CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


thalidomideWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug2950 placebo Wiki 0.27

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.06

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There is one clinical trial.

Clinical Trials


1 The Efficacy and Safety of Thalidomide in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study

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.

NCT04273529 COVID-19 Thalidomide Drug: thalidomide Drug: placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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

Secondary Outcomes

Description: baseline SpO2 during screening, PaO2/FiO2 <300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen

Measure: 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 enrolment

Measure: Time to defervescence

Time: up to 28 days

Other Outcomes

Description: in those with cough at enrolment rated severe or moderate

Measure: Time to cough reported as mild or absent

Time: up to 28 days

Description: patients with moderate / severe dyspnea when enrolled

Measure: Respiratory improvement time

Time: up to 28 days

Measure: Frequency of requirement for supplemental oxygen or non-invasive ventilation

Time: up to 28 days

Measure: Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen

Time: up to 28 days

Measure: Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve

Time: up to 28 days

Measure: Frequency of requirement for mechanical ventilation

Time: up to 28 days

Measure: Frequency of serious adverse events

Time: up to 28 days

Measure: Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10,MCP1, MIP1α and other cytokine expression levels before and after treatment

Time: up to 28 days


Related HPO nodes (Using clinical trials)