|drug1262||additional blood tubes Wiki||0.58|
|drug1057||Standard Plasma (FFP) Wiki||0.58|
|drug492||High-Titer COVID-19 Convalescent Plasma (HT-CCP) Wiki||0.58|
|drug761||No Intervention Wiki||0.41|
|drug637||Lopinavir / Ritonavir Wiki||0.33|
|drug586||Interferon Beta-1A Wiki||0.33|
|drug1280||blood sampling Wiki||0.29|
|D003141||Communicable Diseases NIH||0.12|
|D045169||Severe Acute Respiratory Syndrome NIH||0.03|
|D018352||Coronavirus Infections NIH||0.03|
There are 3 clinical trials
A combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir/ ritonavir
Description: Time to negative NPS 2019-n-CoV RT-PCRMeasure: Time to negative NPS Time: Up to 1 month
Description: Time to negative saliva 2019-n-CoV RT-PCRMeasure: Time to negative saliva Time: Up to 1 month
Description: Time to NEWS of 0Measure: Time to clinical improvement Time: Up to 1 month
Description: Length of hospitalisationMeasure: Hospitalisation Time: Up to 1 month
Description: 30-day mortalityMeasure: Mortality Time: Up to 1 month
Description: Cytokine/ chemokine changesMeasure: Immune reaction Time: up to 1 month
Description: Adverse events during treatmentMeasure: Adverse events Time: up to 1 month
Description: Time to negative NPS, saliva, urine and stool 2019-n-CoV RT-PCRMeasure: Time to negative all clinical specimens Time: up to 1 month
The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
Description: Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.Measure: Time to clinical improvement Time: From date of randomization until 14 days later.
Description: If the patient dies, we have reached an outcome.Measure: Mortality Time: From date of randomization until 14 days later.
Description: Pulse-oxymetryMeasure: SpO2 Improvement Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.
Description: Incidence of new mechanical ventilation useMeasure: Incidence of new mechanical ventilation use Time: From date of randomization until 14 days later.
Description: Duration of hospitalization (days)Measure: Duration of hospitalization Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.
The novel coronavirus (SARS-CoV-2), is a single-stranded RNA coronavirus. The virus was first isolated from patients presented with pneumonia in Wuhan in December 2019. Sequences of the Wuhan betacoronavirus show similarities to betacoronaviruses found in bats, sharing a common ancestor with the 2003 SARS coronavirus (SARS-CoV) and the bat coronavirus HKU9, a virus found in fruit bats. Similar to SARS-CoV, it is a member of Beta-CoV lineage B. Five genomes of the novel coronavirus have been initially isolated and reported including BetaCoV/Wuhan/IVDC-HB-01/2019, BetaCoV/Wuhan/IVDC-HB-04/2020, BetaCoV/Wuhan/IVDC-HB-05/2019, BetaCoV/Wuhan/WIV04/2019, and BetaCoV/Wuhan/IPBCAMS-WH-01/2019 from the China CDC. The SARS-CoV-2 has since spread from China to the rest of the world. As of 5 April 2020, more than 1.05 million people been confirmed to have infected by SARS-CoV-2, resulting in more than 500,000 deaths. No specific antiviral treatment for the SARS-CoV-2 is currently available, but existing medication could be repurposed. Genetic sequencing demonstrated similarity of the SARS-CoV-2 to the SARS-CoV and MERS CoV.2 We expect patients infected with the SARS-CoV-2 will also present similarly with initial upper respiratory tract symptoms including fever, cough, sputum, myalgia and shortness or breath. More severe cases might complicate with pneumonia and required ventilatory or ECMO support. According to our previous studies in 2003 on patients hospitalized for severe SARS-CoV, the viral load peaked between day 7 from symptoms onset and coincided with clinical deterioration of pneumonia and respiratory failure, with majority of the patients required intensive care support. Higher viral load isolated from different human system also correlated with worsened SARS manifestation and complications. Previously, we have demonstrated that interferon-beta 1b, commonly used in the treatment of multiple sclerosis and lopinavir/ ritonavir, also demonstrated to improve the outcome of MERS-CoV infection in a non-human primate model of common marmoset. A non-randomized trial has also suggested that a combination of hydroxychloroquine and azithromycin might be effective in suppressing SARS-CoV-2 viral load in patients, despite in-vitro activity was only found in hydroxychloroquine. Therefore, we propose to conduct an open-label randomized controlled trial on a short course of interferon β-1b and hydroxychloroquine combination treatment for patients hospitalized for COVID-19 infection.
Description: Time to negative NPS SARS-CoV-2 viral RT-PCRMeasure: Time to negative NPS viral load Time: 4 weeks
Description: Time to complete allevation of symptoms as defined by NEWS of 0 maintained for 24 hoursMeasure: Time to NEWS 0 Time: 4 weeks
Description: Days of hospital stayMeasure: Length of Hospitalisation Time: 4 weeks
Description: Time to negative SARS-CoV-2 viral RT-PCR in all clinical samplesMeasure: Time to negative viral load in all clinical samples Time: 4 weeks
Description: Treatment related adverse eventsMeasure: Adverse events Time: 4 weeks
Description: 30-day mortalityMeasure: Mortality Time: 30 days
Description: Cytokine/ chemokineMeasure: Inflammatory markers changes Time: 4 weeks from diagnosis