There is one clinical trial.
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune regulation effects. This study is the first Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study at home and abroad to use immunomodulators to treat patients with COVID-19 infection.
Description: TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria: Fever - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic, 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: Time to Clinical recoveryTime to Clinical Recovery (TTCR) Time: up to 28 days
Description: baseline SpO2 during screening, PaO2/FiO2 ＜300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygenMeasure: All cause mortality Time: up to 28 days
Description: Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.Measure: Frequency of respiratory progression Time: up to 28 days
Description: in those with fever at enrolmentMeasure: Time to defervescence Time: up to 28 days
Description: in those with cough at enrolment rated severe or moderateMeasure: Time to cough reported as mild or absent Time: up to 28 days
Description: patients with moderate / severe dyspnea when enrolledMeasure: Respiratory improvement time Time: up to 28 days