Name (Synonyms) | Correlation | |
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drug156 | COVID-19 exposure Wiki | 0.71 |
drug823 | Telemedicine Wiki | 0.41 |
Name (Synonyms) | Correlation | |
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D009202 | Cardiomyopathies NIH | 0.50 |
D002318 | Cardiovascular Diseases NIH | 0.21 |
D007239 | Infection NIH | 0.06 |
Name (Synonyms) | Correlation |
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There are 2 clinical trials
COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate potential therapeutics for the treatment of hospitalized COVID-19. We hypothesis that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid declines in viral load in throat swabs. This viral attenuation should be associated with improved patient outcomes. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19. The study is funded and leaded by The Ministry of Health, Vietnam.
Description: Viral presence will be determined using RT-PCR to detect SARS-CoV-19 RNA. Throat swabs for viral RNA will be taken daily while in hospital until there have at least 2 consecutive negative results . Virus will be defined as cleared when the patient has had ≥2 consecutive negative PCR tests. The time to viral clearance will be defined as the time following randomization to the first of the negative throat swabs.
Measure: Viral clearance time Time: Up to 56 days post randomizationDescription: The time since randomization to discharge between study groups
Measure: Lengh of hospital stay Time: Up to 56 days post randomizationDescription: The number of ventilator free days over the first 28 days of treatment
Measure: Ventilator free days Time: first 28 daysDescription: The number of oxygene free days over the first 28 days of treatment
Measure: Oxygene free days Time: first 28 daysDescription: The time to (all-cause) death following over the first 7, 10, 14, 28 and 56 days since randomization
Measure: Time to death Time: first 7, 10, 14, 28 and 56 days since randomizationDescription: The rates of serious adverse events, rates of grade 3 or 4 adverse events
Measure: Adverse events Time: Over the first 28 days (due to the prolonged half-life of Chloroquine)Description: Time since randomization to the first viral PCR negative from rectal swab
Measure: Time to viral PCR negative from rectal swab Time: During the first 56 days post randomizationDescription: Time since randomization to the first defervescence day
Measure: fever clearance time Time: Up to 56 days post randomizationDescription: WHO Ordinal outcome scale for COVID-19
Measure: Ordinal outcome scale Time: Up to 56 days post randomizationDescription: Development of ARDS defined by the Kigali criteria
Measure: Development of ARDS Time: Up to 56 days post randomizationThe aim of the study is to evaluate whether the therapy with chloroquine phosphate (CQ, in combination with telemedical approach) in addition to standard care is effective and safe in reducing composite endpoint of COVID-19-related hospitalization or all cause death, in ambulatory patients with SARS-SoV-2 infection at particular risk of serious complications due to advanced age and/or comorbid conditions (in comparison with subjects not treated with CQ but receiving standard care and supervised telemedically).
Description: Composite endpoint of COVID-19-related hospitalization or all-cause death
Measure: COVID-19-related hospitalization or all-cause death Time: 15 daysDescription: Decrease in self-reported symptoms of novel coronavirus infection. Non-dichotomous symptoms (e.g. syncope is dichotomous - yes or no) such as dyspnoea will be self-evaluated by patients using the 0-3 scale with the severity increasing with the punctation (0-no symptoms, 1-mild symptoms, 2-moderate symptoms, 3-severe symptoms).
Measure: Decrease in COVID-19 symptoms Time: 15 days and 42 daysDescription: Based on X-ray, microbiology and laboratory results
Measure: Development of pneumonia Time: 42 daysDescription: Acute respiratory distress syndrome, bacterial infection, shock, sepsis, etc
Measure: Development of coronavirus infection-related complications Time: 42 days