Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19

Study Overview
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Brief Summary
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The mechanism of peripheral blood lymphocyte decline in COVID-19 patients is not yet clear. However, one theory demonstrated that in the whole progression of COVID-19, the extensive activation of poly-ADP-ribose polymerase (PARP) may reduce the cellular NAD+ and dampen the adaptive immune system. So investigators presume that replenishing the NAD+ using nicotinamide as the precursor may improve the lymphocyte counts and boost the adaptive immune system. As a result, the study using nicotinamide as a kind of supportive therapy provide further evidence of their efficiency and safety in treating lymphopenia in patients with COVID-19.

Official Title
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Efficiency and Safety of Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19: A Randomized Clinical Trial

Conditions
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Covid19, Lymphopenia

Intervention / Treatment
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* Drug: nicotinamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the patients diagnosed as the common or severe cases of COVID-19 aged 18-85 the absolute lymphocyte counts below the normal value (<1.1-3.2×109/L) Exclusion Criteria: the patients who are diagnosed as critically ill cases or participating in other clinical trials women who are pregnant or lactating ALT/AST > 5 times upper limit of normal (ULN), neutrophils counts < 0.5×109/L, platelets counts< 50×109/L patients diagnosed with rheumatoid immune-related diseases patients who take long-term oral anti-rejection drugs or immunomodulatory drugs hypersensitive reaction to nicotinamide or any auxiliary materials patients with active tuberculosis or combined with bacterial and fungal infections patients undergoing organ transplant patients with mental disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nicotinamide plus usual care<br> | Drug: nicotinamide<br>* In addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses<br>|
| No Intervention: usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in absolute lymphocyte counts | the changes in absolute lymphocyte counts (*10^9/L) in before and 48 hours after treatment | before and 48 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the death in hospital | the rate of death in hospital (%) | before and 48 hours after intervention | 
| the composite endpoint of aggravation | the rate of composite endpoint of aggravation(%) , according to upgraded oxygen therapy, improvement of nursing level, and ward rounds of superior physicians for changes of conditions using the time to event principle. The upgraded oxygen therapy, improvement of nursing level, and ward rounds of superior physicians for changes of conditions would be combined to the composite endpoint in percentage (%). The upgraded oxygen therapy was defined as upgrading of ge neral high-volume oxygen intake from oxygen intake, ventilator using from high-volume oxygen intake or transference to intensive care unit from ventilator using. | before and 48 hours after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotinamide, COVID19, lymphopenia