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Report for Clinical Trial NCT04273581

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study

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. Patients with severe COVID-19 have rapid disease progression and high mortality. There is currently no effective treatment method, which may be related to the excessive immune response caused by cytokine storm. This study will evaluate thalidomide combined with low-dose hormone adjuvant therapy for severe COVID-19 Patient effectiveness and safety.

NCT04273581 COVID-19 Thalidomide

2 Interventions

Name: placebo

Description: 100mg/d,qn,for 14 days.
Type: Drug
Group Labels: 1

Control group

Name: Thalidomide

Description: 100mg/d,qn,for 14 days.
Type: Drug
Group Labels: 1

Thalidomide group


Primary Outcomes

Description: TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.

Measure: Time to Clinical Improvement (TTCI)

Time: up to 28 days

Secondary Outcomes

Description: Clinical status, assessed by the ordinal scale at fixed time points

Measure: Clinical status

Time: days 7, 14, 21, and 28

Measure: Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours

Time: up to 28 days

Measure: All cause mortality

Time: up to 28 days

Measure: Duration (days) of mechanical ventilation

Time: up to 28 days

Measure: Duration (days) of extracorporeal membrane oxygenation

Time: up to 28 days

Measure: Duration (days) of supplemental oxygenation

Time: up to 28 days

Measure: Length of hospital stay (days)

Time: up to 28 days

Measure: Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens

Time: up to 28 days

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

Time: up to 28 days

Measure: Frequency of serious adverse drug 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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V140A

There is currently no effective treatment method, which may be related to the excessive immune response caused by cytokine storm.It has been reported that the combined use of thalidomide and dexamethasone can effectively inhibit NK / T-cell lymphoma combined with ECSIT V140A mutation of hematophilic syndrome. --- V140A ---



HPO Nodes