Name (Synonyms) | Correlation | |
---|---|---|
drug275 | Association of diltiazem and niclosamide Wiki | 0.71 |
drug1430 | Inspiratory training device Wiki | 0.71 |
drug1046 | Expiratory training device Wiki | 0.71 |
drug3469 | standard concomitant therapy Wiki | 0.71 |
drug8 | 0.9% Sodium-chloride Wiki | 0.71 |
drug1238 | Heparin Wiki | 0.41 |
drug1087 | Favipiravir Wiki | 0.16 |
drug1284 | Hydroxychloroquine Wiki | 0.07 |
Name (Synonyms) | Correlation | |
---|---|---|
D012120 | Respiration Disorders NIH | 0.18 |
D012140 | Respiratory Tract Diseases NIH | 0.15 |
D055370 | Lung Injury NIH | 0.14 |
D014947 | Wounds and Injuries NIH | 0.14 |
D055371 | Acute Lung Injury NIH | 0.07 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.06 |
D003141 | Communicable Diseases NIH | 0.06 |
D007239 | Infection NIH | 0.04 |
Name (Synonyms) | Correlation |
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There are 2 clinical trials
No optimal antiviral intervention has been yet validated to treat COVID-19 disease. Comorbidities, such as older age, obesity, diabetes, history of cardiovascular diseases are associated with poor prognosis. This study aims to evaluate the efficacy of two experimental antiviral treatments, compared to standard of care (SOC), to prevent clinical worsening, hospitalization or death at day 14 in adults with documented SARS-CoV-2 infection, asymptomatic or with symptoms lasting less than 8 days, and associated comorbidities without any severity criteria of the disease at inclusion. Participants will be randomized to receive SOC alone or SOC + hydroxychloroquine 200 mg three times a day during 10 days or SOC + association of niclosamide 2 g at J1 then 500 mg two times a day with diltiazem 60 mg three times a day during 10 days. Efficacy and tolerance of each treatments will be compared across the three treatment groups during the 28 days of follow-up.
Description: Composite criteria
Measure: death Time: At day 14Description: clinical worsening defined by at least one of the NEWS score item > 2 (temperature >39,1°C or<35°C, cardiac rate >111 or ≤40 bpm, respiratory rate > 21 or ≤8 cycles par minute, SaO2 ≤ 93% room air (if its measure is available),need of oxygen
Measure: clinical worsening (composite criteria) Time: At day 14Description: clinical state as reflected by NEWS scoring, the clinical state of the patient regarding respiratory state as defined by the NEWS scoring system
Measure: National Early Warning Score (NEWS) Time: at day 3, day 8, day 14 day 28Description: Number of patients death
Measure: Mortality Time: at day 14 and at day 28Randomized open-label multicenter parallel-group study of efficacy and safety of TL-FVP-t vs. standard of care therapy in patients with mild to moderate coronavirus disease (SARS-CoV-2/COVID-19)
Description: To determine the effect of TL-FVP-t vs. SOC on time to clinical improvement. The clinical improvement is defined as reduction on at least 1 score of patient clinical status according to WHO 8-category Ordinal Scale for Clinical Improvement compared to screening
Measure: Time to clinical improvement Time: through Day 28Description: To determine the effect of TL-FVP-t vs. SOC on time to viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling
Measure: Time to viral clearance Time: through Day 28Description: To determine the effect of TL-FVP-t vs. SOC on proportion of subjects (%) with clinical improvement according to WHO 8-category Ordinal Scale for Clinical Improvement
Measure: Rate of clinical improvement at separate time points Time: Day 7Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with viral clearance of SARS-CoV-2 virus as measured by PCR in oropharyngeal sampling at separate time points
Measure: Rate of viral clearance at separate time points Time: Days 5 and 7Description: To determine the effect of TL-FVP-t vs. SOC on time to body temperature normalization determined as body temperature < 37°C without antipyretics for at least 48 hours.
Measure: Time to body temperature normalization Time: through Day 28Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with resolution of lung changes on CT
Measure: Rate of resolution of lung changes on CT Time: Day 14Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with ADR and serious ADR
Measure: Rate of adverse drug reactions (ADR) and serious ADR Time: through Day 28Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) with severe ADR
Measure: Rate of severe ADR Time: through Day 28Description: To determine the effect of TL-FVP-t vs. SOC on a proportion of subjects (%) discontinued therapy due ADR
Measure: Rate therapy termination due to ADR Time: through Day 28