial hospital length of stay Time: within 28 days of deliveryDescription: Neonatal readmissions within 42 days of delivery
Measure: Incidence of neonatal readmissions Time: within 42 days of deliveryDescription: Neonatal admission to special care units
Measure: Incidence of neonatal admission to special care units Time: within 28 days of deliveryDescription: Neonatal unscheduled visit for care
Measure: Incidence of neonatal unscheduled visit for care Time: within 42 days post-deliveryDescription: Neonatal death due to sepsis using the Global Network algorithm for causes of death
Measure: Incidence of neonatal death due to sepsis Time: within 28 days of deliveryDescription: Pyloric stenosis within 42 days of delivery, defined as clinical suspicion based on severe vomiting leading to death, surgical intervention (pyloromyotomy) as verified from medical records, or radiological confirmation.
Measure: Incidence of pyloric stenosis within 42 days of delivery Time: within 42 days of deliveryThis 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 daysThis study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19.
Description: Per 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: COVID Ordinal Outcomes Scale at 14 days Time: Assessed once on day 14 after enrollment (enrollment is day 0)Description: Calculated as a worst-rank ordinal (death is counted as -1 days).
Measure: Hospital-free days at 28 days (number of days patient not in hospital) Time: Admission (day 1) to 28 days after admission (day 28)Description: Calculated as a worst-rank ordinal (death is counted as -1 days).
Measure: Ventilator-free days at 28 days (number of days patient not on a ventilator) Time: Admission (day 1) to 28 days after admission (day 28)Description: Calculated as a worst-rank ordinal (death is counted as -1 days).
Measure: ICU-free days at 28 days (number of days patient not in an ICU) Time: Admission (day 1) to 28 days after admission (day 28)COVID-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 daysQ-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.
Description: Days
Measure: Proportion of virologically cured (PCR-negative status) as assessed on day six Time: Day 6Description: Days
Measure: virologic cure on other study days Time: Day14 and Day 21Description: Days
Measure: virologic semiquantitative analysis of changing viral load Time: Day 1 to Day 21Description: Days
Measure: proportion of initially symtomatic subjects with disappearance of clinical symptoms Time: Day14 and Day 21Description: Days
Measure: proportion of initially asymtomatic subjects with appearance of new clinical symptoms Time: Day14 and Day 21Description: grades
Measure: proportions of subjects with potentially medication- related adverse events Time: 7 dayThis 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 monthsLow 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.
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 radiotherapyDescription: 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 radiotherapyRECOVERY 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: Among patients not on mechanical 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 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: 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 RTCOVID-19 is a global pandemic. So far encouraging results have been shown in different parts of the world with the utilisation of hydroxycloroquine, zinc, and azithromycin, and early studies into some of these, plus some with Vitamin C, have also proven beneficial. Vitamin D levels have also been shown to be an important indicator to the severity of symptoms in COVID-19 patients.
Description: Composite measure: Change in severity and duration of symptoms
Measure: Symptoms Time: once daily for 15 days since enrollment/baseline at admission to hospitalDescription: total number of days in hospital since admission
Measure: Length of hospital stay Time: at 15 and 45 days since admission/ enrolmentDescription: need for invasive mechanical ventilation or mortality within 15 days from enrolment
Measure: invasive mechanical ventilation or mortality Time: any time within 15 days from enrolmentDescription: Death
Measure: Mortality Time: 15 and 45 days since enrolmentDescription: need for and number of days of invasive mechanical ventilation, in case of no need for mechanical ventilation: days=0
Measure: mechanical ventilation Time: at 15 and 45 days since enrolmentDescription: need for and number of days for humidified high-flow oxygen
Measure: oxygen Time: 15 and 45 days since enrolmentDescription: admission to ICU (intensive care unit)
Measure: ICU Time: 15 and 45 days since enrolmentDescription: days in hospital
Measure: days in hospital Time: 15 and 45 days since enrolmentDescription: days in ICU
Measure: days in ICU Time: 15 and 45 days since enrolmentDescription: need for and days of renal replacement therapy
Measure: renal replacement therapy Time: 15 and 45 days since enrolmentDescription: need for and days of Extracorporeal support
Measure: Extracorporeal support Time: 15 and 45 days since enrolmentAs the world faces COVID-19, the search for effective treatments against the disease and its complications has turned its gaze to drugs that are classically used in other infectious diseases. Some drugs are being examined for the recent evidence on its effects on viral replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase serum concentration of 25-hydroxyvitamin D.
Description: Test for virus at day 1 and 14 from beginning of trial drug started
Measure: Viral clearance Time: 14 daysDescription: The duration of symptoms in days
Measure: Symptoms duration Time: 14 daysDescription: oxygen saturation
Measure: SpO2 Time: 14 daysDescription: Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio
Measure: SpO2/FiO2 Time: 14 daysThis study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection
Description: Percentage of subjects hospitalized due to COVID-19
Measure: COVID-19 hospitalization Time: 30 daysDescription: COVID Ordinal Scale defined as: Death Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) Hospitalized on non-invasive ventilation or high flow nasal cannula Hospitalized on supplemental oxygen Hospitalized not on supplemental oxygen Not hospitalized with limitation in activity (continued symptoms) Not hospitalized without limitation in activity (no symptoms)
Measure: COVID-19 Ordinal Outcomes Scale Time: 30 daysDescription: Symptoms severity of COVID-19 using Brescia-COVID Respiratory Severity Scale (BCRSS)/Algorithm
Measure: Symptoms severity of COVID-19 Time: 30 daysNovel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%. The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection. Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding. Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.
Description: Assessing whether the patients still have dyspnea, one of cardinal symptoms of Covid-19, assessed from the respiratory rate
Measure: Clinical improvement: Presence of dyspnea Time: 15 daysDescription: Assessing whether the patients still have productive cough, one of cardinal symptoms of Covid-19, assessed from lung auscultation
Measure: Clinical improvement: presence of sputum Time: 15 daysDescription: Assessing the presence of fever from measurement of body temperature checking, assessed on daily basis
Measure: Clinical improvement: fever Time: 15 daysDescription: Assessing whether the patients still require ventilation, one of cardinal symptoms of ARDS in Covid-19, assessed from patients' ability during ventilation weaning phase
Measure: Clinical improvement: ventilation status Time: 15 daysDescription: Assessing the patients' blood pressure on daily basis
Measure: Clinical improvement: blood pressure Time: 15 daysDescription: Assessing the patients' heart rate on daily basis
Measure: Clinical improvement: heart rate Time: 15 daysDescription: Assessing the patients' respiratory rate on daily basis
Measure: Clinical improvement: respiratory rate Time: 15 daysDescription: Assessing the patients' oxygen saturation on daily basis
Measure: Clinical improvement: oxygen saturation Time: 15 daysDescription: Assessing the changes in total leukocyte upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from leukocyte level Time: 15 daysDescription: Assessing the changes in lymphocytes level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from lymphocytes level Time: 15 daysDescription: Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood pH Time: 15 daysDescription: Assessing the changes in blood pH level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood level of CO2 Time: 15 daysDescription: Assessing the changes in blood base excess level upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood base excess level Time: 15 daysDescription: Assessing the changes in blood oxygen partial pressure upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood oxygen partial pressure Time: 15 daysDescription: Assessing the changes in blood level of HCO3 upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood level of HCO3 Time: 15 daysDescription: Assessing the changes in blood level of O2 saturation upon MSCs administration, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from blood level of O2 saturation Time: 15 daysDescription: Assessing the changes in level of CRP, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from level of CRP Time: 15 daysDescription: Assessing the changes in laboratory parameter, consist of SGOT/SGPT (AST/ALT) level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from level of SGOT/SGPT (AST/ALT) Time: 15 daysDescription: Assessing the changes in laboratory parameter, consist of ureum/creatinine level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of ureum/creatinine level Time: 15 daysDescription: Assessing the changes in laboratory parameter, consist of eGFR, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of eGFR Time: 15 daysDescription: Assessing the changes in level of sodium, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of sodium Time: 15 daysDescription: Assessing the changes in level of potassium, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of potassium Time: 15 daysDescription: Assessing the changes in level of chloride, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from the level of chloride Time: 15 daysDescription: Assessing the changes in procalcitonin level to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Changes in procalcitonin level Time: 15 daysDescription: Assessing the changes in albumin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from albumin level Time: 15 daysDescription: Assessing the changes in total bilirubin level, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: General laboratory outcome from total bilirubin level Time: 15 daysDescription: Assessing the changes in D-Dimer to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Changes in D-Dimer level Time: 15 daysDescription: Assessing the changes in fibrinogen to assess the anti-inflammatory properties of MSCs, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Changes in fibrinogen level Time: 15 daysDescription: Assessing the changes in troponin level to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Cardiac changes from troponin level Time: 15 daysDescription: Assessing the changes in NT proBNP to assess the anti-inflammatory properties of MSCs and their effect in cardiac remodelling, assessed prior to and 1st day after implantation, then once every 3 days post implantation
Measure: Cardiac changes from NT proBNP level Time: 15 daysDescription: Assessing the changes in leukemia inhibiting factor (LIF) to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in Leukemia Inhibiting Factor Time: 7 daysDescription: Assessing the changes in level of IL-6 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of IL-6 Time: 7 daysDescription: Assessing the changes in level of IL-10 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of IL-10 Time: 7 daysDescription: Assessing the changes in vascular endothelial growth factor (VEGF) to assess the effect of growth factors in the MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of vascular endothelial growth factor (VEGF) Time: 7 daysDescription: Assessing the changes in level of ferritin to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of ferritin Time: 7 daysDescription: Assessing the changes in level of CXCR3 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CXCR3 Time: 7 daysDescription: Assessing the changes in level of CD4 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CD4 Time: 7 daysDescription: Assessing the changes in level of CD8 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CD8 Time: 7 daysDescription: Assessing the changes in CD56 to assess the anti-inflammatory properties of MSCs, assessed prior to implantation and on the 7th day post-implantation
Measure: Changes in level of CD56 Time: 7 daysDescription: Assessing the changes in radiology examination (Chest X-Ray/CT Scan) for any increased in lung infiltration or ground glass opacity, assessed prior to implantation and once every 3 days post-implantation
Measure: Radiologic Improvement from Chest X-Ray/CT Scan Time: 15 daysThis research is designed as an open-label,non-comparative prospective trial.
Description: To measure the duration of viral shedding in respiratory secretions of patients with moderate or severe COVID-19 infection treated with the combination of Hydroxychloroquine and azithromycin. Measured via negative PCR test from nasopharyngeal swabs or oropharyngeal swabs in nonventilator dependent patient or tracheal secretions in ventilator dependent patient on days 3, 6, and 14.
Measure: Duration of viral shedding Time: 1 monthDescription: Evaluate the case fatality rate in hospitalized patients with moderate and severe COVID-19 infection.
Measure: Evaluation of Fatality Rate Time: 6 monthsDescription: Evaluation of clinical response in hospitalized patients with moderate and severe COVID-19 infection.
Measure: Evaluation of Clinical Response Time: 6 monthsDescription: Evaluate the length of hospital stay in hospitalized patients with moderate and severe COVID-19 infection.
Measure: Evaluation of Length of Hospital Stay Time: 6 monthsThis study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.
Description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores Time: 6 monthsDescription: Time to non-infectivity as measured by PCR testing
Measure: Efficacy of Treatment by Time to Non-Infectivity Time: 10 daysDescription: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores Time: 6 monthsDescription: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measure: Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores. Time: 6 monthsDescription: Changes in blood parameters measured in a Complete Blood Count (CBC).
Measure: Safety of Dual Therapy as Measured by Complete Blood Count Time: 6 monthsDescription: Changes in blood parameters measured in a Complete Metabolic Panel.
Measure: Safety of Quadruple Therapy as Measured by Complete Blood Count Time: 6 monthsDescription: Changes in serum albumin levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel -Albumin Time: 6 monthsDescription: Changes in serum albumin levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin Time: 6 monthsDescription: Changes in serum albumin/globulin ratio
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio Time: 6 monthsDescription: Changes in serum albumin/globulin ratio
Measure: Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio Time: 6 monthsDescription: Changes in serum alkaline phosphatase levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase Time: 6 monthsDescription: Changes in serum alkaline phosphatase levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase Time: 6 monthsDescription: Changes in serum AST levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - AST Time: 6 monthsDescription: Changes in serum AST levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - AST Time: 6 monthsDescription: Changes in serum ALT levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT Time: 6 monthsDescription: Changes in serum ALT levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel ALT Time: 6 monthsDescription: Changes in serum BUN/Creatinine Ratio
Measure: Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio Time: 6 monthsDescription: Changes in serum BUN/Creatinine Ratio
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio Time: 6 monthsDescription: Changes in serum Blood Urea Nitrogen levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN Time: 6 monthsDescription: Changes in serum Blood Urea Nitrogen levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - BUN Time: 6 monthsDescription: Changes in serum calcium levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Calcium Time: 6 monthsDescription: Changes in serum calcium levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium Time: 6 monthsDescription: Changes in serum carbon dioxide levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide Time: 6 monthsDescription: Changes in serum carbon dioxide levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide Time: 6 monthsDescription: Changes in serum chloride levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Chloride Time: 6 monthsDescription: Changes in serum chloride levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride Time: 6 monthsDescription: Changes in serum creatinine levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine Time: 6 monthsDescription: Changes in serum creatinine levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine Time: 6 monthsDescription: Changes in serum globulin levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Globulin Time: 6 monthsDescription: Changes in serum globulin levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin Time: 6 monthsDescription: Changes in blood glucose levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose Time: 6 monthsDescription: Changes in blood glucose levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Glucose Time: 6 monthsDescription: Changes in blood potassium levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Potassium Time: 6 monthsDescription: Changes in blood potassium levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium Time: 6 monthsDescription: Changes in serum total bilirubin levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin Time: 6 monthsDescription: Changes in serum total bilirubin levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin Time: 6 monthsDescription: Changes in serum total protein levels
Measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein Time: 6 monthsDescription: Changes in serum total protein levels
Measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein Time: 6 monthsDescription: Presence or absence of treatment related serious adverse events Grade III or higher
Measure: Safety of Dual Therapy as Measured by Treatment Related SAE Time: 6 monthsDescription: Presence or absence of treatment related serious adverse events Grade III or higher
Measure: Safety of Quadruple Therapy as Measured by Treatment Related SAE Time: 6 monthsEvaluation of the efficacy and safety of Treatments for Patients Hospitalized for COVID-19 Infection without signs of acute respiratory failure, in Tunisia Multicentric Randomized Comparative Study
Description: The healing criteria are defined clinically as: disappearance of clinical signs of acute respiratory infection absence of fever
Measure: Evaluate the rate of patients cured at the end of the study. Time: 2 monthsDescription: A patient will be defined as pauci-symptomatic if presence: Light dry cough Discomfort, More or less : Headache, Muscle pain
Measure: Evaluate the rate of patients are pauci-symptomatic at the end of the study. Time: 2 monthsDescription: Patients require transfer to intensive care with the appearance of: Acute respiratory failure: PaO2 <60 mmHg in AA gold Signs of circulatory insufficiency: mottling, tachycardia, systolic BP ≤90mmHg or having dropped by 40 mmHg compared to base BP or Confusion or alteration of the state of consciousness
Measure: Evaluate the rate of patients with worsening clinical signs Time: 2 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports