There is one clinical trial.
This study aims to investigate the potential antiviral efficacy and safety of a novel formulation of Niclosamide; a well-known antihelmintic agent, together with an established COVID-19 treatment regimen in patients. The aim of this study is to evaluate the safety and efficacy profile of niclosamide from the test product (Niclosamide 200 mg/10 mL Suspension) in patients treated for the novel coronavirus infectious disease (COVID-19) in a placebo controlled phase III trial. Both treatment groups will receive an established treatment regimen against COVID-19 together with either niclosamide or placebo. The efficacy and safety of the molecule is well-known and the properties of novel formulation is well-established. The promising in vitro results of niclosamide as an antiviral compound is well documented and make it an ideal candidate as a therapy against SARS-CoV 2 infection. A good safety profile is expected with solid antiviral activity.
Description: The physician will check for the following symptoms: Fever: axillary temperature ≤36.6°C or oral temperature ≤37.2 °C; Respiratory rate: ≤24/minute on room air; Oxygen saturation: >94% on room air; Cough: mild or absent on a patient reported scale of severe, moderate, mild, absent.)Measure: Physician's judgment on clinical recovery from the time of admission Time: Day 1 to day 19
Description: (National Early Warning Score 2) to 0 to 3 (Improvement in fever, respiratory rate, oxygen saturation,alleviation of cough scores to 3 points to 0 in 72 hours)Measure: Clinical improvement in NEWS2 Time: 3 days from admission
Description: An elevated D-dimer,ferritin, thrombocyte, PT, aPTT, troponine and fibrinogen were associated with a poor outcome in COVID19. These parameters will be checked on day 1 and day 3.Measure: Improvement in serum biomarkers Time: Day 1 to day 3
Description: Requirement for indotracheal intubation is a key outcome for unsuccesful treatmentMeasure: Requirement for indotracheal intubation Time: Day 1 to day 19
Description: Occurrence of Macrophage Activation Syndrome(MAS) will alert the physician that the patients condition is worsening.Measure: Occurrence of Macrophage Activation Syndrome(MAS) Time: Day 1 to day 19
Description: Occurrence of Coagulopathy will alert the physician that the patients condition is worsening.Measure: Occurrence of Coagulopathy Time: Day 1 to day 19
Description: The assessment of safety will be based on CTCAE v4.0Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time: Day 1 to day 19
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