Name (Synonyms) | Correlation | |
---|---|---|
drug497 | Human Biological samples Wiki | 0.71 |
drug1376 | plasma therapy using convalescent plasma with antibody against SARS-CoV-2 Wiki | 0.71 |
drug431 | Favipiravir Wiki | 0.22 |
drug505 | Hydroxychloroquine Wiki | 0.08 |
Name (Synonyms) | Correlation | |
---|---|---|
D045169 | Severe Acute Respiratory Syndrome NIH | 0.08 |
D003141 | Communicable Diseases NIH | 0.07 |
D018352 | Coronavirus Infections NIH | 0.07 |
D007239 | Infection NIH | 0.05 |
Name (Synonyms) | Correlation |
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There are 2 clinical trials
Plasma therapy using convalescent plasma has been shown to be effective in severe acute respiratory syndrome, Ebola virus infection and in H1N1 influenza. More recently there has been a report of the use of convalescent plasma in the treatment of 5 ventilated COVID-19 patients with the suggestion of expedited recovery as the patients improved 1 week after the transfusion. However, this was not a clinical trial and the patients were on other antiviral medication.; therefore, there is a need to undertake such a trial to see if deploying plasma with SARS-CoV-2 neutralizing antibody has utility in managing patients infected with COVID-19 in respiratory distress. The objective of this pilot study is to compare plasma therapy using convalescent plasma with antibody against SARS-CoV-2 to usual supportive therapy in COVID-19 patients with pneumonia and hypoxia, and to determine if the clinical course is improved. The difference between groups will allow an effect size to be determined for a definitive clinical trial.
Description: Could the plasma therapy avoid or delay the need for invasive ventilation
Measure: Requirement for invasive ventilation Time: through study completion up to 28 daysDescription: Through the use of CT values
Measure: Change in viral clearance Time: through study completion up to 28 daysDescription: Chest Xray
Measure: Radiological change Time: through study completion up to 28 daysDescription: As a measure of a change in inflammation
Measure: Change in white cell count Time: through study completion up to 28 daysDescription: A change in C reactive protein as a measure of a change in inflammation
Measure: C reactive protein measurement Time: through study completion up to 28 daysDescription: A change in lactate dehydrogenase as a measure of an improvement in the severity of the disease process
Measure: lactate dehydrogenase measurement Time: through study completion up to 28 daysDescription: A change in procalcitonin as a measure of an improvement in the severity of the disease process
Measure: Procalcitonin measurement Time: through study completion up to 28 daysDescription: A change in D Dimer as a measure of an improvement in the severity of the disease process
Measure: D Dimer measurement Time: through study completion up to 28 daysDescription: A change in Ferritin as a measure of an improvement in the severity of the disease process
Measure: Ferritin measurement Time: through study completion up to 28 daysDescription: A change in troponin T as a measure of an improvement in the severity of the disease process
Measure: Troponin T measurement Time: through study completion up to 28 daysDescription: A change in brain naturetic peptide as a measure of an improvement in the severity of the disease process
Measure: Brain naturetic peptide measurement Time: through study completion up to 28 daysDescription: Mortality rate due to COVID-19
Measure: Mortality rate Time: Up to 28 days of the studyHydroxychloroquine is widely used to treat autoimmune diseases. Clinical investigation has found that a high concentration of cytokines were detected in the plasma of critically ill patients infected with SARS-CoV-2, therefore, hydroxychloroquine as anti-inflammatory agents may reduce this response in accord with their use in autoimmune disease where the cytokine response can be reduced. Favipiravir is an antiviral drug developed in Japan that the data sheet notes that it is a pyrazinecarboxamide derivative with activity against influenza viruses, west nile virus, yellow fever virus, foot and mouth disease virus as well as against flaviviruses, arenaviruses, bunyaviruses and alphaviruses. In February the drug was used for COVID-19 disease in China and was declared effective in treatment, and a report published (in press) comparing Favipiravir with Lopinavir /ritonavir suggested that Favipiravir was superior for prevention of disease progression and viral clearance. The objective of this pilot study is to compare 3 arms: hydroxychloroquine; favipiravir; supportive treatment only, in symptomatic patients infected by SARS-CoV-2 in an open label randomized clinical trial. The difference between groups will allow an effect size to be determined for a definitive clinical trial
Description: Two consecutive negative (SARS-CoV-2 PCR) nasopharyngeal swabs
Measure: Primary outcome measure will be time to viral clearance Time: through study completion up to 21 daysDescription: Implementation of escalation of Respiratory Support
Measure: Requirement of Escalation of Respiratory Support Time: through study completion up to 21 daysDescription: Time frame for presenting symptoms to resolve
Measure: Time until resolution of presenting symptoms Time: through study completion up to 21 daysDescription: Monitor and document all adverse effects during therapy
Measure: Adverse effects Time: through study completion up to 21 daysDescription: Deterioration of clinical condition requiring ICU admission
Measure: Requirement of ICU Admission Time: through study completion up to 21 daysDescription: Mortality rate due to COVID-19
Measure: Mortality rate Time: Mortality will be collected at 28 daysDescription: Determination of the change in lactate levels before and after treatment as a measure of disease activity
Measure: Serum lactate measurement Time: through study completion up to 21 daysDescription: Determination of the change in ferritin levels before and after treatments as a measure of disease activity
Measure: Serum Ferritin measurement Time: through study completion up to 21 daysDescription: Determination of the change in D Dimer levels before and after treatments as a measure of disease activity
Measure: Serum D Dimer measurement Time: through study completion up to 21 daysDescription: Determination of the change in procalcitonin levels before and after treatments as a measure of disease activity
Measure: Serum procalcitonin measurement Time: through study completion up to 21 daysDescription: Determination of the change in brain naturetic peptide levels before and after treatments as a measure of disease activity
Measure: Serum brain naturetic peptide measurement Time: through study completion up to 21 daysDescription: Determination of the change in Ratio of Lymphocyte to Neutrophil, before and after treatments as a measure of disease activity
Measure: Ratio of Lymphocyte to Neutrophil, measurement Time: through study completion up to 21 days