Background COVID-19 is a novel and highly virulent virus, which caused a rapid and massive onset of clinical trials in a short period of time.With the aim to obtain suggestions in the guidance on performing public health emergency clinical trials, and control this virus in China and other countries and for the prevention of the onset of other infectious viruses in the future. Methods COVID-19, SARS, MERS and Ebola clinical trials registered in the Chinese clinical trial registry and clinical trials.gov were collected and analyzed and intervention protocols were descriptively analyzed, focusing on the analysis and comparison of the drug used. The search period ended on February 24, 2020. Results The number of the registered COVID-19 clinical trials was 295. Among 203 intervention trials, 78.3% (159) were drug clinical trials. The 159 COVID-19 trials were designed and analyzed with the highest proportion of random, open control study [66.0% (105)], and blind randomized trials [13.8% (22)]. The drug mostly used was Lopinavir/Ritonavir (15.1%). The sample size median 100,IQR(interquartile range) 140. The number of the registered SARS was 6, MERS 15, and Ebola 97. Among 3 MERS and 19 Ebola drug intervention clinical trials, MERS and Ebola were randomized, blind, and placebo-controlled drug clinical trials accounting for 100% (3) and 31.6% (6), respectively, while SARS were vaccine trials, without drug intervention clinical trials registered. Conclusions Some of the COVID-19 clinical trials and drug selection performed are somewhat disordered, requiring greater attention to the needs, science assumptions, ethics and quality management of the clinical research. Thus, during the epidemic period, the country should deliver guidance on how to perform appropriate emergency clinical trials, design a scientifically based clinical trial program and focus on researching drugs or vaccines that have great potential.
and Prevention with either clinical or radiographic evidence of pneumonia or acute respiratory distress syndrome, without an alternative more likely diagnosis. Sixteen participating states § submitted case investigation forms containing data collected during January 19-June 3, 2020, for 199 COVID-19 patients. Among those patients, 192 (97%) reported experiencing any symptoms, six (3%) reported experiencing no symptoms, and one (<1%) had unknown symptom status. Sufficient symptom data for § States that submitted data include Alaska,
Introduction: More than 93,000 cases of coronavirus disease have been reported worldwide. We describe the epidemiology, clinical course, and virologic characteristics of the first 12 U.S. patients with COVID-19.
Methods:We collected demographic, exposure, and clinical information from 12 patients confirmed by CDC during January 20-February 5, 2020 to have COVID-19. Respiratory, stool, serum, and urine specimens were submitted for SARS-CoV-2 rRT-PCR testing, virus culture, and whole genome sequencing.
Results:Among the 12 patients, median age was 53 years (range: 21-68); 8 were male, 10 had traveled to China, and two were contacts of patients in this series. Commonly reported signs and symptoms at illness onset were fever (n=7) and cough (n=8). Seven patients were hospitalized with radiographic evidence of pneumonia and demonstrated clinical or laboratory signs of worsening during the second week of illness. Three were treated with the investigational antiviral remdesivir. All patients had SARS-CoV-2 RNA detected in respiratory specimens, typically for 2-3 weeks after illness onset, with lowest rRT-PCR Ct values often detected in the first week. SARS-CoV-2 RNA was detected after reported symptom resolution in seven patients. SARS-CoV-2 was cultured from respiratory specimens, and SARS-CoV-2 RNA was detected in stool from 7/10 patients.
Conclusions:In 12 patients with mild to moderately severe illness, SARS-CoV-2 RNA and viable virus were detected early, and prolonged RNA detection suggests the window for diagnosis is long. Hospitalized patients showed signs of worsening in the second week after illness onset.for use under a CC0 license.
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